1

Abstract of dissertation entitled

“An evidenced-based guideline on cold application prior to the removal of chest

tubes to reduce pain in cardiothoracic surgical patients”

Submitted by

Yim Tin Chee

For the degree of Master of Nursing at the University of Hong Kong

in July 2015

Chest tubes are commonly inserted during cardiothoracic surgery (CTS) in order

to drain air and fluid out from the pleural cavity. Chest tube removal (CTR) will be

performed by the physician if the drainage amount is adequate. Nevertheless, CTS

patients have reported unpleasant painful experiences during CTR. They are highly

susceptible to postoperative complications and thus delay their recovery processes and

increase the medical costs for these uncontrolled pains. Both CTS patients and the

medical institution can share the benefits if an effective and evidence based

intervention can be introduced.

The aims of this dissertation are to evaluate the current evidences of applying

cold application prior to CTR to reduce pain in CTS patients, to develop a

standardized and evidence based protocol for nurses by using pharmacological and

non-pharmacological methods to manage pain suffered by CTS patients during CTR,

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to assess its transferability and feasibility and discuss the implementation designs in

CTS units in Hong Kong. Finally, an evaluation plan will be developed to evaluate the

clinical outcomes.

There were seven articles included which related to the use of cold application to

relieve pain for CTS patients during CTR. Checklist designed by the Scottish

Intercollegiate Guidelines Network (SIGN) was used to evaluate the methodological

quality of the selected articles. Six articles were rated as acceptable in methodological

quality which successfully demonstrated better pain relieving effect in cold

application group when compared with control group immediately and certain period

after CTR.

A nurse driven evidence based guideline has been created after literature review.

The implementation potential of the guideline in local CTS units has been examined.

A working group consists of administrators, experienced and frontline staffs will be

responsible to guide the programme implementation. Feedbacks for the guideline are

collected via communication between the group members and other frontline staffs.

The feasibility of the programme will be determined based on the results of the pilot

study. The patient’s outcomes, healthcare provider outcomes and system outcomes

will be monitored by the working group annually to determine the worthiness of the

programme.

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An evidenced-based guideline on cold application prior to the

removal of chest tubes to reduce pain in cardiothoracic surgical

patients

by

Yim Tin Chee

BN, RN

A thesis submitted in partial fulfillment of the requirements for the Degree of

Master of Nursing at the University of Hong Kong.

July 2015

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Declaration

I declare that this thesis represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

Signed: Yim Tin Chee

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Acknowledgements

I would like to express my sincere gratitude to my dissertation supervisor, Dr

Janet Wong (Assistant Professor), who has provided invaluable guidance,

encouragement and expert opinions throughout the 2 years dissertation preparations.

Beside, I would also like to thank my dear classmates of the Master of Nursing

programme (2015) and hospital colleagues, who have supported and given me

encouragement throughout the study.

Finally, I would like to express my deepest gratitude to my family for their

greatest support during my 2 years study. Without their support, I cannot concentrate

to complete these 2 years study.

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Content Page

Dissertation abstract P.1

Declaration P.4

Acknowledgements P.5

Chapter 1: Introduction

1.1: Background of the study issue P.10

1.2: Affirming need of the study issue P.11

1.3: Objectives and significance P.13

Chapter 2: Critical appraisal

2.1: Search and appraisal strategies

2.1.1: Databases searching P.15

2.1.2: Inclusion and exclusion criteria P.15

2.1.3: Data extraction P.15

2.1.4: Appraisal strategies P.16

2.2: Results

2.2.1: Date of search and search history P.17

2.2.2: Study characteristics P.17

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2.2.3: Methodological Quality P.18

2.3: Summary and synthesis

2.3.1: Summary of results P.21

2.3.2: Synthesis of results P.24

2.3.3: Conclusion P.29

Chapter 3: Implementation potential and clinical guideline

3.1: Transferability of findings

3.1.1: Target setting and population P.31

3.1.2: Similarities and differences between local and literature settings P.32

3.1.3: Philosophy of care P.32

3.1.4: Periods for implementation and evaluation P.33

3.2: Feasibility of findings

3.2.1: Manpower and attitudes of the nurses P.33

3.2.2: Training sessions and environment P.34

3.2.3: Multi-discipline co-operations P.35

3.2.4: Tools for evaluation P.36

3.3: Costs and Benefits

3.3.1: Individual benefits and risks P.37

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3.3.2: Material costs of the institution P.39

3.3.3: Non-material costs of the institution P.40

3.4: Evidence-based practice guideline

3.4.1: Guideline title P.41

3.4.2: Objectives P.41

3.4.3: Target populations P.42

3.4.4: Evidence based recommendations P.42

Chapter 4: Implementation plan

4.1: Communication plan--- An overview

4.1.1: Stakeholders identification P.44

4.1.2: Forming a working group P.45

4.1.3: Roles of working group P.46

4.2: Pilot study plan

4.2.1: Patient’s recruitment P.49

4.2.2: Rundown testing P.49

4.2.3: Pilot study evaluations P.50

4.3: Evaluation plan

4.3.1: Patient outcomes P.51

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4.3.2: Healthcare provider outcomes P.52

4.3.3: Systems outcomes P.52

4.3.4: Data measurements and analysis P.53

4.3.4.1: Patients outcomes P.53

4.3.4.2: Healthcare provider outcomes P.55

4.3.4.3: System outcomes P.55

4.4: Basis for implementation P.55

Conclusion P.56

References P.56

Appendices P.62

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Chapter 1: Introduction

1.1: Background of the study issue

Chest tubes are commonly inserted during cardiothoracic surgeries (CTS), such

as coronary artery bypass grafting with or without heart valves repair and lobectomy

(Mitra, Nahid, Nouraddin & Eskandar, 2014; Sauls, 2002), in order to drain air and

fluid out from the pleural cavity (Demir & Khorsbid, 2010; Ertug & Ulker, 2011).

Chest tubes will be removed by the physicians when the drainage amount is adequate

(Gorji, Nesami, Ayyasi, Ghafari & Yazdani, 2014). Chest tube removal (CTR) is

described as a painful experience by the patients (Demir & Khorsbid, 2010; Sauls,

2002). Chest tube adheres to the endothelium of the pleural cavity. Pulling effort

during CTR will detach this adhesion causing sharp pain to the patients (Demir &

Khorshid, 2010).

In order to help relieve the pain suffered by these patients during CTR,

traditional pharmacological method such as acetaminophen and morphine are

prescribed to the patients by providing anti-inflammatory effect and directly acting on

central nervous system respectively (Mitra et al., 2014). For non-pharmacological

method, cold application was considered to be applied to these patients to reduce their

pain. Cold packs (silica gel) or ice bags are common materials used in cold

application (Kol, Erdogan, Karsh & Erbil, 2013). It was thought that cold application

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could reduce the pain impulse transmission velocity and block the pain signal

transmission from the periphery pain receptors to the spinal cord (Yagiz, 2006, as

cited in Kol et al., 2013). However, the evidence of the effect of cold application

before CTR to reduce procedural pain in CTS patients is unclear.

1.2: Affirming need of the study issue

My working place is a surgical ward which involves postoperative CTS cases.

Around 17 chest tubes will be removed each month for these patients by official

statistics (NTWC, 2014). Usually, CTR are done by physicians at their convenient

time without noticing the responsible nurses prior the procedure. Therefore,

analgesics are given at the time of starting the procedure. There is not enough time for

the drugs to exert its therapeutic effects in reducing pain suffered by the patients

during the procedure. To conclude, preparations for CTR to the patients are hurried

and inadequate.

Majority of patients reported intense pain during CTR and moderate pain after

CTR even though analgesics (panadol or tramadol tablets) are given before and after

the procedure. Complications such as decrease in chest expansion, tachycardia and

myocardial infarction can be resulted if these unrelieved pain are neglected, especially

for the CTS patients (Gorji et al., 2014). Therefore, it is crucial and ethical for nurses

to have an accurate pain assessment, charting and management to the pain complains

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by the patients (Demir & Khorshid, 2010; Mitra et al., 2014; Sauls, 2002).

To relieve these procedural pains in a better way, several potent drugs such as

midazolam and acetaminophen in intravenous form can be considered. However,

these drugs may create some cardiovascular side effects which are particularly

vulnerable for those CTS patients and the pain relieving effects by using drugs alone

are not efficacious (Gorji et al., 2014; Mitra et al., 2014). On the other hand,

non-pharmacological method such as cold application is being considered as an

alternative. Various studies had proven that cold application could help increase the

tolerance to pain and decrease the request for analgesics for the orthopedic and

gynecologic surgical patients by decreasing the speed of pain impulse conduction and

producing anti-inflammatory effect (Demir & Khorshid, 2010; Sauls, 2002). When

compared with pharmacological methods, cold application does not introduce harmful

chemical substances to the body and does not produce unexpected physiological

effects to the patients (Ertug & Ulker, 2011). Another advantage for cold application

is that it is simple and easy to be applied by the nurses. Finally, silica gel packs or ice

bags are cheap in prices which can help decrease the cost in applying cold application

to the patients (Demir & Khorshid, 2010).

Although cold application has been shown to be helpful for various surgical

pains, no systematic reviews have been conducted to demonstrate the evidence to

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CTR procedural pain. Also, some contradictory results arose from previous studies

regarding to the control of CTR procedural pain in using cold application (Demir &

Khorshid, 2010). Therefore, the existing articles related to the effect of cold

application on CTR procedural pain are systematically reviewed by comparing the

methodologies applied during the studies in this translational research.

1.3: Objectives and Significance

The translational research question is listed below in PICO format:

1: Patient (P): CTS patients who are going to undergo CTR procedure.

2: Intervention group (I): CTS patients with cold application applied before CTR

procedure.

3: Comparison group (C): CTS patients without cold application applied before CTR

procedure.

4: Outcomes (O): Pain level perceived by the CTS patients immediately and 15

minutes after CTR procedure.

The objectives of this translational research:

1: To evaluate the current evidences of cold application on CTR pain control by

comparing methodology quality of various related studies.

2: To establish an evidence-based guideline for the nurses in implementing cold

application before CTR for the CTS patients.

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3: To assess the potential and possibility of transferring ‘cold application before CTR’

guideline to the CTS units among Hong Kong hospitals.

4: To evaluate the cost-effectiveness and the difficulties encountered by the nurses

when implementing ‘cold application before CTR’ guideline.

The significance of this study:

Pain is regarded as the fifth vital sign in assessing patients’ general condition

(Ertug & Ulker, 2011). If cold application is effective in controlling procedural pain

during CTR for the CTS patients, the chance of having respiratory and cardiovascular

complications can be reduced (Gorji et al., 2014). In addition, uncontrolled pain

suffered during CTR may increase the anxiety level being felt by the patients, poor

surgical outcomes may result (Demir & Khorshid, 2010). Finally, with an effective

pain management method provided by the nurses before CTR, patients will feel that

they are being cared and build a rapport relationship with their nurses, which can

enhance recovery.

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Chapter 2: Critical appraisal

2.1: Search and appraisal strategies

2.1.1: Databases searching

Two electronic data bases were used during the initial search, which were

Pubmed and CINAHL. The keywords used during the search were “cardiac patients”,

“thoracic surgery patients”, “cardiothoracic patients”, “cold application”,

“cryotherapy”, “chest tube removal”, “chest drain removal” and “pain”. After

keywords search, each article yielded from the initial search was reviewed by title,

abstract and full text respectively to assess for relevance. The reference list of each

article had also been reviewed to find out related articles. To enrich the findings,

Google scholar was used as a final resource for searching by using the same

keywords.

2.1.2: Inclusion and exclusion criteria

Inclusion and exclusion criteria were established during the search. The inclusion

criteria included adults (>18 years old), orientated to time, place and person, able to

rate pain level by using pain scores. The exclusion criteria included patients with

psychiatric diseases and hypersensitive to cold application.

2.1.3: Data extraction

After collecting the articles, data were extracted from each of them. The

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extracted items included bibliographic citation, study type, sample characteristics,

cold application and comparison groups’ implementation details, length of follow up,

outcome measurements and effect sizes of the study. These items were then elaborated

in a table as shown in Appendix 2.

2.1.4: Appraisal strategies

The quality of the studies in terms of methodology was rated according to the

guidelines listed on the methodology checklist by the Scottish Intercollegiate

Guidelines Network (SIGN) (Scottish Intercollegiate Guidelines Network, 2014). This

checklist consists of two parts, which are internal validity and overall assessment of

the study. Main items in the internal validity part included the appropriateness of the

study question, the randomization and concealment methods used when assigning

patients into different groups, the use of blinding methods, the demographic

differences among the patients before the study, the reliability and validity of the tools

used for measuring outcomes, the drop out rate, the intention-to-treat approach in

analyzing the effects of drop out patients and the comparison of study results among

various study sites if any. For the overall assessment part, the effort of diminishing

biases by the researchers, the statistical power of the sample, the applicability of the

intervention and generalizability of the study results are assessed. These items will be

evaluated to conclude whether the quality of study is rated as high quality (++),

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acceptable (+) or unacceptable (reject 0).

2.2: Results

2.2.1: Date of search and search history

The articles were searched from March 2014 to July 2014. In total, 4 articles

were found from Pubmed and CINAHL during the initial search. The reference lists of

these 4 articles were assessed and 13 articles were found to be related after reviewing

titles, abstracts and full texts. To enrich the findings, Google scholar was used as a

final database for searching and yielded 1 more article. After removing duplications, 7

articles were included. English language was found in 6 articles and 1 article in

Persian. Randomized controlled trial (RCT) study was found in 6 articles while 1

article was controlled trial study without randomization. All of the studies were

related to the cold application around the skin of the chest tubes for the CTS patients

before CTR and the pain levels perceived by the patients immediately and after the

procedure were assessed. Appendix 1 had shown details about the searching history.

2.2.2: Study characteristics

From the 7 included articles, all of them were prospective design studies. RCT

study was found in 6 articles while 1 article was controlled trial (CT) study without

randomization. Moreover, 2 articles were crossover design studies. These studies

conducted in various countries, including 1 from Saudi Arabia, 1 from USA, 2 from

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Turkey and 3 from Iran. No local study was found after the search. Cardiac surgical

patients were focused in 5 articles, thoracic surgical patients were focused in 1 article

and both cardiac and thoracic surgical patients were focused in 1 article. Each patient

has at least 2 chest tubes (pericardial, mediastinal or pleural chest tubes) in 6 articles

and 1 chest tube in 1 article. Regarding the interventions, cold application was applied

in combination with pharmacological method in 5 articles (acetaminophen in oral or

intravenous form, indomethacin suppository or midazolam in intravenous form) and

cold application was applied alone in 2 articles. Ice packs were applied to the patients

in 3 articles while cold gel packs were applied in 4 articles. When compared with the

study sites, 5 of the studies conducted in ICU, 1 in CCU and 3 in postoperative

surgical units. Multisite studies were found in 2 articles. Table of evidence was shown

in Appendix 2 for details.

2.2.3: Methodological Quality

All the articles had mentioned a clear and appropriate PICO question. Although

randomization was mentioned when assigning patients into different groups for 6

RCT studies, only 2 articles mentioned the randomization methods in details. These

methods included assigning patients into different groups according to the random

numbers generated by the Excel software in the computer (Gorji et al., 2014) and

drawn out cards coded with 3 groups randomly by the researchers for each patient

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before the crossover study (Mazloum, Abbasi, Kianinejad & Gandomkar, 2012). For

the controlled trial article, the patients were assigned to the groups according to the

odd-dated days and even-dated days of being recruited in the month without

randomization (Ertug & Ulker, 2011). However, no concealment methods to the

researchers were clearly mentioned when assigning patients into different groups for

all the articles.

Single blinding method was used in 5 articles. Patients were ‘blinded’ for 4

articles and assessor was ‘blinded’ in 1 article. Patients could only be ‘blinded’ for

those studies with a placebo group (placebo bag application). The nurse for recording

pain level was trained and was ‘blinded’ to the treatments being applied to the patients

in Gorji et al. (2014) study. This could help increase the inter-rater reliability during

the measurement.

The demographic characteristics of the patients in intervention and comparison

groups were similar for all the articles before the studies began. However, the pain

level before CTR between the cold application and placebo groups showed a

significant difference in Otaibi, Mokabel & Ghuneimy (2013) study, which affected

the rigor of the results.

The only difference between the intervention and control groups was the

treatment applied to the corresponding group. CTR was performed by 1 health care

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professional (Demir & Khorshid, 2010; Gorji et al., 2014; Mitra et al., 2014) or by

few physicians following a standard protocol (Ertug & Ulker, 2011). Nevertheless, in

Sauls (2002) article, the investigator present during the procedure had provided

explanations to some of the patients on request, which might cause another difference

in treatment between the groups. Moreover, 7 health care professionals of different

expertise performed CTR, which might create some extraneous variables.

Pain level was the main primary outcome for all the studies, which was measured

by numerical rating scale (NRS) (Sauls, 2002) or visual analogue scale (VAS) for the

other 6 articles. Anxiety level was measured in 3 studies (Demir & Khorshid, 2010;

Otaibi et al., 2013; Sauls, 2002). Reliability and validity of the measuring tools were

supported by previous literatures for all the articles. No patients dropped out from all

the studies but only occurred in Mitra et al., (2014) article. The drop out percentage

was 3.03%, which was less than 20% and regarded as acceptable (SIGN, 2012).

Nevertheless, no intention-to-treat analysis was conducted to analyze these dropped

out patients.

Not all the articles mentioned the statistical power of the samples. To minimize

type 2 error, sample size of power >0.8 and alpha <0.05 should be needed. 0.81 was

reported in Demir & Khorshid (2010) study while 0.99 were reported in Ertug &

Ulker (2011) and Gorji et al. (2014) studies. When viewing the sample size, Sauls

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(2002), Otaibi et al. (2013) and Mitra et al. (2014) articles showed inadequate patients.

This might affect results generalizability.

Although 2 studies were conducted in multisite (Otaibi et al. 2013; Sauls, 2002),

none of them provided specific results obtained in particular site in order to have a

comparison.

In general speaking, all the articles were rated acceptable (+) except Sauls (2002)

study, which was rated unacceptable (0). Nevertheless, Sauls (2002) article was the

earliest study related to the cold application before CTR and latter studies had revised

the methods used based on it. Therefore, this study can still act as a reference material.

Details of the methodology quality refer to Appendix 3.

2.3: Summary and synthesis

2.3.1: Summary of results

There was a significant decreased in pain level (p<0.05) perceived by the

patients in the cold application group when compared with those in the comparison

groups (placebo or control groups) immediately after CTR for all the articles except

Sauls (2002) study, which showed a non-significant decreased in pain level (p>0.05).

The sustained effect of cold application on pain level was measured 15 minutes after

CTR for 5 articles (Demir & Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012;

Mitra et al., 2014; Otaibi et al., 2013) and 5 minutes after CTR (Ertug & Ulker, 2011).

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All of them showed a significant decreased in pain level (p<0.05) in cold application

group when compared with the comparison groups. Nevertheless, there were

non-significant decreased in pain level (p>0.05) in Sauls (2002) study 10 minutes

after CTR and Mitra et al. (2014) 15 minutes after CTR.

Apart from pain level, 3 articles had reported anxiety level perceived by the

patients after CTR. In Otaibi et al. (2013) article, the anxiety scores measured by

using Hamilton anxiety rating scale (HAM-A) showed a significant decreased in

anxiety level after CTR. However, in Demir & Khorshid (2010) article, the anxiety

scores recorded by using Spielberger situational anxiety level inventory (STAI-I)

showed a non-significant decreased in anxiety level (p>0.05) in cold application

group 15 minutes after CTR when compared with both placebo and control groups.

Non-significant results also produced in Sauls (2002) article, in which the distress

level for either immediately or 10 minutes after CTR showed non-significant results

(p>0.05).

The mean ages of the participants were ranged from 55-60 years old for 5 articles

(Demir & Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014;

Sauls, 2002) while 2 articles showed mean ages from 40-50 years old (Ertug & Ulker,

2011; Otaibi et al., 2013). 5 articles combined cold application with pharmacological

method together before CTR. In Demir & Khorshid (2010) study, 10mg/kg

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paracetamol in intravenous form was injected 60 minutes before CTR for all the

groups. Both Gorji et al. (2014) and Otaibi et al. (2013) studies prescribed

acetaminophen oral pills as their pharmacological method. In Otaibi et al. (2013)

study, 1 gram acetaminophen oral pills were given 60 minutes before CTR while for

the Gorji et al. (2014) study, acetaminophen pills were given round the clock for every

6 hours without mentioning the dosage given each time. For Mitra et al. (2014) study,

indomethacin suppository of 100mg was inserted 60 minutes before CTR. Finally,

unmentioned dosage of midazolam in intravenous form was given to all groups before

CTR in Mazloum et al. (2012) study.

The selected articles had reported different cold application area around the chest

tubes. In Sauls (2002) article, a cold pack was applied at either side of the chest tubes

by covering 38.7cm² of the skin while in Ertug & Ulker (2011) study, cold packs were

applied around the chest tube covering 6.125cm² of the skin. In Demir & Khorshid

(2010) study, a cold pack was bent and being applied around the chest tubes

occupying 5 cm³ of the skin. Cold packs were applied around skin of the chest tubes

for other articles but no specific area was being mentioned. Besides, the length of time

in applying cold application was different in the selected articles. 10 minutes was

spent in cold application before CTR in Sauls (2002) study while 20 minutes was

spent in Demir & Khorshid (2010), Mazloum et al. (2012) and Mitra et al. (2014)

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studies. Temperature measurement was another indicator for the time length of cold

packs application. In both Ertug & Ulker (2011), Gorji et al. (2014) and Otaibi et al.

(2013) studies, cold packs would be removed when the skin temperature around the

chest tubes reached 13°C. Appendix 2 had shown detailed results.

2.3.2: Synthesis of results

Among all the selected articles, all of them showed statistically significant results

in decreasing pain level in cold application group when compared with comparison

groups immediately after CTR except in Sauls (2002) study. Cold application effect

on decreasing pain level also sustained for a period of time among the majority of the

selected studies, except Sauls (2002) and Mitra et al. (2014) studies.

The contradictory results on pain level in cold application group showed by

Sauls (2002) article could be due to several factors. Firstly, the ice pack applied only

to either side of the chest tube but not totally covered the surrounding skin, which

might weaken the cooling effect. In addition, spending 10 minutes for applying the ice

pack by the health care professional was too short and inadequate for the ice pack to

produce cooling effect thoroughly. On top of this, to determine whether the effect was

due to cold application or not, placebo group was used. A tap water pack of 30.6°C to

31.7°C was applied to the patients in placebo group, which might actually cool down

the skin of the patients in placebo group. Moreover, the patients were not ‘blinded’ to

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the treatments and the differences between the two groups were not only the treatment

itself, but also the extra explanations provided by the investigator to patients on

requests, which created extraneous variables to the study. Finally, the sample size

(n=25 for each group) was small, which increased the chance of accepting a null

hypothesis (Type 2 error). Although power analysis was not mentioned in Mitra et al.

(2014) article, by estimation, the sample size was not adequate as only 32 patients in

the cold application group and 34 patients in placebo group. In addition, the study did

not apply intention-to-treat analysis with the results of 2 withdrawn patients in the

cold application group being ignored, which might contribute to the non-significant

result in pain level 15 minutes after CTR.

In contrast, cold packs were applied and covered certain area of the skin

surrounding the chest tubes in the cold application group instead of covering just one

side of the skin among all the articles selected. For the intervention duration, cold

application time extended from 10 minutes to 20 minutes (Demir & Khorshid, 2010;

Mazloum et al., 2012; Mitra et al., 2014) or used temperature reading (13°C) as an

indicator to ensure adequate cooling (Ertug & Ulker, 2011; Gorji et al., 2014; Otaibi et

al., 2013). Furthermore, 2 comparison groups (placebo and control groups) were used

(Demir & Khorshid, 2010; Mazloum et al., 2012). The present of placebo packs might

somehow provided some cooling effect to the skin and also caused patients to think

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that placebo bags could help reduce their pain, which affected their perception of pain

(Bal, 2002; Kocaman, 1994, as cited in Demir & Khorshid, 2010). The control group

could help counteract these effects in the placebo group. Single blinding method was

used by either ‘blinded’ the patients between cold application and placebo groups

(Demir & Khorshid, 2010; Mazloum et al., 2012; Otaibi et al., 2013; Mitra et al., 2014)

or ‘blinded’ the assessor to the treatments being received by the patients (Gorji et al.,

2014), which could reduce biases to the results. Finally, adequate sample sizes of

power 0.81 in Demir & Khorshid (2010) and power 0.99 in Ertug & Ulker (2011) and

Gorji et al. (2014) studies could help reduce Type 2 error. These improvements help

contribute to significant results.

Effect size of pain control by applying combination method (cold application +

pharmacological method) and cold application alone could be compared. The effect

size immediately after CTR was the largest in Otaibi et al. (2013) combination

method study, which was -5.95. However, only 40 patients were recruited during the

study. Although there was no mention about the power analysis of the study, the

sample size 40 in this study was lesser than Sauls (2002) article, which recruited 50

patients and produced non-significant results. By estimation, the power of the sample

was small to generalize the result to other patients. The second large effect size was

Gorji et al. (2014) combination method study, which was -2.2. Several factors

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contributed this study to get a large effect size, such as a good randomization method

was used by generating random numbers from the Excel programme in computer for

assigning patients into different groups, single blinding method was used to ‘blinded’

the assessor to the treatments before CTR and adequate sample size (power = 0.99 for

alpha <0.05). The largest effect size in cold application alone study was Ertug &

Ulker (2011), which was -1.75. The effect size in Ertug & Ulker (2011) article was

lower than Gorji et al. (2014) article. Although the effect size for 15 minutes after

CTR was small in Gorji et al. (2014) article, which was -0.22, the mean pain score for

the cold application group was 0.42 and was lower than Sauls (2002) and Ertug &

Ulker (2011) articles, which were 1.68 and 1.13 respectively.

In summary, combination method seemed to be more effective in pain control

when compared with cold application alone. One has to notice that in Mazloum et al.

(2012) study, although the effect size had shown significant reduction in pain levels

immediately and 15 minutes after CTR and the mean pain scores of the cold

application group were low, which were 2.5 and 0.6 respectively, the midazolam used

in this study might increase the chance of having complications and required close

monitoring for the CTS patients as discussed before. Therefore, it was not suitable to

be used in common postoperative CTS units.

In view of the demographic characteristics of the patients among the articles

28

being selected, the mean ages of the patients ranged from 40-60 years old and BMI<

30kg/m², which were somehow homogenous. However, there was lack of report about

the religious belief and cultural background of the patients. These factors would affect

the perception to pain by the patients (Mitra et al., 2014). Finally, only Ertug & Ulker

(2011) and Gorji et al. (2014) recruited patients with no CTR experience before the

studies. Patients might compare current event with their previous experience, which

affected their true pain perception (Ertug & Ulker, 2011).

Anxiety level experienced by the patients during CTR was another primary

outcome being reported in 3 selected articles (Demir & Khorshid, 2010; Otaibi et al.,

2013; Sauls, 2002). Anxiety was regarded as an indicator for postoperative pain, the

increase in its level would reduce pain threshold of the patients which leaded to pain

level overestimation. It was thought that the increase in pain level contributed to the

increase in anxiety level and vice versa (Milikan et al., 2008, as cited in Otaibi et al.,

2013). In Otaibi et al (2013) study, the anxiety level measured by HAM-A scale had

shown a significant reduction (p<0.05) in cold application group when compared with

the placebo group. The correlation between pre-CTR anxiety level and pain level 15

minutes after CTR were significant (p<0.05). On the other hand, both the Sauls (2002)

and Demir & Khorshid (2010) showed non-significant results in decreasing anxiety

level in cold application group when compared with the comparison groups. These

29

results could be explained by the environmental factors. Several patients were

assigned in a room and the medical activities of the other patients might distract and

affect the anxiety level perceived by the patients who were undergoing CTR (Sauls,

2002). In addition, the small sample size in Sauls (2002) article also affected the

results generalizability. However, the variations of anxiety levels were the same trend

as the variations of pain levels during and after CTR for these two studies, which

supported the previous literature findings. In view of this importance, future studies

should report anxiety levels experienced by the patients during and after CTR to study

its relationship with pain level perception.

2.3.3: Conclusion

After analyzing these articles, conclusions are made here,

1: Applying cold application for CTS patients before CTR is efficacious in reducing

pain level perceived by them immediately and effect sustained certain time after CTR.

2: Combination method (pharmacological method + cold application) is more

effective in pain control than applying cold application alone.

3: Anxiety level is an important indicator for pain level perceived by the patients.

Future studies should report the correlation between anxiety level and pain level

perceptions.

4: Cultural background and religious belief of the patients should be reported in the

30

future studies as these factors may affect patient’s pain perception.

5: Cold application is a cheap, safe and easy to handle intervention. This intervention

is worth and has potential to be transferred to local hospitals.

31

Chapter 3: Translation and application

After reviewing the selected clinical studies, it has been shown that applying

cold application to the CTS patients before CTR is efficacious in reducing pain level

perceived by them immediately and certain period after CTR. Although the effects of

this new programme have been demonstrated in previous literatures, the

implementation potential in terms of transferability, feasibility and cost and benefits

of this new programme should be examined to determine whether it is suitable to be

implemented in the local setting and deserves to be maintained in the long run.

3.1: Transferability of findings

3.1.1: Target setting and population

The local setting for implementing this new programme is a male postoperative

surgical ward, which is a main cluster hospital and includes CTS cases. According to

the Hospital Authority (2006-2010) surgical statistics, there were 150 CTS patients in

this hospital from 2008 to 2009, in which 138 patients received ultra-major to major

surgeries. The number increased to 209 patients from 2009-2010, in which 181

patients received ultra-major to major surgeries. Chest tubes are usually inserted after

CTS ((Mitra et al., 2014; Sauls, 2002) and the increase in CTS patients each year also

indicates that more of them can benefit from this new programme when undergoing

CTR.

32

3.1.2: Similarities and differences between local and literature settings

Basically, the characteristics of the patients were similar for both local and those

mentioned in the literatures, including the age ranges, the type of surgery performed,

the locations of the chest tubes and the settings in performing CTR. Nevertheless,

some of patients underwent major surgeries or required critical care might create

minor difference in pain perception, for examples, cardiac surgeries (Demir &

Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014; Sauls,

2002), pericardial and mediastinal chest tubes (Gorji et al., 2014; Mazloum et al.,

2012; Mitra et al., 2014; Otaibi et al., 2013), critical cases in ICU or CCU (Demir and

Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014; Sauls,

2002).

Besides, there were no Chinese patients being recruited in the literatures.

Although patients of different nationalities might affect their pain perceptions due to

cultural and religious differences, patients in both settings reported great discomfort

during CTR. Therefore, new pain management should be considered to relieve their

pain. Detailed comparisons of patient’s characteristics have been shown in Appendix

4.

3.1.3: Philosophy of care

The prevailing philosophy of CTS care in the local setting is to reduce the event

33

of postoperative complications such as pneumonia, atelectasis and cardiovascular

associated problems, which will increase the fatal probability after the surgery. In

view of this, the new programme introduced is compatible to the philosophy of CTS

unit in the local setting, which focuses on pain relief of patients during CTR

procedure to reduce the event of associated cardiothoracic complications.

Nevertheless, this new programme introduces cold application as a non-invasive

approach to relieve patient’s pain during CTR procedure, which is different from the

prevailing local setting by using invasive pharmacological methods. The non-invasive

approach in this new programme can help reduce the vulnerability caused by

traditional invasive pharmacological methods to the CTS patients.

3.1.4: Periods for implementation and evaluation

In this new programme, panadol in oral form will be given 1 hour before CTR

and regularly every 6 hours after CTR for 1 day. The cold application takes around 20

minutes before CTR and the effect can be observed immediately and sustains around

15 minutes after CTR for each patient. The effect of this new intervention can be

evaluated 6 months and annually after the implementation.

3.2: Feasibility of findings

3.2.1: Manpower and attitudes of the nurses

There are 25 nurses in the target ward. Less than half of them have the

34

experience of 6 years or above working experiences in surgical unit while the

remaining nurses have 3 years or below experiences. Although lack of senior nurses

may affect service quality, most of the junior nurses are graduated from universities

and studied evidence based practices before. They are more willing to commit

changes and easy for them to accept and digest the new findings (Alanen, Valimaki &

Kaila, 2009).

Attitudes of the nurses are crucial for implementing an innovative programme

(Alanen et al., 2009). Firstly, the departmental manager (DOM) and ward manager

advocate nurses to use eKG database in intranet to update their nursing knowledge.

They also encourage nurses to bring up Kaizen projects in order to improve the

nursing care in ward. On the other hand, the majority of the nurses in the target ward

recognize that the pain control for CTS patients during CTR is not good and higher

chance for them to suffer from respiratory and cardiovascular complications. These

complications delay the recovery process and increase the time and workload for the

nurses to close monitor their patients. Therefore, they are willing to explore changes

to improve this situation.

3.2.2: Training sessions and environment

This new programme consists of two parts, which are drug administration and

cold application. Administration of medication is the daily work for all the nurses and

35

they are already familiar with the procedures (3 checks 5 rights). Therefore, cold

application training should be provided since all the nurses in the local setting are not

familiar with it. There will be total 3 training sessions in 3 consecutive weeks, i.e. 1

week with 1 training session. Each training session is 1 hour in duration. Each nurse

only needs to attend 1 session since the contents of all sessions are the same. The

training sessions will be hold at treatment room in the ward from 14:30 to 15:30. This

time arrangement can facilitate A shift nurses to attend after duty handover and the

treatment room is usually available during that period. The treatment room is a place

for performing minor operations and dressing materials such as dressing pads are

located there. It is spacious enough to accommodate a group of nurses to attend the

training and also a preferred place for performing CTR.

Total 8 nurses are recruited in each training session. The training sessions

consists of 2 parts, which are demonstration and re-demonstration parts. A senior

physiotherapist in the same hospital will be invited by ward manager as a speaker

since physiotherapist has more experience in applying cold application to reduce

muscle and inflammatory related pains (Gorji et al., 2014). A nurse will be invited as a

real model for the physiotherapist to demonstrate the cold application procedure. After

demonstration, 2 nurses will form a group and re-demonstrate the techniques.

3.2.3: Multi-discipline co-operations

36

A good co-operation between nurses and other disciplines is a crucial factor for

implementing a new programme successfully (Alanen et al., 2009). There are good

experiences in co-operation between doctors, nurses and other allied health disciplines,

such as colorectal fast tract patient care project in the target ward. This programme

enhances the recovery of colorectal patients after the surgery. With this previous

experience, multi-discipline co-operations should be easily established for this new

programme.

In usual practice, doctors perform CTR in their convenient time without noticing

the responsible nurses. Lack of preparation time will affect the implementation of this

new programme. The DOM and the ward manager can hold a meeting with the

consultants of CTS to discuss the issues including the benefits of implementing this

new programme and improve the communications between doctors and nurses.

The support from physiotherapists is also important. According to Kol, Erdogan,

Karsh & Erbil (2013), the pain caused by the CTR may increase postoperative

atelectasis and delay the recovery process. Therefore, they should be welcome to be

invited as a speaker in cold application training and share their experiences.

3.2.4: Tools for evaluation

As mentioned in the literatures, visual analogue scale (VAS) was used for

patients to rate pain level. Nurses in the target ward were needed to record pain level

37

of their patients per shift by using numerical rating scale (NRS) instead of VAS. The

advantage of using VAS over NRS is that it facilitates the measurement in continuum

and in normal distribution, which can provide higher sensitivity (Collins, Moore &

McQuay, 1997, Flaherty, 1996; as cited in Kahl & Cleland, 2005). The original pain

chart can still be used, but using the VAS to replace NRS. The time for requesting

additional analgesics after CTR is also recorded. The record chart is shown in

Appendix 5. Briefing for using the record chart can be done after the cold application

re-demonstrations in the training session.

The effect of the new programme can be evaluated preliminary by a working

group 1 month after the implementation. A formal evaluation can be done by holding

multi-discipline meeting 6 months and annually after the implementation. Based on

the clinical data, nurses have the rights to suggest rooms for improvement to the

programme.

3.3: Costs and benefits

3.3.1: Individual benefits and risks

For the CTS patients, the main benefit for implementing the new programme is

the decrease in pain level during CTR, and thus reduces the probability of having

respiratory and cardiovascular complications (Gorji et al., 2014; Kol et al., 2013).

Moreover, panadol as a less potent analgesic together with the cold application can

38

replace the use of more potent analgesics such as morphine and cause less

vulnerability to CTS patients (Gorji et al., 2014).

The risks for patients to receive this new programme are relatively low. The

panadol administered is 1 gram per time every 6 hours, which will not exceed the

maximum dosage for an adult per day and causes liver damage. Nevertheless, the cold

application may cause discomfort for those who are oversensitive to cold (Gorji et al.,

2014). Otherwise, this new programme is overall safe for CTS patients.

For the nurses, the preparations for cold application are mainly the source of

increased workload. Nevertheless, nurses can gain job satisfaction form this new

programme since patients are more willing to establish a rapport relationship with

them. Patients think that their nurses concern their pain and enhance them to work

together in recovery phases.

The bed statistics is around 45 or above per day in the target ward, in which CTS

patients occupy 6 beds in maximum. There are around 7-8 nurses per shift. The most

senior nurse is the in-charge nurse (IC). There are 4 cubicle IC nurses being assigned

to care patients. The 2 cubicle IC nurses, each care 10 patients in maximum while the

other 2 cubicle IC nurses care the remaining patients evenly. Other nurses are runners

to assist the cubicle IC nurses. To share the increased workload evenly among them,

CTS patients can be evenly distributed to those 2 cubicle IC nurses who are

39

responsible for lesser patients and change the cubicle IC nurses regularly after a PA

shift.

For the doctors, the new programme implemented can relieve the pain level

suffered by the CTS patients. Patients are more willing to have early ambulation after

CTR and thus reduce the chance of having respiratory complications like atelectasis

(Kol et al., 2013).

Nevertheless, doctors need to spend time to wait for the preparations before CTR,

which only take few minutes for them to perform the procedure in the past. Their

daily work maybe interfered. This problem can be solved with the following

management. For example, if 2 patients are planned to have CTR after morning round,

doctors can prescribe panadol in the medication chart and phone contact the nurses 1

hour prior they come so that the nurses have enough time to administer medication

and perform cold application to the patients. The preparations for the second patients

can be applied 5 minutes later than the first one so that doctors can perform CTR

consecutively one by one. Therefore, doctors do not need to spend time for waiting

but perform their daily works as usual.

3.3.2: Material costs of the institution

Firstly, the set-up cost for this new programme will be the time for training. A

senior physiotherapist will be invited to spend total 3 hours for demonstration while

40

24 nurses use total 24 hours to attend the training sessions. One solution to

compensate for the nurses is to mark the additional working hours in the overtime

record and allow them to leave early from work in later time.

Besides, the equipments required for this new programme are silica gel cold

packs, a refrigerator with a digital sensor keeping temperature at +4°C to store the

cold packs, dressing pads, mefix and hourmeters. These materials are originally

present in the ward for febrile patients and for daily wound dressings. Therefore, no

set-up costs will be needed for these materials but only small amount of budgets are

needed for operational costs.

Finally, there are potential reductions in using analgesics and antibiotics due to

decrease in pain and respiratory distress complications after implementation of this

new programme. Patients are more willing to perform deep breathing and ambulatory

exercises after CTR and may decrease the use of these drugs (Kol, et al., 2013). The

length of stay in hospital can also be reduced.

After calculating the above costs and benefits, the potential budgets saving for

implementing this new programme is $1901848 per year. Detailed information can

refer to Appendix 6.

3.3.3: Non-material costs of the institution

The cold application may collide with other medical activities in using the

41

treatment room. Therefore, it can be applied at patient’s bedside for 20 minutes and

perform the CTR procedure in the treatment room. This arrangement can minimize

the inconvenience.

This new programme enhances the multi-discipline co-operations. Morale among

the health care staffs will be increased since their efforts are being affirmed by their

patients. Health care projects involved multi-disciplines can be promoted to provide

good quality of care to the patients in the future.

3.4: Evidence-based practice guideline

After assessing the transferability, feasibility and costs over benefits ratio of cold

application programme as mentioned in the literatures, basically it is applicable in

local setting. An evidence based guideline that meets the local needs should be

developed to guide the implementation.

3.4.1: Guideline title

Cold application programme in reducing procedural pain due to CTR

3.4.2: Objectives

The aim of this guideline is to relieve the procedural pain suffered by the CTS

patients during CTR. The guideline can help:

1: pick up appropriate CTS patients who are going to undergo CTR,

2: standardize the pain relief preparations before CTR,

42

3: serve as a revision material for those new comers who are not familiar CTR pain

control.

3.4.3: Target populations

This guideline is intended to all the nurses who are going to provide pain relief

preparations for the CTS patients before CTR procedure in a local postoperative

surgical unit. The inclusion and exclusion criteria of the patients are shown below.

Inclusion criteria:

1: Patients with ages 20 or above.

2: Patients oriented to time, place and person.

3: CTS patients with at least one chest tube or above undergoing CTR.

4: Able to understand and rate pain level by using VAS.

Exclusion criteria:

1: Patients who are having psychiatric diseases or dementia.

2: Patients who are having poor visual acuity or blinded.

3: Patients who are oversensitive to cold and allergic to panadol.

3.4.4: Evidence based recommendations

After summarizing and synthesizing the literatures included in Chapter 2 and

other related articles, some of the statements are extracted. The levels of evidence and

grades of recommendations for these statements are determined according to Scottish

43

Intercollegiate Guidelines Network (SIGN) (2012), which is shown in Appendix 7.

The statements are shown below:

(1): VAS is an appropriate tool for assessing patient’s pain level during CTR. (Grade

of recommendation: B)

(2): Cold application together with less potent analgesics can effectively reduce CTR

procedural pain suffered by the patients. (Grade of recommendation: A)

(3): Silica gel cold packs are more effective in providing cooling effect than ice packs.

(Grade of recommendation: A)

(4): The duration for cold application and temperature should be 20 minutes and

around 0-5°C in order to provide adequate analgesic effects to the patients. (Grade of

recommendation: A)

(5): The analgesic effects of cold application can be evaluated by VAS and mean

length of time before patients request for additional analgesics after CTR. (Grade of

recommendation: A)

The detailed evidence of the statements and operational checklist are provided in

Appendix 8 and 9 respectively.

44

Chapter 4: Implementation plan

The transferability, feasibility and costs and benefits of cold application

programme have been analysed and being shown to have potential in local setting.

Nevertheless, it is still questionable whether the programme can be easily adopted and

complied by the nurses. Therefore, in this chapter, strategies to strengthen the

compliance and sustainability of the programme will be discussed.

4.1: Communication plan--- An overview

The communication and evaluation processes for implementing the programme

consist of 4 phases. The first phase is to introduce the involved parties about the cold

application programme. The second phase focuses on forming a work group to refine

and promote the programme. The third phase is to perform a pilot study to examine

feasibility. The fourth phase is to evaluate data from the pilot study to revise the

programme. Detailed timeline is shown in Appendix 10.

4.1.1: Stakeholders identification

To implement a new programme, it is crucial to identify those stakeholders who

are affected by the new practice or the results caused by that innovation. The

Programme Coordinator (PC) can have a better understanding about the influences of

the new programme to different parties and help convince them to adopt it (Grol &

Grimshaw, 2003). The stakeholders are:

45

1: Programme Coordinator (PC), i.e. the author, who is responsible to review the

clinical evidences from literatures and analysed them systematically, disseminate the

clinical findings to different parties and coordinate them to implement changes.

2: Departmental operational administers or budget holders including the Consultant

(Cons) of CTS, the Departmental Operation Manager (DOM) and the Ward Manager

(WM).

3: Senior leaders who have rich experience in their working fields and act as opinion

providers in daily practice. For example, the CTS Assisted Consultant (AC), the CTS

Medical Officers (MO) and the 4 Advanced Practitioner Nurses (APN).

4: Frontline staffs. The 21 registered nurses (RN) are responsible to implement the

programme.

5: Cold application trainer, i.e. the senior physiotherapist.

6: CTS patients who are undergoing CTR.

4.1.2: Forming a working group

To implement a new programme, the PC should first gain support from the

colleagues. It is not easy to implement a change even it is developed according to

evidence. Marketing theories suggested that the targeted stakeholders should receive

clear and attractive messages in order to perform a change (Grol & Grimshaw, 2003).

Therefore, after reviewing the literatures, the PC can grab the chance to present the

46

basic idea of cold application programme among the nurses during ward meeting. The

presentation contents include the inadequacy of pain control for CTS patients during

CTR, the benefits of applying cold application programme for pain control and the

transferability and feasibility of applying it in local setting. Lastly, a brief introduction

of the clinical protocol can be delivered to them. After the meeting, the issue of pain

control among CTS patients during CTR can be raised among the nurses, which can

initiate them to ask questions regarding to the implementation and more likely for

them to support the new practice.

Secondly, WM can help report this proposal to DOM and Cons of CTS

department to seek approval and resources allocation. After gaining approval, a

working group can be formed. The working group includes WM, 1 AC and 1 MO of

CTS department, 4 APN, 1 senior physiotherapist, PC, and 3 Registered Nurses (RN)

who have shown interests to the new programme during ward meeting.

4.1.3: Roles of working group

There is a division of labor within the working group. The WM can help arrange

duties to facilitate nurses to attend the training sessions. Besides, the WM can invite a

senior physiotherapist as a cold application trainer and allocate resources for the

programme.

According to social influence theory, the presence of senior leader can act as a

47

role model to a new practice so that other staffs will obey and follow it (Grol &

Grimshaw, 2003). Therefore, the senior leaders in the working group can help

influence and motivate other staffs to implement the programme. Besides, the senior

leaders can offer some opinions based on their experiences to modify the clinical

protocol to make it more feasible to be implemented.

The senior physiotherapist acts as a cold application trainer to train nurses for

cold application techniques.

The PC and the 3 RN are responsible to create a folder related to cold application

programme. The clinical protocol will be attached in this folder and being placed near

the nursing station so that other nurses can easily access and have a quick reference

for the procedures. In addition, posters will be designed and the programme details

will be sent via intranet email in order to let nurses keep update about the programme.

The PC and the 3 RN will apply their learnt cold application techniques in the pilot

study to examine the feasibility of the programme.

Lastly, the sustainability of the programme is a major concern. According to Grol

& Grimshaw (2003), staff compliance to a new programme determined by several

factors, which are the compatibility of the proposed changes to the prevailing

philosophy in local setting, procedures’ complexity, new skills required and the

clinical outcomes.

48

In view of these factors, a meeting can be held between the working group and

nurses 1 month after the pilot study. The working group members can share the results

of the pilot study, including the difficulties and feasibility when implementing the

programme, with other nurses to seek for their opinions. They can also reassure other

nurses that the resources needed for the programme were already exist and the new

skills required are only the cold application techniques. Adequate training sessions

will be provided to the nurses to clarify questions before implementation. Besides, the

working group can announce that the programme will be fully implemented after the

training sessions and welcome other nurses to seek help from them when encounter

any difficulties. These arrangements can enhance nurses’ acceptance to the

programme.

Patient’s pain level in terms of VAS can be collected by the working group and

discussed with other nurses during ward meeting 1 month and 6 months after full

implementation and the annual departmental Kaizen meeting. With these successful

stories, nurses are inspired and more likely to participate actively to the programme

(Grol & Grimshaw, 2003).

4.2: Pilot study

The purpose of conducting pilot study is to apply the new practice into smaller

sample to examine the feasibility before full implementation (Leon, Davis & Kraemer,

49

2011). The contents include patient’s recruitment, communication processes between

various members and barriers noticed during implementation. Through evaluations,

revisions can be done to the progamme before it is largely applied to a clinical unit

(Leon et al., 2011).

4.2.1: Patient’s recruitment

According to past records, around 4 CTS patients underwent CTR per week.

Therefore, 8 CTS patients who are eligible as mentioned in the clinical protocol will

be selected over 2 weeks. The selected patients will be arranged to two groups evenly,

which are cold application (intervention) and control groups. Once they are selected,

the working group will approach them and explain clearly about the benefits and risks

of joining the study and obtain a written consent at that time.

4.2.2: Rundown testing

Several items can be tested during the pilot study. Firstly, the PC and 1 RN in the

working group will be the responsible nurses for the intervention group. They will be

assigned as the cubicle IC in a cubicle (maximum patients = 10). The cubicle IC is

responsible to check the CTR order from the kardex after morning round and

administer 1 gram panadol to the patient 1 hour before CTR and round the clock

every 6 hours. Besides, a silica gel cold pack of +4°C will be applied by the cubicle IC

around the chest tube at bedside for 20 minutes before CTR. Then the patient will be

50

transported to the treatment room and the cubicle IC will assist the CTS MO to

perform CTR. For the control group, the other 2 RN in the working group will be

arranged as the cubicle IC and repeat the same procedures except cold application.

These arrangements can examine whether a trained nurse can bear the increased

workload due to the new programme.

Besides, the CTS MO should inform the coming time to the responsible nurses

for CTR. This is crucial if there are 2 or more selected patients need to undergo CTR,

so that the nurses can gain enough time for preparations. The adequacy of

communications between the medical professionals can then be examined.

Lastly, the responsible nurses will assess patient’s pain level in terms of VAS by using

the pain chart before and after CTR. The data recorded will be documented in the

progress notes as shown in Appendix 11 or 12. Through the assessments, comments of

the programme by patients can be received. Besides, the difficulties in pain level

assessments and nurses’ documentations can also be identified.

The senior leaders in the working group are responsible to supervise and monitor

the whole implementation processes and provide opinions during evaluations.

4.2.3: Pilot study evaluations:

The results of the pilot study can be evaluated by the working group by holding a

meeting 1 week later. Several issues, such as patient’s comments to the programme,

51

concerns about the increased workload for the nurses and resources arrangement can

be discussed. These evaluations can help refine the programme before it is fully

implemented.

4.3: Evaluation plan

Although the cold application programme will be fully implemented after the

pilot study, regular evaluations are needed to monitor the progress and measure

clinical outcomes. These evaluations can help the programme become more effective

and safe for practice in the future (Grol & Grimshaw, 2003). Therefore, the

programme is designed to evaluate 1 month, 6 months and annually after full

implementation.

4.3.1: Patient outcomes

Patient outcomes are defined as clinical benefits received by the patients after

receiving the treatment. The primary patient outcomes for the cold application

programme are the mean pain level reduction of the intervention group immediately

and 15 minutes after CTR when compared with the control group. The formulas are

shown below:

Mean VAS(inter imm) – Mean VAS(cont imm) = Mean VAS(pain reduce imm)

Mean VAS(inter 15mins) – Mean VAS(cont 15mins) = Mean VAS(pain reduce 15mins)

(inter imm = intervention group immediately after CTR; cont imm = control group immediately after

52

CTR; inter 15mins = intervention group 15 minutes after CTR; cont 15 minutes = control group 15

minutes after CTR; pain reduce immed = pain reduction immediately after CTR; pain reduce 15mins =

pain reduction 15 minutes after CTR)

The pain level is measured using VAS. It provides a continuum for patients to

rate their pain and easily understood by them. Therefore, it is a tool with high

reliability and validity (Bijur, Latimer & Gallagher, 2003; Tamiya et al., 2002;

Williams, Davies & Chadury, 2000).

The secondary outcome for this programme is to determine the mean length of

time for requesting additional analgesics by both groups after CTR. In Demir &

Khorshid (2010) study, the difference in mean length of time between two groups

were significant (p<0.05), which can act as an indicator for patient outcome.

4.3.2: Healthcare provider outcomes

Healthcare provider support is a major element to sustain the programme. This

support includes the acceptance and competence of implementing cold application

programme by the nurses. These components can be assessed by delivering self

reporting questionnaires to the nurses during regular meetings and reviewing the

completeness and integrity of the documentations by the nurses.

4.3.3: System outcomes

Measuring system outcomes is important since it reflects the overall worthiness

53

of the programme. Several issues such as programme utilization, manpower

requirement and programme running cost will be addressed. The programme

utilization can be assessed by evaluating total number of CTS patients received the

programme before CTR annually. The manpower requirement depends on the

programme utilization annually. The programme running costs include the costs for

training sessions and paper printings are calculated annually in order to determine the

budgets.

4.3.4: Data measurements and analysis

4.3.4.1: Patient outcomes

Convenient sampling is used to select eligible CTS patients which based on the

inclusion criteria as mentioned in clinical protocol. The pain level of these patients are

recorded in pain chart and documented in progress notes as shown in Appendix 11 or

12.

When considering the primary outcomes, the mean pain level reduction before

and after CTR between two groups are analyzed using two-tailed independent

samples t-test. The sample size is determined using a sample size calculator created

by Lenth (Lenth, 2011).

Two null hypotheses are presented. The first one is the mean VAS immediately

after CTR are equal for both groups. The second one is the mean VAS 15 minutes

54

after CTR are equal for both groups.

When considering the first null hypothesis, according to the literatures, the mean

reduction in VAS in intervention group when compared with control group ranged

from 10% to 50%, with standard deviations (SD) around 59% for intervention group

and 54% for control group (Demir & Khorshid, 2010; Gorji & Nesami, 2014;

Mazloum et al., 2012). Take type 1 error = 5%, power = 80% and a modest pain level

reduction = 30%, total 114 patients are needed. If 10% drop out rate is estimated, 127

patients should be recruited.

When considering the second null hypothesis, according to the literatures, the

mean reduction in VAS in intervention group when compared with the control group

ranged from 25% to 65%, with SD around 52% for intervention group and 70% for

control group (Demir & Khorshid, 2010; Gorji & Nesami, 2014; Mazloum et al.,

2012). Take type 1 error = 5%, power = 80% and a modest pain level reduction = 40%,

total 76 patients are needed. If 10% drop out rate is estimated, 85 patients should be

recruited.

To demonstrate two effects, 127 patients should be recruited. According to the

past records, around 204 CTS patients underwent CTR annually. Therefore, recruiting

127 patients is reasonable.

When considering the secondary outcome, the time for requesting additional

55

analgesics are recorded in pain chart and progress notes. Kaplan Meier analysis can be

applied to estimate a 95% confidence interval for the mean length of time after CTR

for both groups.

4.3.4.2: Healthcare provider outcomes

The qualitative indicators for health care provider outcomes are self acceptance

and competence of implementing the programme. Questionnaires will be delivered

during evaluation meetings to collect nurses’ opinions about the programme and

assess their morale. The senior leaders in the working group will review nurses’

documentations to determine its completeness and integrity each month. If problems

are detected, they will clarify with nurses during regular ward meetings every 3

months.

4.3.4.3: System outcomes

The results of system outcomes reflect the programme utilization rate and thus

affect the manpower arrangement and budgets being spent to the programme. Once

patients have joined the programme, the PC records them in nursing summary of the

Clinical Management System monthly. The PC is responsible to write a report by

listing the number of patients received the treatment and expenses spent annually.

This report will be handed in and evaluated by the working group members annually.

4.4: Basis for implementation

56

The cold application programme is defined as success if the two-tailed

independent samples t-test show the mean pain level immediately and 15 minutes

after CTR in intervention group are significantly lower than the control group, i.e.,

with p < 0.05.

Conclusion

Cold application together with less potent analgesics (Panadol) has been shown

to be effective in reducing CTR procedural pain for CTS patients. Cold application

reduces the use of potent traditional analgesics that may bring out worse

complications to the patients. Besides, when compared between the literature and

local settings, cold application is feasible to be implemented in local CTS units. The

development of evidence based nurse-led CTR clinical protocol allows nurses to

select appropriate CTS patients and prepare the CTR procedure in a standardized way.

Last but not least, a well established evaluation plan is proposed to help identify the

clinical outcomes, which can help refine the programme and sustain it in the future.

By implementing this programme, it is hope that a rapport relationship can be built

between the nurses and patients and enhance them to work together in recovery

process.

Reference

1: Barber, F.A., McGuire, D.A., & Click, S. (1998). Continuous-flow cold therapy for

57

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Related Surgery, 14(2), 130-135.

2: Williams, A.C.de C., Davies, H.T.O., & Chadury, Y. (2000). Simple pain rating

scales hide complex idiosyncratic meanings. Pain, 85, 457-463.

3: Sauls, J. (2002). The use of ice for pain associated with chest tube removal. Pain

Management Nursing, 3(2), 44-52.

4: Tamiya, N., Araki, S., Ohi, G., Inagaki, K., Urano, N., Hirano, W., & Daltroy, L.H.

(2002). Assessment of pain, depression, and anxiety by visual analogue scale in

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5: Bijur, P.E., Latimer, C.T., & Gallagher, E.J. (2003). Validation of a verbally

administered numerical rating scale of acute pain for use in the emergency department.

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6: Grol, R., & Grimshaw, J. (2003). From best evidence to best practice: effective

implementation of change in patients’ care. The Lancet, 362, 1225-1230.

7: Sarifakioglu, N., & Sarifakioglu, E. (2004). Evaluating the effects of ice application

on the pain felt during botulinum toxin type-A injections: a prospective, randomized,

single-blind controlled trial. Annals of Plastic Surgery, 53, 543-546.

8: Kahl, C., & Cleland, J.A. (2005). Visual analogue scale, numeric pain rating scale

and the McGill pain questionnaire: an overview of psychometric properties. Physical

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acute ankle sprains: a randomized controlled study of two different icing protocols. Br

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reduction of postoperative pain: prospective randomized study. Hernia, 10, 184-186.

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Hospital Authority.

12: Zahra, A., Rigi Sh.d., N., Salmeh, D., & H.A. E. (2008). Comparing the effect of

cooling gel pads and ice pack, after episiotomy on the intensity of perineal pain.

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13: Alanen S., Valimaki, M., Kaila, M., & ECCE study group. (2009). Nurses’

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14: Moher, D., Liberati, A., Altman, DG., & The PRISMA Group (2009). Preferred

Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement.

PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097.

15: Demir, Y., & Khorshid, L. (2010). The effect of cold application in combination

with standard analgesic administration on pain and anxiety during chest tube removal:

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a single-blinded, randomized, double-controlled study. Pain Management Nursing,

11(3), 186-196.

16: New Territories West Cluster. (2010). Department of Surgery statistics in Tuen

Mun Hospital. Hong Kong: Author. Retrieved November, 16, 2014, from

http://ntwc.home/surg/department.asp?p=0

17: Ertug, N., & Ulker, S. (2011). The effect of cold application on pain due to chest

tube removal. Journal of Clinical Nursing, 21, 784-790.

18: Leon, A., Davis, L.L., & Kraemer, H.C. (2011). The role and interpretation of

pilot studies in clinical research. J Psychiatr Res., 45(5), 626-629.

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May 5, 2015 from http://www.cs.uiowa.edu/~rlenth/Power/.

20: Hospital Authority. (2012). Press Releases: Service costs of Hospital Authority.

Hong Kong: Author. Retrieved December 1, 2014, from

http://www.info.gov.hk/gia/general/201205/09/P201205090336.htm

21: Mazloum, S.R., Abbasi, T.M., Kianinejad, A., & Gandomkar, F. (2012). Effect of

applying icie bag on pain intensity associated with chest tube removal after cardiac

surgery. Quarterly of Ofoghe Danesh, 18(3), 109-114.

22: Scottish Intercollegiate Guidelines Network. (2012). SIGN 50: A guideline

developer’s handbook. Scotland: Author. Retrieved December 1, 2014, from

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http://www.sign.ac.uk/guidelines/fulltext/50/annexoldb.html

23: Kol, E., Erdogan, A., Karsh, B., & Erbil, N. (2013). Evaluation of the outcomes of

ice application for the control of pain associated with chest tube irritation. Pain

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& Rana, M. (2013). Three-dimensional evaluation of postoperative swelling in

treatment of zygomatic bone fractures using two different cooling therapy methods: a

randomized, observer-blind, prospective study. Trials, 14(238), 1-10.

25: Otaibi, R.A.A., Mokabel, F.M., & Ghuneimy, Y.A. (2013). The effect of cold

application on pain and anxiety during chest tube removal. Journal of American

Science, 9(7), 13-23.

26: Scottish Intercollegiate Guidelines Network (2013). Randomised controlled trials

checklist. Scotland: Author. Retrieved April 14, 2014, from

http://www.sign.ac.uk/methodology/checklists.html

27: Gorji, M.H., Nesami, M, B., Ayyasi, M., Ghafari, R., & Yazdani, J. (2014).

Comparison of ice packs application and relaxation therapy in pain reduction during

chest tube removal following cardiac surgery. North American Journal of Medical

Sciences, 6(1), 19-24.

28: Mitra, P.B., Nahid, D., Nouraddin, M., & Eskandar, N. (2014). Effect of cold

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application in combination with indomethacin suppository on chest tube removal pain

in patients undergoing open heart surgery. Iranian Journal of Nursing and Midwifery

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Hospital. Hong Kong: Hospital Authority.

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Appendix 1: Search history (PRISMA Flow Diagram)

Identification

Literatures identified through database searching

(n = 13)

Additional literatures identified through other sources

(n = 1)

Literatures after duplicates removed (n = 7)

Screening

Literatures screened (n = 7)

Literatures excluded (n = 0)

Eligibility

Full-text articles assessed for eligibility

(n = 7)

Full-text articles excluded, with reasons

(n = 0) Included

Studies included in qualitative synthesis

(n = 0)

Studies included in quantitative synthesis

(meta-analysis) (n = 7)

63

Appendix 2: Table of evidence Bibliographic citation

Study type

Patient characteristics

Intervention(s) Comparison Length of FU

Outcome measures Effect size Mean(IG – CG)

Sauls, 2002

RCT

study

-Cardiac patients in 2 ICU

and 3 postoperative units

with chest tubes inserted

-Ages: 21-85 years old

(Mean ages: 59.7 years

old)

Ice pack was applied to the

skin at either side of the chest

tubes, covering 38.7 cm² for

10 minutes

(n=25)

Tap water pack (30.6°C to

31.7°C) was applied to the

skin at either side of the chest

tubes, covering 38.7 cm² for

10 minutes

(n=25)

Not

mentioned

Primary:

(1) Pain & Distress in NRS:

(A) immediately after CTR

(B)10 minutes after CTR

(2) No. of quality descriptors

for pain

Secondary:

(3) Pain & Distress in NRS

10mins after packs application

(1) (A):

Pain: -0.48 (p>0.05)

Distress: +0.42 (p>0.05)

(1) (B):

Pain: -0.26 (p>0.05)

Distress: -0.1 (p>0.05)

(2) Both groups: 15

(3)Pain: +0.14 (p>0.05)

Distress: -0.1 (p>0.05)

Demir, 2010 RCT

study

-Cardiac patients in ICU

with 2-3 chest tubes

inserted

-Ages: 18-74 years old

(Mean ages: 53.4 years

old), BMI<30kg/m²

-10mg/kg paracetamol IV

was injected 60 minutes

before CTR (for all groups)

- A gel pack (+4°C) was

placed to the skin occupying

5cm³ surrounding chest tubes

for 20 minutes

(n=30)

Two comparison groups

(a) & (b):

(a) A gel pack (room

temperature) was placed to

the skin occupy 5cm³

surrounding chest tubes for

20 minutes (n=30)

(b) Nil packs being applied

(n=30)

Not

mentioned

Primary:

(1) Pain in VAS:

(A) immediately after CTR

(B) 15 minutes after CTR

(2) Anxiety score difference

(STAI-I) 15 minutes after CTR

Secondary:

(3) length of time (hours)

before requesting analgesics

after CTR

(1)(A)(a): -0.36 (in sig.)

(1)(A)(b): -0.46 (in sig.)

(1)(B)(a): -0.7 (in sig.)

(1)(B)(b): -0.7 (in sig.)

(2)(a): -3.21 (p>0.05)

(2)(b): -4.4 (p>0.05)

(3)(a): +0.3 (p<0.05)

(3)(b): +0.43 (p<0.05)

64

Bibliographic citation

Study type

Patient characteristics

Intervention(s) Comparison Length of FU

Outcome measures Effect size Mean(IG – CG)

Ertug, 2011

CT

study

-Thoracic surgery patients

in postoperative surgical

clinic with 1 chest tube

inserted

-Did not have CTR

experience

-Ages:18-65 years old

(Mean ages: 48.7 years

old)

-Ice pack covered 6.125 cm²

skin around the chest tube

before CTR

-Pack removed when reached

13°C (average time: 9 mins)

(n=70)

No ice pack application

before CTR

(n=70)

Not

mentioned

Primary:

(1) Pain in VAS:

(A) immediately after CTR

(B) 5 minutes after CTR

Secondary:

(2) 4 time points temperature

around the skin of the chest

tube in intervention group

(1)(A) -1.75 (p<0.05)

(1)(B) -0.38 (p<0.05)

(2)

1st data: 33.13°C

2nd data: 12.93°C

3rd data: 23.58°C

4th data: 29.59°C

(p<0.05)

Mazloum, 2012 RCT

study

-Cardiac patients in ICU

with 1 pericardial and 1

thoracic chest tube.

-Distance between the

tubes: 8-10cm.

-Mean ages: 56 years old.

Mean BMI: 25kg/m²

-Midazolam IV was given (for

all groups)

-Ice packs (0 -5°C) were bent

in half circle shape and being

applied around the skin of the

chest tube for 20 minutes

(n=34)

Comparison groups (a)&(b):

(a) Placebo packs

(18-22°C) were bent in half

circle shape and being

applied around the skin of the

chest tube for 20 minutes

(n=34)

(b) Nil packs being applied

(n=34)

Not

mentioned

Primary:

Pain in VAS:

(A) immediately after CTR

(B) 15 minutes after CTR

(A)(a) -1.7 (p<0.05)

(A)(b) -1.5 (p<0.05)

(B)(a) -1.4 (p<0.05)

(B)(b) -1.3 (p<0.05)

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Bibliographic citation

Study type

Patient characteristics Intervention(s) Comparison Length of FU

Outcome measures Effect size Mean(IG – CG)

Otaibi, 2013 RCT

study

-CTS patients in surgical ward

and ICU with 1 or 2

mediastinal or pleural chest

tubes.

-Mean ages: 40.7 years old

-1gram perfalgan received 60

minutes before CTR (for all

groups)

-A soft ice gel pack was placed

around the skin of the chest

tube

-Gel pack removed when

reached 13°C

(n=20)

Placebo pack (room

temperature) being

applied (n=20)

Not

mentioned

Primary:

(A) Pain in VAS:

(B) Immediately after CTR

(C) 15 minutes after CTR

(2) HAM-A changes after CTR

Secondary:

(3) Correlation: Pre-CTR

anxiety VS pain level

15minutes after CTR

(4) Demographic

characteristics VS pain level

(1)(A) -5.95 (p<0.05)

(1)(B) -1.8 (p<0.05)

(2) -5.55 (in sig.)

(3) +0.0364 (p<0.05)

(4) Pain level:

-before CTR: p<0.05

–during CTR: p>0.05

-15 minutes after CTR:

p>0.05

Gorji, 2014 RCT

study

-Open heart CABG patients in

CCU with 1 left pleural and 1

mediastinal chest tubes

-Did not have CTR experience

-Mean BMI: 25.8kg/m². Mean

ages: 58.1 years old

-Acetaminophen pills received

every 6 hours (for all groups)

-3 cold gel packs (0°C) twisted

by gauze were placed to skin

surrounding chest tubes

-Packs removed when reached

13°C (mean time: 10 minutes)

(n=40)

Nil gel packs being

applied

(n=40)

Not

mentioned

Primary:

Pain in VAS:

(A) immediately after CTR

(B) 15 minutes after CTR

(A) -2.2 (p<0.05)

(B) -0.22 (p<0.05)

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Bibliographic citation

Study type

Patient characteristics Intervention(s) Comparison Length of FU

Outcome measures Effect size Mean(IG – CG)

Mitra, 2014 RCT

study

-CABG or CABG with

valvular surgery patients in

ICU with pleural and

mediastinal chest tubes.

-Mean ages: 58.7 years old

-Indomethacin suppository of

dosage: 100mg received 1

hour before CTR (for all

groups)

-A cold gel pack (4 °C) was

applied to the skin

surrounding chest tube for 20

minutes before CTR

(n=32)

A gel pack (room

temperature) was applied

to the skin surrounding

chest tube for 20 minutes

before CTR

(n=34)

Not

mentioned

Primary:

Pain in VAS:

(A) Immediately after CTR

(B) 15 minutes after CTR

(A) -1.23 (p<0.05)

(B) -0.14 (p>0.05)

Abbreviations: 1: CTR= chest tube removal 6: in sig.= in significant 2: Length of FU= length of follow up, in months 7: RCT= randomised controlled trial 3: IG – CG= intervention group – comparison group 8: CCT= clinical controlled trial 4: NRS & VAS= numerical rating scale & visual analogue scale 9: HAM-A= Hamilton anxiety rating Both scales ranged from 0 to 10 scores, with 0 = the least severe, 10 =the most severe scale 5: STAI-I= Spielberger situational anxiety level inventory 10: CTS= cardiothoracic surgery (Larger negative value= more reduction in anxiety level)

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Appendix 3: Methodology checklist (Based on SIGN checklist related to controlled trials)

Sauls, 2002 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those aged from 21-85 years old with chest tubes inserted after cardiac surgery. In the intervention group, ice pack was placed at either side of the chest tube’s skin for 10 minutes before CTR. The comparison group was the application of tap water pack for 10 minutes before CTR. The primary outcomes of the study were the pain level and pain distress immediately and 10 minutes after CTR. The number of quality descriptors used for pain after CTR was another primary outcome. The secondary outcomes of this study were the pain and distress level 10 minutes after the application of packs before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The Author only stated that the participants were randomly assigned into intervention and control groups, but did not mention the randomization method in details. 1.3: An adequate concealment method is used. Answer: No. There was no mention for the concealment methods for the researchers when assigning participants into groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Can’t say. As the presence of blinding for patients and investigators were not clearly mentioned.

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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author stated that the demographic data of the participants such as the age, gender, ethnicity, primary diagnosis, type and number of chest tubes, previous cardiac surgery and previous chest tubes experience and type of postoperative pain medication were collected and mentioned that there were no significant differences between the intervention and comparison groups. However, the actual data for these demographic variables had not been listed in the article. 1.6: The only difference between groups is the treatment under investigation. Answer: No. As mentioned by the author, the investigator, which was the only nurse present during the intervention, might provided a chance for some of the participants to ask questions related to the treatment received. It was difficult for the investigator not to respond to their questions and extra information and explanations were provided by the investigator to some of the participants. Also, seven health care professionals with different level of expertise performed the CTR, the environmental nature of different sites might create extraneous variables for the participants. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this article based on primary outcomes. The primary outcomes of the study were to see whether the application of ice pack around the chest tubes for 10 minutes can significantly decreased the pain level and pain distress of the patients immediately and 10 minutes after CTR. Another primary outcome was to see whether fewer quality descriptors for pain would be used in the intervention group than the comparison group after CTR. The measurement tool for pain level and pain distress was numeric rating scale (NRS), which was supported by Puntillo (1994, 1996) & Puntillo & Weiss (1994), to effectively rate the procedural pain and distress of critically ill patients. The presence of reliability and construct validity for this NRS had also been supported by Downie et al. (1978), Jensen, Karoly & Braver (1986), Jensen, Karoly, O’Riordan, Bland & Burns (1989). The quality descriptors for pain listed in the McGill Pain Questionnaire-Short Form (MPQ-SF) were used. The presence of reliability and validity for MPQ-SF had been supported by Chapman et al. (1985), Wilke, Savedra, Holzemer, Tesler & Paul (1990).

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1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out from both intervention and control groups after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in both intervention and control groups completed the treatments assigned to them. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. As the study carried out at different units (a surgical intensive care unit, a coronary intensive care unit, a medical intensive care unit and 2 acute postoperative units) in a teaching hospital, there were no reports given for the specific data of these sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated unacceptable (reject 0). The main problem for this study was that the difference between the intervention and control groups was not only the treatments, but also the extra explanations and information provided by the investigator which might create some extraneous variables to the results. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It is not certain that the overall effect was due to the intervention. According to the results, there were no significant difference between the intervention and the control groups in pain level, distress level and the number of quality descriptors used for pain. From the methodological

70

aspect, the randomization method, the concealment method, the blinding method and the results for the specific site should be elaborated and reported in details. The major confounding variables should be the treatments offered to both the intervention and control groups. The inconsistency of the environment for different sites, the different expertise level of health care professionals in performing CTR and the extra information and explanations provided by the investigator for some of the participants might affected the final results. For the statistical power of the sample, there was nil information being mentioned. However, in view of 25 participants for both groups yielded non-significant difference results, sample size should be increased for future study to improve the statistical power. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The study intervention can be directly applied to the patients, as cold application method is cheap, safe to patients and easy to be applied. However, in view of the insignificant difference results between the intervention and control groups, it may not be considered by the health care professionals to implement this intervention. 2.4: Conclusion and comment for this article: According to the Author, pain consisted of distress component (affective) and sensory pain and they are correlated. Similar study should be done in the future, in which the ice pack application could be longer than 10 minutes to produce a desire effect, a larger sample sized is needed, dividing participants into 3 groups which contained intervention group, placebo group and those undergo usual treatment to rule out whether there were any effects for the placebo treatment. In the article, the tap water at the range of 30.6°C to 31.7°C might achieve some kind of cooling effect to the skin temperature in the control group, which might contribute to the non-significant difference results between the intervention and control groups. Furthermore, an effort to control extraneous variables, better randomization, concealment and blinding methods should be elaborated clearly in the future study to improve generalizability.

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Demir, 2010 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The targeted patients in this study were those cardiac surgery patients aged 18-74 years old, BMI<30kg/m² and with 2 to 3 chest tubes inserted after operations in ICU. A standard dose of 10mg/kg paracetamol IV would be injected to all participants 60 minutes before CTR. For the intervention group, a cold gel pack (+4°C) wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. There were two comparison groups, the placebo and control groups. For the placebo group, a gel pack at room temperature wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. For the control group, nil gel pack would be applied. The primary outcomes of the study were pain intensity immediately and 15 minutes after CTR and anxiety level during CTR. The secondary outcome would be the length of time before the request for analgesics after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that a simple randomization method was used for assigning participants into groups. However, there was no mention about the randomization method in details. 1.3: An adequate concealment method is used. Answer: Can’t say. The authors only mentioned that some methods were used to prevent manipulation during assignment. However, no details about the methods were provided.

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1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, the study participants were ‘blinded’ by the researcher and did not know which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors only stated that the demographic and clinical features of the participants in the three groups were similar and no significant differences, with P>0.05. A table listing the demographic and clinical features of the participants in each group should be provided for better understanding. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The participants in each group received their treatments in standard way according to the group being assigned. All the chest tubes were removed by the same doctor. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The first primary outcome of this study was to determine whether the application of cold gel pack could significantly reduce the pain intensity immediately and 15 minutes after CTR. Another outcome was to determine whether the intervention could significantly reduce the anxiety level during CTR. The conclusions of this study based on the primary outcomes. The pain intensity was rated by vertical visual analog scale (VAS). The validity of VAS was supported by Puntillo (1994) for critically ill cardiovascular surgery patients. The anxiety level was measured by a tool called Spielberger Situational Anxiety level Inventory (STAI-I), the concurrent validity was supported by LaCompte & Oner (1976).

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1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. The participants in the groups received their treatments according to the groups being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the cardiovascular and thoracic surgical intensive care unit at Ege University Hospital. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated acceptable (+). Most of the internal validity criteria are met for this study. Single blinding method was used and the treatments received by the participants were standard according to the group being assigned. However, the randomization and concealment methods should be elaborated more for better understanding. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It is quite certain that the overall effect is due to the intervention, but improvements should be considered. The intervention group had shown a significant reduction in pain intensity immediately and 15 minutes after CTR. In addition, it showed longer time for requesting analgesics after CTR when compared with the comparison groups. When viewing the methodology used for this study, according to Sauls (2002)

74

study, the use of 30.6°C to 31.7°C placebo bag to the group might actually provide a cooling effect to the skin of the placebo group. The placebo pack used in this study was at room temperature, which might reduce the cooling effect to the placebo group. In addition, single blinded method applied to the participants could reduce the bias arise in the study. Furthermore, the demographic data for both intervention and comparison groups were similar (P>0.05), each participant received treatments according to the group being assigned in a standard way increased the rigor of the study results. The tools for measurement were reliable and valid. Only 1 doctor performed CTR also ensured the reliability of the results. However, the authors should elaborate more about the randomization and concealment methods in order to have a better understanding of the study. For the statistical power, power analysis was performed to calculate the simple size, and the power was 81% (alpha <0.05) for the sample size which was adequate to show the effects of the intervention. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The application of cold gel pack is simple, safe to patients and cheap which can be directly applied to the patients. It is worth for health care professionals to apply the intervention as this study had shown a significant reduction of pain intensity after CTR. 2.4: Conclusion and comment for this article: According to the study, the cold gel application could significantly reduce the pain intensity during CTR and prolong the time for requesting analgesics, but did not affect the anxiety level being felt by the participants. Participants’ emotions could be affected by the environment, such as the light, noise and the surrounding health care professionals. Furthermore, participants with different cultural backgrounds might affect their perceptions to pain and anxiety. Therefore, environmental factors should be well controlled by the researchers and the culture factor of the participants on pain and anxiety perception should be studied in the future research. Besides, placebo pack of temperature closed to the skin temperature of the participants should be used in order to reduce the cooling effect on the participants in the placebo group. Finally, although the cold gel application group showed a significant decrease in pain intensity during CTR, the VAS was still 6.77 immediately after CTR, which was moderate level in pain. Future studies should be consider to combine cold application method with other pharmacological methods or

75

non-pharmacological methods in order to help participants have a better pain control during CTR. Ertug, 2011 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The authors had stated the characteristics of the participants: 18-65 years old with one chest tube and did not have previous CTR experience. Intervention group: ice pack being applied around the chest tube insertion site before CTR until the skin temperature reached 13°C. Comparison group: no ice pack application before CTR. The primary outcomes: the VAS score immediately and 5 minutes after CTR and the secondary outcome: the changes in skin temperature at 4 different time points for the intervention group. 1.2: The assignment of subjects to treatment groups is randomized. Answer: No. The participants were assigned to the intervention and control groups according to the time they were recruited. The participants recruited on the odd-dated days of the month would be arranged to intervention group while those recruited on the even-dated days would be arranged to control group. This study was a clinical controlled trial study instead of randomized controlled trial study. 1.3: An adequate concealment method is used. Answer: Not relevant as it was a clinical controlled trial study. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Not relevant as it was a clinical controlled trial study.

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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had mentioned the demographic data between the intervention and the control groups. The data included genders (P>0.05), ages (P> 0.05), indications for chest tube insertion (P>0.05) and chest tube insertion days (P< 0.05). Among all the data, only the chest tube insertion days had shown a significant difference but not others. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The authors had mentioned that all the participants in the intervention group received the ice pack application while all the participants in the control group received nil treatment. Although different physicians were responsible for CTR for the participants, all the physicians followed the same guideline in performing CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes were the pain score immediately and 5 minutes after CTR. The main conclusion was based on the primary outcomes. The primary outcomes (changes in patients’ pain level) were measured using the vertical VAS. According to Guzeldemir (1995) & Eti-Aslan (2002), VAS was a sensitive and reliable tools for reflecting pain score. In addition, Cline et al. (1992) & Guzeldemir (1995) pointed out that a vertical line based VAS was easily understood by the participants. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: The authors had mentioned that there were 5 participants in the intervention group and 4 participants in the control group dropped out from the study before the research began. The drop out rate was 7.14% for the intervention group and 5.71% for the control group and such loss was replaced by recruiting other participants. However, there were no reasons provided for the drop out.

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1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. It was because all the participants in the intervention group had ice pack application before CTR and the participants in the control group had nil interventions before CTR. The chest tubes in both the intervention and control groups were removed finally. No missing values or dropped out participants noticed after the research began. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. It was because the study was carried out in a surgery clinic in a thoracic hospital but not conducted in various sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+) in general speaking. The study met most of the criteria in the checklist. However, it could not be regarded as a randomized controlled trial study as the assignment of the participants to the groups based on time of recruitment but not randomization. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the primary outcomes of the study were due to cold application, but some improvements should be considered. In view of the methodology, the pain level of the participants was measured by using VAS, which was reliable and valid as discussed before. All participants received the intervention based on their group and had CTR according to standard protocol. There was no missing data found during the study. However, the assignment of the participants should be randomized instead of determined by the time they were recruited to reduce the demographic bias of the participants between the intervention and the control groups. Lucky, the demographic data between two groups were similar except the days for chest tube insertion. In view of the statistical power of the study, the sample size 140 was adequate since the power

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was calculated as 99%, which was greater than 0.8, for alpha=0.05, as this study contained 2 independent groups. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: This method was cheap, safe and easy to be applied. Therefore, cold application should be considered applying directly to the target patients. The cold application could significantly reduce the pain intensity of the participants immediately and 5 minutes after CTR in this study, which worth to be considered by the health care professionals. 2.4 Conclusion and comment for this article: According to the study, cold application as a non-pharmacological method applied prior to CTR could reduce the pain level immediately and 5 minutes after CTR. In this study, it supported the study result of Demir & Khorshid (2010), which shown a significant decreased in pain level for cold application group after CTR, but contradict with the study result found in Sauls (2002), which showed that cold application was not effective in reducing pain related to CTR. Moreover, this study only employed those with only 1 chest tube, which could not concluded the pain intensity experienced by those with 2 or more chest tubes. Therefore, further studies with a good randomization and concealment methods, larger sample size and recruited those with 2 or more chest tubes in order to increase the generalizability of the result. Mazloum, 2012 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those underwent cardiac surgery with mean ages 56 years old, mean BMI=25kg/m² and had one pericardial and one thoracic chest tubes. Participants in both groups had been prescribed midazolam IV before CTR.

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In the intervention group, ice packs of temperature 0-5°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. There were 2 comparison groups, which were the placebo and the control groups. In the placebo group, packs of temperature 18-22°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. For the control group, no packs would be applied before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The authors stated that the assignment of participants to the groups was randomized. This was a crossover study in which each chest tube in each patient would be assigned for 1 treatment. There were 3 groups in this study, which were the cold application-control group, the cold application-placebo group and the placebo-control group. 3 cards with codes for these 3 groups would be drawn out by the researchers randomly. For example, if a card coded for cold application-control group was drawn, one chest tube would receive ice pack treatment while the other chest tube would not receive any packs for that participant. 1.3: An adequate concealment method is used. Answer: No. The authors did not state any methods for concealment when assigning participants into groups. There was no mention whether the researchers knew the sequence of the cards which were used for assigning participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. This study was a single blinded study in which the participants were ‘blinded’ and did not notice whether they were assigned into intervention or comparison groups. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had stated some of the baseline characteristics among the 3 groups, which were the mean ages (P>0.05), mean BMI

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(P>0.05), baseline body temperatures (P>0.05) and the fatigue scores before the study (P>0.05). All of these data were statistically insignificant. However, more data among the participants should be reported such as the genders of participants in each group, nationality etc. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants in each group received the same treatments according to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The results of the study based on the primary outcomes, which were the pain level immediately and 15 minutes after CTR. The reliability and validity of the VAS for pain level measurement was confirmed by Gift (1989) & Lee (1991). 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there was no participants dropped out before the study completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in each group completed all the treatments being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the ICU in Imanm Reza Hospital of Mashhad but not others.

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2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: This study was rated acceptable (+). It was a randomized, single blinded study in which the study participants did not notice which groups they were in. However, a clear concealment method should be stated related to the assignment of participants into different groups. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was certain that the study results were due to the cold application applied in the intervention group, but improvements should be considered. The pain levels of the participants in the intervention group immediately and 15 minutes after CTR were significantly lower than those of the placebo and the control groups. In view of the methodology of the study, a randomization method was listed out clearly, single blinded method was used so that the participants did not aware which group they were in and there were no significant differences in demographic data among the three groups before the study. However, the details for concealment method in assigning participants to the three groups were not stated clearly. There was no mention on how to prevent the researchers from knowing the sequence or codes of the cards when drawing them. In addition, more demographic data such as genders of the participants in each group, nationality etc. should be reported to minimize bias. When viewing the statistical power of the sample, no power analysis being mentioned. In this study, 34 chest tubes were allocated in each group, which were larger in sample size when compared with Demir (2010) study, in which the power of the sample in Demir (2010) study was 81%. Therefore, the samples size in this study was adequate to reflect the effect of cold application on pain level during CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The results of this study showed that the cold application group had significantly reduced the pain level immediately and 15 minutes after CTR when compared with the placebo and the control groups. The application of ice pack around the skin of the chest tubes sites

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was easy, cheap and safe to the patients. It was worth for the health care professionals to consider applying the cold application method to the targeted patients. 2.4: Conclusion and comment for this article: According to the authors, applying ice packs around the skin of the chest tubes sites were easy, cheap and safe method to reduce pain level of the patients during CTR. This study supported the result of Demir (2010) study but contradicted with Sauls (2002) study. The difference of results for this study when compared with Sauls (2002) might due to the longer cold application time being used. This study was a cross-over design, in which each participant act as both intervention and comparison groups at the same time. The advantage for this design is that since the intervention group and the comparison group are conducted in the same person, the baseline difference can be eliminated. However, the disadvantage for this design is the ‘carry over’ effect. The result of the latter group may be due to the carry over effect of the previous group. Although there was a ‘washing period’, in which the time between the CTR of the two chest tubes was 30 minutes, it was difficult to determine whether 30 minutes was enough to eliminate the effect of the previous treatment on the participant. Therefore, if similar cross-over design study will be conducted in the future, the length of the washing period should be investigated so that the effect of the previous treatment can be eliminated before conducting the latter treatment. Otaibi, 2013 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. According to the study, the participants were those cardiothoracic surgery patients with 1 or 2 mediastinal or pleural chest tubes inserted, mean ages were 40.7 years old. All the participants would receive 1 gram perfalgan 60 minutes before CTR. In the intervention group, a

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soft ice pack gel would be placed on top of a sterile gauze pad surrounding the skin of the chest tube until the skin temperature reached 13°C. For the comparison group, placebo pack at room temperature was applied. The primary outcomes were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The secondary outcome were the correlation between pre-CTR anxiety and pain level 15 minutes after CTR and also the correlation between the demographic characteristics of the participants and the pain level before, during and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. It was because the authors only stated that this study was a randomized study, but did not mention any randomization methods. 1.3: An adequate concealment method is used. Answer: No. As there was no mention about any concealment methods used to prevent researches from knowing the assigning sequence of participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, it was a single blinded study in which the participants were not known which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had listed the demographic and baseline characteristics of the participants before the study, such as the gender of each group (P>0.05), the mean ages of each group (P>0.05), the insertion duration of the chest tubes of each group (P>0.05) and also the pain intensity of each group before CTR (P<0.05). Only the pain intensity before CTR of the two groups showed a significant difference but not other characteristics.

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1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received the same treatments corresponding to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Can’t say. The conclusion of the study was based on the primary outcomes, which were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The tool used for rating pain level was VAS and the tool used for rating anxiety level was Hamilton Anxiety Scale. No mention about the reliability and validity of the tools being mentioned in the article. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there were no participants from each group dropped out before the study was completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants completed all the treatments corresponding to the group being assigned. 1.10: where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. The study was conducted in the cardiothoracic surgical ward and also the intensive care unit of King Fahd Hospital. However, no specific data was provided for each site.

2: Overall assessment of the study: 2.1: How well was the study done to minimize bias?

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Answer: The quality of this study was rated acceptable (+). Single blinding method was used to the participants which could reduce bias to the treatments being applied. However, a clear randomization and concealment methods in assigning participants to different groups should be stated clearly. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results were due to the cold application being applied to the participants in the intervention group, but improvements should be considered. The results showed that the pain level was significantly reduced immediately and 15 minutes after CTR in the intervention group when compared with the placebo group. In addition, the anxiety level of the participants in intervention group was significantly lower than those in control group after CTR. In view of the methodology, randomization was mentioned by the authors in assigning patients into two groups. The demographic and baseline characteristics of the participants were similar between the two groups and all the participants received the treatments corresponding to the groups being assigned which could help reduce bias to the study. However, a clear randomization and concealment method should be clearly stated in assigning participants into different groups. Furthermore, the reliability and the validity of the tools used for rating pain and anxiety level, the VAS and the Hamilton Anxiety Scale respectively, should be assessed before using for measurements. Finally, the pain level before CTR for intervention group was significantly higher than those of the control group. The baseline characteristic of the participants should be similar to reduce bias. In view of the statistical power of the sample, there was no mention about the power of the sample size. However, in view of the previous similar studies, 40 participants were not enough to generalize the results to other similar patients. More participants should be recruited in the future studies.

2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results of this study could be directly applied to the target patients. In this study, the pain level was significantly reduced immediately and 15 minutes after CTR in intervention group when compared with placebo group. In addition, the anxiety level was also

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significantly lower in the intervention group than those in the control group after CTR. Therefore, it was worth for the health care professionals to consider applying the cold application method to the targeted patients. Moreover, the soft icepack gel was cheap and safe for applying to patients. 2.4: Conclusion and comment for this article: According to the authors, cold application was effective in reducing pain level immediately and 15 minutes after CTR. It could also reduce the anxiety level of the patients after CTR. In view of the secondary outcomes, the pre-anxiety level of the participants in both groups significantly correlated with the pain level after CTR, which supported the previous thought that the anxiety level might affect the perception of pain. The demographic characteristics of the participants significantly affected the pain level perceived before CTR, but not pain level during and 15 minutes after CTR as shown in this study. This is an interesting point as the targeted patients may have different demographic characteristics such as different ethnicity or religious belief. Some patients may particularly fear to pain while some are not. However, due to the small sample size for this study, the results cannot be effectively generalized to others. Future studies with a greater sample size should be conducted to investigate these effects on pain level being perceived by the patients. Gorji, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question.

Answer: Yes. The study clearly stated the participants, intervention, comparison group and outcomes. The characteristics of participants were those with mean ages 58.1 years old, did not have the experience of CTR before and had 2 chest drains. The study contained 3 groups, which were the cold application, relaxation and control groups. Due to the translational research topic interest, only the results of cold application and

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control groups were considered here. Participants in all groups received oral acetaminophen every 6 hours. In intervnetion group, 3 cold gel packs twisted by gauze of 0°C was placed on the skin surrounding the chest tubes until the skin temperature reached 13°C (average time=10 minutes) as measured by infrared temperature before CTR. For control group, there was no gel pack being applied to the participants. The outcomes were the comparison of VAS scores among the groups immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The author stated that the participants were assigned randomly to the intervention and control groups by using the Excel programme in the computer to generate random number to the participants. For the participants in the intervention group, each of the 2 chest tubes for each participant would have individual assignment. The participants would be divided into 7 bulks with 6 participants in each bulk. 3 cards with codes indicated left pleural cold-mediastinal relaxation treatments while 3 cards with codes indicated left pleural relaxation-mediastinal cold therapy would be randomly selected for the chest tubes. As a result, each of the 2 chest tubes for the patients in the intervention group would receive cold application or relaxation treatment according to the card being drawn. 1.3: An adequate concealment method is used. Answer: Can’t say. The author stated that the assignment of the participants into groups by Excel software in the computer, but did not mention whether the researchers knew the sequence and codes on the cards which were used for allocating chest tubes into different treatments in the intervention group.

1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had stated that this was a single and observer-blinded study. A nurse was trained to record VAS and was responsible for recording the pain level for different groups. The nurse was ‘blinded’ for different treatments applied before CTR.

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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author had presented the baseline characteristics of the participants before conducting the study. The characteristics were the age (P>0.05), the body mass index (P>0.05), the chest tubes remaining time after operation (P>0.05), the sex (same number of males and females for both experimental and control groups), the education level (P>0.05), the occupation (P>0.05) and their living geographical positions (P>0.05). All of these characteristics were not significant in difference between the intervention and control groups. In addition, there were no significant difference in pain level between the cold application and control groups before CTR (P>0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received acetaminophen tablets every 6 hours and received the treatments according to the groups being assigned. Also, the chest tubes in different groups were removed by the same nurse and the VAS score in different intervals were also recorded by the same nurse for all groups. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes in this study were the pain level for the participants immediately and 15 minutes after CTR and the conclusion of this study based on the primary outcomes. The pain level of the participants was measured by using VAS. Both the reliability and validity of this tool for rating the pain level of CABG patients were supported by van Valen et al. (2012).

1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before study was completed. Answer: Not applicable as there was no drop out of participants during the study.

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1.9: All subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Does not apply as all the participants had received all the treatments according to the group being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply as the study was done in Mazandaran Heart Centre only but not multiple sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of this study was acceptable (+). Most of the criteria listed in the checklist were followed, with a good randomization method and as a single blinded study. However, the concealment methods for assigning patients into different intervention groups were not clearly mentioned. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results were related to the cold application applied to the surrounding skin of the chest tubes, but improvements should be considered. The pain levels of the cold application group were significantly lesser than the control group immediately and 15 minutes after CTR. In view of the methodology, it was an observer- blinded, randomized controlled study with a good randomization

method by using Excel programme for assigning participants into interventions and control groups. However, the concealment method was not clearly stated, which might create bias to the results. In addition, for the intervention group, each participant needed to undergo two different treatments for the two chest tubes (Relaxation VS Cold application). The pain level result of the relaxation group might not directly related to the

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relaxation treatment since the cold application was applied to one of the chest tube first before proceeding relaxation treatment to another chest tube (carry over effect). Luckily, the cold application group was the main interest in this translational research but not the relaxation group. The baseline characteristics between the intervention and the control groups were similar, which could reduce the bias towards the results. In view of the statistical power, the power for sample size was 0.99. The sample size for this study was adequate to demonstrate the effect of cold application to pain level of the participants after CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The result of this study can be directly applicable to the target patients undergoing CTR. In this study, the cold application had shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the control group. The cold packs used for the cold application group were cheap and not causing harm to patients. Due to these factors, cold application method was worth for the health care professionals to consider by applying to the target patients to relieve their pain. 2.4: Conclusion and comment for this article: The Author stated that the cold application was worth to be considered during CTR in view of the significant reduction in pain level in the intervention group when compared with the control group. The cold packs used in this study could be easily bent and cover the skin surrounding the chest tube, which could provide a better cooling effect to the skin. This may be the reason to explain why the study results different from that of the results in Sauls (2002). However, this study only focused on pleural and mediastinal chest tubes but not other chest tubes. To increase the generalizability of the study results, CTR to different sites of the chest with a bigger sample size should be studied in the future. Moreover, as the relaxation treatment group also shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the

control group, future studies can consider to investigate the combine effect of relaxation and cold application on pain level during and after CTR.

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Mitra, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. This study clearly stated the target participants: postoperative CABG or CABG with vavular surgery patients with mean ages of 58.7 years old with mediastinal and pleural chest tubes. The study divided into intervention and placebo groups. Participants in both groups will receive 100mg Indomethacin suppository one hour before CTR. In intervention group, a cold gel pack of temperature 4 °C was applied on the skin surrounding the chest tube site for 20 minutes before CTR. In Placebo group, a gel pack of room temperature was applied around the skin of the chest tube site for 20 minutes before CTR. The primary outcomes were pain level in terms of VAS immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that the participants were randomly assigned to the intervention and placebo groups, but no clear randomized method being mentioned. 1.3: An adequate concealment method is used. Answer: No. There was no mention about whether the researchers knew the allocation sequence or not. No concealment methods being reported. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had mentioned that this is a single-blinded study in which the participants did not know whether they were in intervention or placebo group throughout the study.

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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The baseline characteristics between the intervention and control groups were listed in a table such as genders (P>0.05), Ages (P>0.05), length of the chest tubes (P>0.05), weight (P>0.05), BMI (P<0.05), type of surgery (P>0.05), type of analgesic used (P>0.05), Graft number (P>0.05), chest tube diameter (P>0.05), vital sign (P>0.05). Among these data, only the BMI showed a statistical difference between the two groups (P<0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All participants received 100mg indomethacin suppository 1 hour before the CTR. The chest tube was removed by the same health care professional for all the participants. The only difference was that the intervention group received the 4 °C cold gel pack for 20 minutes before CTR while those in the placebo group received the gel pack for 20 minutes at room temperature before CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this study was based on its primary outcomes, which were the pain levels of the participants in different groups immediately and 15 minutes after CTR. The outcomes were measured by using VAS. Reliability and content validity were confirmed by the Zanjan University of Medical Sciences health related committee. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed. Answer: The author had mentioned that there were 2 participants dropped out in the intervention group. The drop out percentage was 5.88% in the intervention group (Total drop out percentage: 3.03%). These 2 patients withdrew because they had respiratory problems during the study.

1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as an intention to treat analysis).

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Answer: No. There was no mention about using intention to treat analysis in analyzing the 2 dropped out participants in the intervention group. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. As the participants were recruited and conducted in the ICU of Alinasab hospital but not other sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+). It was a single blinded study by blinding the participants so that they were not alert whether they were in the intervention or control group. However, the randomization method and concealment method were not clearly stated in this study. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results of the study were due to the application of cold in the intervention group, but improvement of the study needed to be considered. The pain level of the intervention group was significantly lower than those of the placebo group immediately and 15 minutes after CTR. In view of the methodology of the study, randomization was mentioned in assigning participants into different groups. The baseline characteristics for the participants in two groups were similar except BMI. Single blinding method was used to blind the participants so that they were not aware which group they were in. The cold application time was 20 minutes in the intervention group, which provided enough time to cool down the skin to exert the analgesic effect. The only differences between the two groups were only the cold pack and the placebo pack in the intervention and control groups respectively. These measures help reduce biases to the study. However, a clear randomization and concealment methods should be mentioned clearly in assigning participants into different groups. In addition, an intention-to-treat analysis should be done to investigate the effects to the 2 dropped out participants. In view of the statistical power of the study, power of the samples was not mentioned. However, in view of only 68 participants in total, it was not adequate. To demonstrate a medium effect

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size (p<0.05) and a power of 0.8, 128 participants in total should be needed. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results could be directly applicable to the target patient group. It was because this study had produced a significant reduction in pain level immediately and 15 minutes after CTR when cold pack was applied before CTR. Cold application was a safe, cheap and easy to be learnt by the health care professionals. It was worth for them to consider applying the cold application method to the patients before CTR to reduce patients’ pain. 2.4: Conclusion and comment for this article: According to the authors in this study, cold application method was worth to be used to the patients before CTR to relieve pain during this procedure. However, the samples for this study were small which might not be enough to demonstrate the true effects of cold application. Also, cultural differences and anxiety level of the participants were not studied in this study, which might affect the perception of pain by the participants. Therefore, future study should include these factors to conclude their effects on pain perception by the participants.

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Appendix 4

Comparisons between patients in local and literatures settings:

Patient characteristics Local setting Literature settings

Age ranges (years old) 20-70 18-85

Main type of CTS

performed

Lobectomy and

pneumoectomy

Lobectomy and CABG

Location of chest tubes Pleural Pleural, mediastinal and

pericardial

Setting in performing

CTR

Postoperative surgical

ward

Postoperative surgical

ward and clinic, ICU and

CCU

Preparations before

CTR

Prescribe analgesics just

before CTR

Prescribe analgesics 1

hour before CTR together

with cold application or

cold application alone

Nationality China United States, Iran,

Turkey and Saudi Arabia

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Appendix 5

Pain chart and VAS

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Visual Analogue Scale (VAS):

Using a vertical line, please mark your current level of pain on the 10 cm line

below. The pain level of the patient is determined by measuring the length from

no pain (0 cm) to the point in which the patient has marked.

No pain Extreme pain

Sources:

Pain chart: New Territories West Cluster (2008). Acute pain assessment chart. Hong

Kong: Hospital Authority.

VAS: Kahl, C., & Cleland J.A. (2005). Visual analogue scale, numeric pain rating

scale and the McGilll pain questionnaire: An overview of psychometric properties.

Physical Therapy Reviews, 10, 123-128.

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Appendix 6

Costs for implementing cold application versus usual practice in local setting per year (assume 240

patients undergoing CTR per year)

Preparation items Set-up costs for new programme

(in HK dollars)

Operational costs for new

programme (in HK dollars)

Costs for usual practice (in HK

dollars)

Trainer costs 900(i) 0 0

Silica gel cold packs 0(ii) 120 0

Refrigerator with digital

thermometer

0(ii) 0 0

Dressing pads 0(ii) 408(iii) 0

Mefix 0(ii) 1200(iii) 0

Hourmeters 0(ii) 100(iii) 100

Poster for guideline 130 0 0

New pain assessment form (iv) 12.5 137.5 0

Additional Nursing manpower 4800(v) 48000(vi) 0

Analgesics used 310(vii) 3414 5760(viii)

Antibiotics used (ix) 2400 26400 40320

Hospitalization costs (x) 4860000 6804000

Total 4948332 (T1) 6850180 (T2)

Benefits = T2-T1 6850180-4948332 = 1901848

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Footnotes:

(i): Assumed the senior physiotherapist invited has 10 years working experience and

with hourly rate = $300.

(ii): These items are already present before implementation of the new programme.

(iii): Assumed 2 additional dressing pads per patient, 1 additional box of mefix per

month and 2 additional hourmeters are needed per year for patients undergoing

CTR.

(iv): Assumed the minimum number of new pain assessment forms = 25 pages per

month and photocopying cost to be $0.5 per page.

(v): Assumed the nurses recruited have average 5 years working experience and with

hourly rate = $200.

(vi): Assumed 1 nurse is needed to spend 1 hour in preparing 1 patient undergoing

CTR.

(vii): Assumed 1 patient will take 2 tablets of panadol every 6 hours for duration of 1

day, each tablet costs around $1.9.

(viii): Assumed 1 patient will take 2 MST continus per day for duration of 1 day,

each tablet costs around $12.

(ix): Assumed average length of stay of each patient receiving new programme is 5

days while those receiving the usual practice is 7 days. IV Augmentin is used as an

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antibiotic after CTS and being injected 3 doses per day, each ampoule costs $8.

(x): Assumed average length of stay of each patient receiving new programme is 5

days while those receiving the usual practice is 7 days. According to Hospital

Authority press releases about service costs of hospitals (2012), the costs for an

in-patient bed is $4050 per day for 1 patient.

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Appendix 7: Level of the statements and grades of recommendations (SIGN, 2012) Level of evidence

Level of evidence Evidence statements 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low

risk of bias. 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias. 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias.

2++ High quality systematic reviews of case control or cohort or studies. High quality case control or cohort studies with a very low risk of confounding or bias and a

high probability that the relationship is causal. 2+ Well-conducted case control or cohort studies with a low risk of confounding or

bias and a moderate probability that the relationship is causal. 2- Case control or cohort studies with a high risk of confounding or bias and a

significant risk that the relationship is not causal. 3 Non-analytic studies, e.g. case reports, case series. 4 Expert opinion Grades of recommendations

Grade Statements A At least one meta-analysis, systematic review, or RCT

rated as 1++, and directly applicable to the target population; or a body of evidence consisting

principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall

consistency of results. B A body of evidence including studies rated as 2++,

directly applicable to the target population, and demonstrating overall consistency of results; or

extrapolated evidence from studies rated as 1++ or 1+. C A body of evidence including studies rated as 2+,

directly applicable to the target population and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 2++.

D Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+.

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Appendix 8: Evidence based guideline and recommendations

Guideline title:

Cold application programme in reducing procedural pain due to CTR

Objectives:

The aim of this guideline is to relieve the procedural pain suffered by the CTS

patients during CTR. The guideline can help:

1: pick up appropriate CTS patients who are going to undergo CTR,

2: standardize the pain relief preparations before CTR,

3: serve as a revision material for those new comers who are not familiar CTR pain

control.

Target populations:

This guideline is intended to all the nurses who are going to provide pain relief

preparations for the CTS patients before CTR procedure in a local postoperative

surgical unit. The inclusion and exclusion criteria of the patients are shown below.

Inclusion criteria:

1: Patients with ages 20 or above.

2: Patients oriented to time, place and person.

3: CTS patients with at least one chest tube or above undergoing CTR.

4: Able to understand and rate pain level by using VAS.

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Exclusion criteria:

1: Patients who are having psychiatric diseases or dementia.

2: Patients who are having poor visual acuity or blinded.

3: Patients who are oversensitive to cold and allergic to panadol.

Recommendations grading:

(1): VAS is an appropriate tool for assessing patient’s pain level during CTR. (Grade

of recommendation: B)

Evidence: VAS provides a continuum for patients to rate their pain level and easily

being understood by them. It also showed high reliability and validity in assessing

patient’s pain level. [Bijur, Latimer & Gallagher, 2003(2+); Tamiya et al., 2002(2++);

Williams, Davies & Chadury, 2000(4)]

(2): Cold application together with less potent analgesics can effectively reduce CTR

procedural pain suffered by the patients. (Grade of recommendation: A)

Evidence: Cold application has been shown to be effective in providing local

anesthesia around the application area, limiting the inflammatory process, reducing

the request for opioid analgesics and reducing the transmission of the pain impulses

to the brain, which was supported by Gate Control Theory (Melzack & Wall’s, 1965).

The studies of Gorji et al. (2014) and Mitra et al. (2014) with cold application plus

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less potent analgesics administered had been shown significantly reduced in pain

level by -2.2 and 1.23 respectively (p<0.05) when compared with the control group

immediately after CTR. [Barber, McGuire & Click, 1998(1+); Bleakley,

McDonough & MacAuley, 2006(1+); Koc, Yoldas, Dizen & Gocmen, 2006(1+);

Modabber et al., 2013(1+); Sarifakioglu & Sarifakioglu, 2004(1+)]

(3): Silica gel cold packs are more effective in providing cooling effect than ice

packs. (Grade of recommendation: A)

Evidence: Silica gel cold packs are more flexible and easier to be bent than ice

packs in order to provide effective cooling around the chest tube. Similar study by

comparing the cooling effect of cold gel packs and ice packs had been conducted in

applying to postoperative episiotomy wound. Patients with cold gel pads being

applied had significant lower pain level when compared those with ice packs being

applied (p=0.003). [Gorji et al., 2014(3); Zahra et al., 2008(1+)]

(4): The duration for cold application and temperature should be 20 minutes and

around 0-5°C in order to provide adequate analgesic effects to the patients. (Grade

of recommendation: A)

Evidence: Adequate cold application time and low temperature of the cold gel packs

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are important to provide effective cooling to patient’s skin and thus the analgesic

effects. In Sauls (2002) study, the cold application time was 10 minutes, which

showed a non-significant result in pain reduction in the intervention group. Studies

later had prolonged the cold application time to 20 minutes or used patient’s skin

temperature as an indicator for cold application time. Significant results were

yielded after this amendment. [Demir & Khorshid, 2010(1+); Ertug & Ulker,

2011(1+); Gorji et al., 2014(1+); Mazloum et al., 2012(1+); Mitra et al., 2014(1+);

Otaibi et al., 2013(1+); Sauls, 2002(1+)]

(5): The analgesic effects of cold application can be evaluated by VAS and mean

length of time before request for analgesics after CTR. (Grade of recommendation:

A)

Evidence: VAS had been shown to have high stability and reliability to assess

patient’s level as mentioned in statement 1. In Demir & Khorshid (2010) study, the

mean length of time in hours for patients in the cold application intervention group

was 0.3 and 0.43 hours longer than placebo and control groups respectively in

requesting analgesics after CTR (p<0.05), which can act as another indicator to

evaluate the analgesic effects of cold application. [Demir and Khorshid, 2010(1+)]

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Appendix 9: Cold application programme for CTS patients before CTR checklist

Patients are not applicable for this programme if they are: Unit/Dept: 1: having psychiatric diseases or dementia. Date: 2: are having poor visual acuity or blinded. 3: are oversensitive to cold and allergic to panadol.

Procedures Yes No Remarks

1 Administer 1 gram p.o. Panadol according to MAR chart after receiving doctor’s call (1 hour before CTR) and every 6 hours for

one day.

2 Apply silica cold gel packs of +4°C wrapped by dressing pads surrounding the chest tubes and anchored by mefix for 20 minutes

(counted by hourmeter) before CTR at bedside.

3 Transport patient to treatment room and position well for CTR. 4 Record patient’s pain level before CTR by using VAS in pain chart. 5 Remove the cold packs and assist doctor to perform CTR. 6 Perform pressure dressing to old drain site and record patient’s pain

level by using VAS in pain chart immediately after CTR.

7 Record patient’s pain level by using VAS in pain chart 15 minutes after CTR.

8 Record the time and pain level in pain chart each time patient requests for analgesics after CTR.

Remarks: 1: Please put a tick to ‘Yes’ column after completing a procedure before moving on to another procedure. 2: Please put a tick to ‘No’ column if the procedure is not done. Withdraw the programme and record the reasons of fail to complete the procedure in ‘Remarks’ column. 3: Please inform the corresponding CTS doctors if patient withdraw the programme due to serious responses. Doctors may need to assess the patient again to determine whether continue the CTR procedure or suspend it. Nurse for implementing the programme: Name: Signage:

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Appendix 10: Time table for implementation

Workflow Time (Month)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Preparations for presenting programme information to nursing

colleagues in ward meeting

Seek approval from DOM and COS

Forming working group for programme planning and refinement

Prepare posters and send email for promotion

4 RN receive cold application training by senior physiotherapist

before pilot study

Conduct pilot study

Evaluate and amend the protocol based on pilot study results

Training sessions provided by senior physiotherapist and working

group members to all RN

Full implementation of cold application programme

Evaluate patient’s data

Receive feedbacks from involved staffs and evaluate resources

arrangement

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Appendix 11: Integrated Progress Note (For intervention group)

CTS cold application programme progress notes

Patient’s code number: Date & type of surgery: Date of CTR: Drug allergy:

Before CTR Immediately after CTR 15 minutes after CTR Pain score (in VAS)

Number of times for requesting

analgesics Time for additional

analgesics required after CTR

Pain score (in VAS) when requesting for additional

analgesics 1st time 2nd time 3rd time 4th time 5th time

Incidents noticed during the programme (if any): Patient’s comments about the programme:

Please stick patient’s gum label here

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Appendix 12: Integrated Progress Note (For control group)

CTR progress notes

Patient’s code number: Date & type of surgery: Date of CTR: Drug allergy:

Before CTR Immediately after CTR 15 minutes after CTR Pain score (in VAS)

Number of times for requesting

analgesics Time for additional

analgesics required after CTR

Pain score (in VAS) when requesting for additional

analgesics 1st time 2nd time 3rd time 4th time 5th time

Incidents noticed during the procedure (if any): Patient’s comments about the procedure:

Please stick patient’s gum label here