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Abstract of thesis entitled “Implementation of video distraction to alleviate pain of children during venipuncture” Submitted by Ku Sin Yin for the degree of Master of Nursing at The University of Hong Kong in August 2014 Venipuncture of peripheral veins is a painful procedure commonly encountered by pediatric patients during hospitalization. It causes physical consequences and emotional distress of children, it also contributes to negative impact on future pain responses, and therefore increases the difficulty of future care and the cost of care (Bagnasco, Pezzi, Rosa, Fornoni & Sasso, 2012; Inal & Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy & Kleiber 2006; McCarthy et al., 2010; Srouji, Ratnapalan & Schneeweiss, 2010; Uman, Chambers, McGrath & Kisely, 2008; von Baeyer et al., 2004; Yoo et al., 2008). For the alleviation of pain of children during venipuncture, the implementation of video distraction by using TV cartoon and animation movie was reviewed as an effective distraction strategy in studies (Murphy, 2009; Uman et al., 2006). It diverts children’s attention from a stressful situation and redirects their attention towards a pleasant stimulus (McCarthy et al., 2010; Murphy, 2009; Uman et al., 2008). According to the current practice of venipuncture in the targeted local paediatric unit,

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Abstract of thesis entitled

“Implementation of video distraction to alleviate pain

of children during venipuncture”

Submitted by

Ku Sin Yin

for the degree of Master of Nursing

at The University of Hong Kong

in August 2014

Venipuncture of peripheral veins is a painful procedure commonly encountered by

pediatric patients during hospitalization. It causes physical consequences and

emotional distress of children, it also contributes to negative impact on future pain

responses, and therefore increases the difficulty of future care and the cost of care

(Bagnasco, Pezzi, Rosa, Fornoni & Sasso, 2012; Inal & Kelleci, 2012; Kennedy,

Luhmann & Zempsky, 2008; McCarthy & Kleiber 2006; McCarthy et al., 2010;

Srouji, Ratnapalan & Schneeweiss, 2010; Uman, Chambers, McGrath & Kisely, 2008;

von Baeyer et al., 2004; Yoo et al., 2008).

For the alleviation of pain of children during venipuncture, the implementation of

video distraction by using TV cartoon and animation movie was reviewed as an

effective distraction strategy in studies (Murphy, 2009; Uman et al., 2006). It diverts

children’s attention from a stressful situation and redirects their attention towards a

pleasant stimulus (McCarthy et al., 2010; Murphy, 2009; Uman et al., 2008).

According to the current practice of venipuncture in the targeted local paediatric unit,

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there is neither evidence based guideline on interventions for pain management nor

guideline on practicing video distraction. Therefore, this paper aims at reviewing

evidence on the implementation of video distraction to alleviate pain of children

during venipuncture. In addition, a clinical guideline, an implementation plan and an

evaluation plan on implementing video distraction will also be revealed in this paper.

In this paper, critical appraisal on five selected studies, including four randomized

controlled trials and one quasi-experimental study were conducted with the

methodology checklist from Scottish Intercollegiate Guidelines Network (SIGN,

2013), and the four RCTs were of good quality. From the studies, video distraction

was reported as an effective intervention for relieving self reported pain, observational

pain, physiological pain responses of children and emotional distress during

venipuncture, and it also contributes to a higher success rate of venipuncture (Bellieni

et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo

et al., 2011).

In order to translate this effective intervention to the targeted clinical setting, an

implementation plan, which comprises a communication plan, a pilot study and an

evaluation plan, is established. With the implementation of video distraction during

venipuncture, reduction of pain of children and times of venipuncture was expected.

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Implementation of video distraction to alleviate pain

of children during venipuncture

By

Ku Sin Yin

B.Nurs, RN

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at the University of Hong Kong.

August 2014

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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.

________________________________

Ku Sin Yin

August 2014

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Acknowledgement

I would like to express my sincere appreciation to my supervisor, Dr Chow Mei Kuen,

for her kind guidance and support on my dissertation. She has provided me a lot of

advices all along my dissertation. Without her support and inspirations, I could not be

able to finish my dissertation.

I would also like to express my gratitude to teaching staff of School of Nursing, The

University of Hong Kong, for their professional teaching and kind guidance in the

master course.

Thank you so much.

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Content

Declaration……………………………………………………………………………..i

Acknowledgement…………………………………………………………………….ii

Table of content………………………………………………………………………iii

Chapter 1: Introduction

1.1 Background………………………………………………………………………..1

1.2 Affirming the need………………………………………………………………...2

1.3 Objectives and significance………………………………………………………..5

Chapter 2: Critical appraisal

2.1 Search and appraisal strategies

2.1.1 Identification of studies……………………………………………………….... 7

2.1.2 Data extraction…………………………………………………………………..7

2.1.3 Appraisal strategy………………………………………………………………..8

2.2 Results

2.2.1 Search result……………………………………………………………………..9

2.2.2 Study characteristics……………………………………………………………10

2.2.3 Methodological issues………………………………………………………….12

2.3 Summary and synthesis

2.3.1 Summary of data……………………………………………………………….16

2.3.2 Synthesis of data………………………………………….…...……...……….. 20

Chapter 3: Translation and Application

3.1 Target setting……………………………………………………………………..23

3.2 Transferability of the findings……………………………………………………23

3.3 Feasibility………………………………………………………………………...26

3.4 Potential risks and benefits of the innovation……………………………………29

3.5 Evidence-based guideline.......................................................................................31

Chapter 4: Implementation Plan…………………………………………………..36

4.1 Identifying the stakeholders……………………………………………………...36

4.2 Communication Plan……………………………………………………………..37

4.3 Communication process and implementation strategies…………………………37

4.4 Pilot testing plan………………………………………………………………….38

4.5 Design of the pilot test…………………………………………………………...39

4.6 Subject recruitment………………………………………………………………39

4.7 Data collection……………………………………………………………………39

4.8 Review of guideline……………………………………………………………...40

4.9 Sustaining the change……………………………………………………………40

Chapter 5: Evaluation plan

5.1 Identifying outcomes…………………………………………………………….41

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5.2 Timing and frequency of data measurement……………………………………..43

5.3 Nature and number of clients to be involved ……………………………………43

5.4 Data analysis..……………………………………………………………………44

5.5 Evaluation on the effectiveness of change of practice…...………………………45

Chapter 6: Conclusion…………………………………..………..……...….…….. 46

Appendices

Appendix 1: Search process...………………….…………………………………… 47

Appendix 2: Table of evidence……………………………………………………... 48

Appendix 3: Quality Assessment of Selected Studies………….………..…….…… 52

Appendix 4: SIGN Methodological Quality Coding: Levels of Evidence…………..63

Appendix 5: Grades of Recommendations………………………….…….……..….. 64

Appendix 6: Venipuncture Record…………………………………………….……. 65

Appendix 7: Pain Scale....……………………………………………………………66

Appendix 8: Satisfactory Survey for Healthcare Providers…………………………. 67

References ………………………………………………………………..................68

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Chapter 1 Introduction

1.1 Background:

Venipuncture is an invasive procedure which induces pain by puncturing with a

needle. Venipuncture of peripheral veins is commonly encountered by pediatric

patients during hospitalization, and it is one of the most fearful procedures in the

hospital stay (McMurtry et al., 2011). To alleviate pain of children during

venipuncture, video distraction was implemented and shown to be effective in studies

(Murphy, 2009).

It is important to control pain induced by venipuncture. Evidences show that

procedural pain contributes to psychological and physical consequences, such as

emotional distress and changes in heart rate, increase in blood cortisol level and blood

glucose level (Inal & Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy

et al., 2010; Srouji, Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). It also

negatively affects the future pain responses of children which causes unwillingness of

cooperation and increases the difficulty of future care, and it is even associat with

long-term consequences such as avoidance of health care in adulthood (Bagnasco,

Pezzi, Rosa, Fornoni & Sasso, 2012; McCarthy and Kleiber 2006; von Baeyer et al.,

2004). Since the alleviation of the procedural pain is associated with the ease of the

procedure in terms of time and success rates, the cost of care would also decrease

(Kennedy, Luhmann & Zempsky, 2008; Uman et al., 2008).

For the pain management of venipuncture, there are pharmacological and

non-pharmacological interventions. For pharmacological intervention, topical

application of eutectic mixture of local anesthetics (EMLA) cream is commonly used.

For non-pharmacological interventions, various choices are available for controlling

the pain such as distraction, imagery, hypnosis, breathing exercises, procedural

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education, positive reinforcement, etc., evidences show that distraction is an effective

strategy for pain management. (McCarthy et al., 2010; Murphy, 2009).

Distraction is a cognitive coping strategy which diverts children’s attention from a

stressful situation and redirects their attention towards a pleasant stimulus (McCarthy

et al., 2010; Uman, Chambers, McGrath & Kisely, 2008). It includes a passive

redirection of the child’s attention or an active involvement of the child with a task,

for example, listening to music or story via headphones, playing with toys, looking

through a kaleidoscope, playing games, watching a video, etc. (Kleiber & Harper,

1999; Murphy, 2009). The administration of distraction is safe, easy, and requires less

resources (McCarthy & Kleiber, 2006; Wang, Sun & Chen, 2008).

Murphy (2009) reviewed on distraction techniques for venipuncture and mentioned

that passive distraction by playing video had a positive effect in the alleviation of the

pain of children during venipuncture. For the videos used for distraction in the studies,

TV cartoon and animation movie were included (Murphy, 2009).

1.2 Affirming the need

In one of the pediatric wards of a local hospital, it consists of a general unit and a

pediatric intensive care unit (PICU). In the general unit, there are general pediatric

patients commonly admitted for fever, upper respiratory tract infections, chest

infection and gastroenteritis; there are also several specialties in the ward, including

neurosurgery, neurology and respiratory, patient are commonly admitted for head

injury, convulsion, preparation for investigation such as CT and MRI and

pre-operation preparation.

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Venipuncture on peripheral veins is usually performed for taking blood samples and

obtaining an intravenous (IV) access for administration of antibiotics, intravenous

fluid, anticonvulsants and sedation. According to the Phlebotomist record in the ward,

there are more than 1,000 patients requiring peripheral venipuncture from Jan to

mid-October in 2013 (Phlebotomist Record, 2013). Since venipuncture should be

done by medical officer, house officer and trained phlebotomist in the ward, the actual

number of patients required venipuncture may be underestimated.

Patients requiring venipuncture are usually brought into the treatment room by health

care staff, and no accompany of caregiver is allowed throughout the procedure.

Before venipuncture, explanation would be given to the patients and relatives about

the purpose and process of the venipuncture procedure, the level of cooperation of

patients would be assessed by nurses. If patients are likely to be uncooperative, before

the venipuncture, physical restrains are commonly applied by at least one health care

worker or nurse to restrict the movement of patients until the venipuncture finishes.

Even pain was observed from behavioral response or verbally expressed by the

patients during the procedure, no intervention for relieving the pain would be

provided. After the venipuncture, crying, fear of health care professionals and

uncooperative behavior in subsequent examinations and treatment procedures are

commonly observed.

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Venipuncture is one of the most common sources of pain in pediatric patients, the pain

induces psychological and physical impacts, which effects can be long-term (Inal &

Kelleci, 2012; McCarthy et al., 2010). For physical impacts, it causes the increase of

cortisol levels, and thus heart rate, cardiac output, and blood pressure (Inal & Kelleci,

2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji,

Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). For psychological impacts, it

causes emotional distress (Uman et al., 2013). To alleviate the pain due to

venipuncture is therefore necessary.

Although child response to the invasive procedure may be affected by preparation

given to them prior to the procedure, the provision of information and explanation

was shown to be not effective in the reduction of distress as children may not able to

process and remember information, especially for younger children (Jaaniste, Hayes

& von Baeyer, 2007; McCarthy et al., 2010). Besides, younger children present more

behavioural distress and pain during medical procedure (McCarthy et al., 2010), the

alleviation of pain among them would be even more essential.

Among various non-pharmacological interventions for relieving pain of pediatric

patients during painful procedures, distraction is the most commonly used strategy.

The effectiveness of pain relief is believed to be related to the limited capacity of

brain for focusing on stimulation, attention to the painful stimulus would be reduced if

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the attention is diverted to a distraction (Inal & Kelleci, 2012). For the distraction

method, audio-visual distraction was reported as one of the most effective

non-pharmacological interventions for pain relief, and watching a video of cartoon or

animation is suggested to be effective (Murphy, 2009; Uman et al., 2006).

Reviewing the current practice of venipuncture in the ward, there is no evidence based

guideline on interventions for the alleviation of pain during venipuncture nor

guideline on practicing distraction during venipuncture. Therefore, it may be possible

to apply distraction to make venipuncture a less painful procedure.

1.3 Objectives and Significance

As pain caused by venipuncture contributes to negative psychological and physical

consequences, and also negatively affect future pain responses and future care, to

alleviate pain caused by venipuncture is essential, especially for younger children. As

video distraction may be effective in reducing pain of paediatric patients caused by

peripheral venipuncture, a review on available evidences of video distraction for

alleviation of pain of children aged from 1 to 9, without developmental delay or visual

or auditory deficits during venipuncture was done with the following objectives:

1. To systematically review the current literatures on the effect of video distraction on

the alleviation of pain during venipuncture

2. To develop an evidence-based guideline for applying video distraction during

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venipuncture in the pediatric unit.

3. To develop strategies on the implementation of the evidence based guideline of

video distraction for patients in the pediatric unit.

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Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies

2.1.1 Identification of studies

Studies were searched in three electronic databases, the Pubmed, CINAHL Plus

(EBSCOhost) and British Nursing Index (ProQuest), with the search terms including

‘needle’, ‘ IV access’, ‘IV cannulation’, ‘venipuncture’, ‘venipuncture’, ‘TV’,

‘audiovisual’, ‘Visual audio’, cartoon’ and ‘distraction’. During the searching process,

no restriction on the year of publication was applied. For studies which met the

selection criteria, 5 studies are available on Pubmed, 3 studies are available in

CINAHL Plus, and 2 studies are available in the British Nursing Index. However, the

studies from the three electronic databases were duplicated, therefore, only 5 studies

which met the selection criteria are available. The details of the searching process are

illustrated in Appendix 1.

For the inclusion criteria, randomized controlled trial (RCT) and quasi-experimental

studies done on pediatric patients of age from 1 to 9 were included. For the exclusion

criteria, articles which were not published in English and studies done on children

with developmental delay or visual or auditory deficits were excluded.

2.1.2 Data extraction

The 5 studies which met the selection criteria were selected as they met the inclusion

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criteria and did not meet any of the exclusion criteria. The details of the five studies

are presented in the tables of evidences, in which study design, evidence level, sample

size, subject characteristics, interventions, control, outcome measures, p value and

effect size are included. The tables of evidences are included in Appendix 2.

2.1.3 Appraisal strategy

To evaluate the quality of the selected five studies, critical appraisal of the studies

were conducted with the methodology checklist from Scottish Intercollegiate

Guidelines Network (SIGN, 2013). Studies with are rated as high quality and

indicated with ‘++’ in the table of evidence if a majority of the criteria in the checklist

were met, there was little or even no risk of bias, and further research did not likely

have differences compared to the result of the study. For studies which have most of

the criteria met, but some weaknesses were found to be related to the risk of bias, and

further studies may make differences from the conclusions of the study, they were

rated as acceptable and indicated with ‘+’. Studies were rated as low quality and

indicated with ‘0’, if the studies did not ever meet most of the criteria of the checklist

or had significant weaknesses that was associated with the main features of the study

design, and further studies probably make different conclusions. The critical appraisal

checklists of the five studies are included in Appendix 3.

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2.2 Results

2.2.1 Search result

Searching of evidences was done on 5th October, 2013, using the search terms and

electronic databases mentioned above. A total of 204 studies were available in

Pubmed by using the searching strategy as illustrated in Appendix 4. After screening

of titles and abstracts, and removal of duplication was done, there were only 8

potential studies left, other studies were excluded because the subjects of studies were

adult, the studies were focused on relieving pain during immunization, and the studies

were news. For the potential studies, after reading the full text, 3 studies were

excluded because the distraction method used in the study was not video distraction.

Therefore, only 5 studies met the selection criteria. In CINAHL Plus, using the same

searching strategy, there were only 3 studies available, other studies were excluded

because of the same reasons as mentioned above, in addition, two of the excluded

studies were published in Italian. In British Nursing Index, using the search terms of

‘needle’, ‘IV access’, ‘IV cannulation’, ‘venipuncture’ and ‘venipuncture’, a total of

464 studies was found, after narrowing the result by only including studies done on

children and pain, 28 results were available, after screening the title abstracts and

reading the full text, there were 2 studies left. However, the 3 available studies in

CINAHL Plus and the 2 available studies in British Nursing Index duplicated with the

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5 available studies in Pubmed. Therefore, there were 5 studies available for review as

shown in the tables of evidence.

2.2.2 Study Characteristics

In the 5 selected studies, there were four RCTs and one quasi-experimental study. The

studies were conducted in five different countries, including China, United States,

South Korea, Italy and Netherlands. There was no local study available. All of them

were single-center studies conducted in pediatric department, emergency room and

out-patient department. For the source of funding, the study of Wang et al.(2008)

declared no financial support, and the study of Maclaren & Cohen (2005) was

supported by a Routh Student Research grant, however, the source of financial

support was not mentioned in the other three selected studies (Bellieni et al., 2006;

Tak & van Bon, 2005; Yoo et al., 2011), About the subject characteristics, the age

range of children participating in the five studies were different from each other, the

study of Maclaren & Cohen (2005) and the study of Yoo et al. (2011) were done with

younger children of age under 7, but the age of study populations of the five studies

was within the range of 1 to 12 as presented in the tables of evidence in Appendix 2.

For the interventions, either cartoon or animation was used for distraction in the

intervention groups in the five studies, but they were not the only intervention group

for comparison, in the studies except the study of Yoo et al.(2011). The active

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distraction by mother, interactive toy, provision of information, ELMA cream and

psychological intervention were also arranged in another intervention group for

comparison with the control group in the other four studies (Bellieni et al., 2006;

Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008). For the control

groups, no distraction was provided in all studies. For the outcome measures, apart

from pain rated by children, pain of children rated by caregiver and nurses and child

distress, including pain as one of the components, behavioral pain responses, child

engagement in distraction, cooperation, venipuncture times, and even physical

parameters including blood cortisol level blood glucose level and heart rate were also

included as outcome measures in the five selected studies (Bellieni et al., 2006;

Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011).

As pain scales were used for evaluation of pain responses, mean pain score were

reported in every study, calculation of Cohen’s d was used for the calculation of effect

size. After calculating the effect size of the studies, medium to large effect size was

noted in 4 studies with Cohen’s d from 0.5 to 0.9, and small effect size was noted in

the study of Wang et al.(2008) with Cohen’s d of 0.3. About the significance, the p

value of the four studies ranged from less than 0.01 to 0.047 (Bellieni et al., 2006;

Maclaren & Cohen, 2005; Wang et al., 2008; Yoo et al., 2011). Though the p value

was not reported in the study of Tak & van Bon (2005), the study showed moderate

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effect of video distraction on the alleviation of pain of children during venepuncture.

2.2.3 Methodological issues

After assessing the quality of the selected studies with the checklist of SIGN(2013),

the study of Wang et al., (2008) was rated as good quality and was indicated with ‘++’,

the study of Yoo et al. (2011) was rated as low quality and was indicated with ‘0’, and

the quality of the studies of Bellieni et al. (2006), MacLaren & Cohen (2005), Tak &

van Bon (2005) were rated as acceptable and where indicated with ‘+’. The Wang et al.

(2008) was rated as good quality because it fulfilled the majority of the criteria listed

in the checklist, the other three RCTs were rated as acceptable because some

limitations were found. The methodological issues of the studies are going to be

discussed.

In all of the selected studies, clear research questions were clearly mentioned in each

study. About the random assignment of study participants, except the study of Yoo et

al. (2011) which is a quasi-experimental design, all the other four studies are RCTs. In

the study of Bellieni et al. (2006) and the study of Wang et al. (2008), study

participants were randomly assigned to different groups according to the random

number sequence generated by the computer, and the sequence of number was

specifically generated with Research Randomizer in the study of Wang et al. (2008).

In the study of MacLaren & Cohen (2005), children were randomly assigned to the

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movie distraction group, interactive toy group and control group on alternate bases.

For the concealment method, out of the five studies, the study of Wang et al., (2008)

was the only study that applied concealment with sealed envelopes. However, both

blinding of study participants and investigators about the allocation of treatment were

not possible due to the nature of the studies, which were also reported the studies

(Bellieni et al., 2006; Maclaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,

2008; Yoo et al., 2011).

About the subject characteristics of the treatment groups and the control group, a

comparison was done in each study. In the study of Yoo, et al. (2011), subject

characteristics of the intervention group and the control group were similar except for

the age, 5 more patients in the experimental group were between 5 to 7 years old

while 5 more patients in the control group were between 37 and 48 months old, the

difference of age was significant with the p value of 0.046, and the age of children in

the experimental group was greater than those in the control group by 10.5 months. In

the other four studies, comparing the intervention group and the control group, no

significant difference of the subject characteristics was noted before the trial started. ).

In the study of Bellieni et al. (2006) and the study of Wang et al. (2008), simple

figures and percentage were listed in tables for comparison of subject characteristics

respectively. In the study of MacLaren & Cohen (2005), Chi-square analyses and

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analyses of variance (ANOVAs) were used to investigate for any significant

differences between groups in terms of subject characteristics, while F-values and

Chi-square analyses were applied in the study of Tak & van Bon (2005).

In all of the studies, details of interventions were clearly mentioned, whereas no

additional intervention was applied to the intervention group or the control group

which may cause bias.

For the measurement of outcomes, pain of children during venipuncture was assessed

with Oucher scale in the studies of Bellieni, et al. (2006) and Tak & van Bon (2005).

Oucher scale was a widely used scale for assessment of pain in children, the

application of the scale for children aged 3 years old or above are suitable, and its

validity was supported by evidences. (Beyer, Turner, Jones, Young, Onikul & Bohaty,

2005; Tomlinson, von Baeyer, Stinson & Sung, 2010) As the age of subjects were from

3 to 12 in the study of Tak & van Bon (2005), and children in the study of Bellieni et al.

(2006) were aged between 7 and 12, Oucher scale was valid for both studies. In the

study of Wang et al., (2008), Visual Analog Scale (VAS) was used. Evidences

reviewed VAS as a valid tool for self-reported pain of children from the age of five,

as the subjects in the study of Wang et al. (2008) were aged from 8 to 9, VAS was a

valid scale for the study (Crellin, Sullivan, Babl, O'Sullivan, & Hutchinson, 2007;

Tomlinson, von Baeyer, Stinson & Sung, 2010). In the study of Yoo, et al. (2011),

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5-point Poker Chip Scale was used for self- reported pain of subjects aged 4 or above,

and Faces Rating Scale of Wong and Baker (1988) was used for behavioral pain

responses, both scales were reviewed as preferable and valid (Tomlinson, von Baeyer,

Stinson & Sung, 2010). For the assessment of distress, Observation Scale of

Behavioral Distress (OBSD) was used in the study of MacLaren & Cohen (2005), the

validity of the scale was widely proved (Crellin, Sullivan, Babl, O'Sullivan,

& Hutchinson, 2007).

In all studies, the drop-out rate was 0%, and intention to treat analysis was conducted.

However, in the study of MacLaren & Cohen (2005), missing of data was noted due

to due to equipment or human errors. 12.9% of the patients aged 4 to 7 involved in did

not self-report their post-procedural distress, and 6.8% of patients did not have video

data for coding for Child observational distress, child engagement in distraction, nurse

distraction, or care giver distraction. The data were considered as missing data which

did not have any compensatory actions.

In conclusion, the four RCTs fulfilled most of the criteria included in the checklist of

SIGN(2013), while the study of Yoo, et al. (2011) have more methodological

limitations in terms of randomization, concealment, blinding, small difference in

subject characteristics between intervention group and control group. Therefore, the

study of Yoo et al. (2011) was rated as poor quality, while others were in acceptable to

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good quality.

2.3 Summary and Synthesis

2.3.1 Summary of data

All the five studies fulfil the selection criteria, there were patients within the age

range of 1 to 9 who required venipuncture, and no patient in the selected studies met

any of the exclusion criteria including developmental delay, visual or auditory deficits,

or altered mental status.

In the five studies, the outcome measures were pain rated by children, pain of children

rated by observers, including caregiver and nurses, child distress including pain as one

of the components, behavioral pain responses, children’s engagement in distraction,

cooperation, times of venipuncture, blood cortisol level, blood glucose level and heart

rate (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et

al., 2008; Yoo et al., 2011).

Pain rated by children was included in four studies, including the studies of Bellieni et

al., (2006), Wang et al. (2008), Tak & van Bon (2005) and Yoo et al. (2011). The

effectiveness of video distraction on relieving self-reported pain was supported with

significant results. Significance was shown in the studies of Bellieni et al.(2006),

Wang et al. (2008) and Yoo et al. (2011), with the p value of 0.037, 0.047 and 0.029

respectively. The p value was not mentioned in the study of Tak & van Bon (2005),

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but the study showed a moderate effect (Cohen’s d = 0.5) of video distraction on

reducing self-reported pain. In addition, the strong effect size of video distraction was

shown in the studies of Bellieni et al. (2006) and Yoo et al. (2011), with Cohen’s d

equals to 0.77 and 0.72 respectively. Apart from self-reported pain, pain rated by

caregivers and behavioral pain responses were also under investigation (Bellieni et al.,

2006; Yoo et al., 2011). Video distraction was significant in relieving the pain of

children rated by caregivers in the study of Bellieni et al. (2006), with significant p

value 0.045 and moderate effect size with Cohen’s d equals to 0.6. Furthermore, in the

study of Yoo et al. (2011), statistical significance was shown in reducing the

behavioral pain response observed, the p value was 0.002, and the effect size was up

to 1.02. The study of Maclaren & Cohen (2005) also showed significant results in

reduction of distress reported by children and distress reported by caregiver, with pain

as one of the components of distress, and faces pain scales and VAS were used, the p

values were less than 0.01 and the effect sizes were strong with Cohen’s d equals to

0.7 and 0.9. From the physiological responses, including increase of blood cortisol

level, blood glucose level and heart rate investigated in the study of Yoo et al. (2011),

although there is no significant difference in heart rate between the video distraction

group and the control group, there were significantly lower blood cortisol level and

glucose level in the video distraction group compared to the control group (Yoo et al.,

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2011), hence, the video distraction was also effective in reducing the physiological

response. According to studies, changes in heart rate, increase in blood cortisol level

and blood glucose level have positive associations with pain (Inal & Kelleci, 2012;

Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji, Ratnapalan &

Schneeweiss, 2010; Yoo et al., 2008). Therefore, video distraction is an effective

intervention for relieving self reported pain, observational pain, and also physiological

pain responses of children during venipuncture with evidences support, according to

the selected studies (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,

2005; Wang et al., 2008; Yoo et al., 2011).

Children distress during venipuncture was under investigation in the studies of

MacLaren & Cohen (2005) and Tak & van Bon (2005). The response of distress

mentioned in the two studies included crying, screaming, breathing, increased rigidity

of muscle, flail, verbal fear and resistance to the procedure, looking for emotional

support and verbal pain (MacLaren & Cohen, 2005; Tak & van Bon, 2005). Though

the results of the two studies did not reach statistical significance which may be due to

the small sample size of the study. Both the study of MacLaren & Cohen (2005) and

the study of Tak & van Bon (2005) showed a moderate effect size of video distraction

on reduction of observational distress in children during venipuncture and just before

venipuncture respectively, both with Cohen’s d of 0.5.

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The outcome measure of engagement of child in distraction was only included in the

study of MacLaren & Cohen (2005) out of the five studies. With the p value less than

0.01, the study showed that children in the video distraction group were significantly

more engaged in the distraction comparing to the children in interactive toy group and

the control group (MacLaren & Cohen, 2005). From the correlations conducted in the

study, it showed that more engagement was related to less distress in children during

venipuncture (MacLaren & Cohen, 2005). Therefore, the promotion of engagement of

children in the distraction strategy would reduce the distress of children during

venipuncture.

Cooperation and times of venipuncture were only under investigation in the study of

Wang et al. (2008). In terms of the number of times of venipuncture, higher successful

rate was noted in the video distraction group at the first attempt of venipuncture, in

comparison to the control group (Wang et al., 2008). Video distraction has a

significant effect on the number of attempts required for successful venipuncture

when compared to the control group, with the p value less than 0.05 (Wang et al.,

2008). However, in terms of cooperation, there was no statistical difference between

the video distraction group and the control group (Wang et al., 2008).

In conclusion, video distraction is effective in reducing the pain of children during

venipuncture (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005;

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Wang et al. (2008); Yoo et al., 2011), it also has a positive effect in reduction of

distress which may be due to the engagement of children in distraction (MacLaren &

Cohen, 2005; Tak & van Bon, 2005). In addition, it has a positive effect on the

successful rate of venipuncture (Wang et al., 2008).

2.3.2 Synthesis of data

To apply the video distraction in the pediatric unit, target population should be

identified. With reference to the inclusion criteria and exclusion criteria of the

selected studies, children who are in the age range from 1 to 9 and require

venipuncture would be included, for children who have experienced venipuncture

within 3 months, with self-reported pain or pain as assessed by nurses, diagnosis of

developmental delay, visual or auditory deficits, or altered mental status such as

sedated patients, patients with post-ictal drowsiness and comatosed patients, they

would be excluded (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,

2005; Wang et al., 2008; Yoo et al., 2011). For children who meet the inclusion

criteria and do not have any of the exclusion criteria, the application of video

distraction should not have any contraindication, and none was reported in the studies

(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,

2008; Yoo et al., 2011).

For the choices of video for distraction, the selection should be age appropriate as

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stressed in the studies of Bellieni et al., (2006) and MacLaren & Cohen (2005). In

addition, choices of video should be provided to patient to select according to their

interests, as their preferences on video may be different according to their age and

gender, or simply personal interests, the cartoon may be provided for younger

children and animation movie may be a suitable choice for older children (MacLaren

& Cohen, 2005; Wang et al., 2008). From the studies, cartoon or animation used for

distraction was played in English, to apply in the local pediatric unit, choices of video

of different language including Cantonese, English and Mandarin should be provided.

To have successful distraction, video played should be able to gain their interest in

order to divert their attention from venipuncture.

For the time of initiation of video distraction, it should be started at least 2 minutes

before starting venipuncture according to the studies (Bellieni et al., 2006; MacLaren

& Cohen, 2005; Wang et al., 2008). Moreover, the distraction should be conducted

continuously throughout the whole process of venipuncture until the procedure

finished for continuity of distraction.

About the equipment required, as suggested in the studies, DVD players could be

used for playing videos for distraction (MacLaren & Cohen, 2005; Wang et al., 2008),

which are already available in the pediatric unit.

From the study of MacLaren & Cohen (2005), engagement in distraction is an

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important factor for distress rated by children. To ensure engagement, the

environment may be important. For the location, the venipuncture can still be

performed in the treatment room in order to provide a quiet environment for the

implementation of video distraction. In a quiet environment, environmental stimulus

would be reduced, the engagement and adherence of children to the video distraction

would be promoted.

Presence of caregiver during venipuncture may be helpful, with no active distraction

from the caregiver required, the presence of the caregiver may promote the adherence

of children to the video and therefore increasing the engagement in the video

distraction (Bellieni et al., 2006; MacLaren & Cohen, 2005).

In conclusion, to reduce pain of children during venipuncture, video distraction

should be applied to children of age between 1 and 12. The intervention should be

conducted in the treatment room and started at least 2 minutes before venipuncture,

moreover, various choices of video should be provided and chosen according to

patient’s interest.

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Chapter 3: Translation and Application

The previous chapter demonstrated that the implementation of video distraction

during venipuncture, with the use of cartoon and animation, is effective in alleviation

of self-reported pain, observational pain, physiological response and observational

distress of pediatric patients aged from 1 to 12 (Bellieni et al., 2006; MacLaren &

Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). In addition,

it has a positive effect on the success rate of venipuncture (Wang et al., 2008).

In this chapter, the application of video distraction for alleviation of pain of children

during venipuncture in the target clinical setting would be illustrated.

3.1 Target setting

The intervention could be considered to be implemented in the pediatric unit of a

public hospital in Hong Kong. The target patients would be pediatric patients of age 1

to 9 admitted to the unit, who are in need of venipuncture.

To estimate the implementation potential, the transferability of the findings, feasibility

of the intervention and cost-benefit ratio of the innovation would be assessed.

3.2 Transferability of the findings

For the characteristics of the target population, the intervention would only be applied

to patients without any diagnosis of developmental delay, visual or auditory deficits,

or altered mental status, such as confused, sedated, comatose, etc., as none of the

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selected studies were done on patients with the above characteristics, the

characteristics of the study participants were similar to the target population.

For the issue of age range, the subjects of the selected studies were pediatric patients

with an age range from 1 to 12, while the age range of the target patients in the

pediatric unit would be from 1 to 9. For the gender, there was no significant

difference in gender of participants in the selected studies. The gender distribution of

patients requiring venipuncture in the proposed unit is unknown, since venipuncture

can be done by phlebotomists, houseman, doctors and nurses, venipuncture could be

done without recording in the Phlebotomist record. However, it is unlikely to have a

great difference in gender as the patients in the proposed unit were mostly admitted

for infections. Therefore, in terms of age and gender, the population of selected

studies is similar to those of target setting.

Although three selected studies were conducted in out-patient departments (Bellieni et

al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005), one was conducted in the

emergency room (Yoo et al., 2011), and only one was conducted in the pediatric

department (Wang et al., 2008), as all participants of the selected studies were

children having venipuncture, in terms of patient characteristics and procedure, the

studies were similar to the target setting, the implementation of the intervention in a

pediatric unit should be transferable.

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Besides, the philosophy of care of the innovation is consistent with the philosophy of

care of HA. The implementation of the video distraction with cartoon or animation

during venipuncture is mainly for the alleviation of procedural pain caused by

venipuncture, and therefore its psychological and physical consequences (Inal &

Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010; Srouji,

Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). The Hospital Authority (HA)

requires nurses to be competent in providing holistic caring service, and to provide

people-centered care is the value of HA (HA, 2006; HA, 2013). With a caring heart,

to implement the intervention and reduce the pain and the corresponding

psychological and physical impact is a way to practice the value of HA.

The proposed innovation would benefit a number of patients in the target setting.

According to the Phlebotomist record in the ward, there are more than 1,000 patients,

aged 1 to 9, and undergone peripheral venipuncture from Jan to mid-October in 2013

(Phlebotomist Record, 2013). As the characteristics of patients admitted to the unit in

the following year would be similar in terms of age and diagnosis, the reasons of them

require venipuncture would also be similar, there would be still quite a number of

patients benefiting from the innovation.

To test the transferability, a pilot test would be conducted in the target clinical setting.

The estimated time for implementation and evaluation of the proposed innovation will

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be around one year. First, assessment of the available cartoon and animation DVDs

will be done, and funding will be applied for purchasing DVDs of cartoon or

animation. Although there are already DVD players and some cartoon or animation

DVDs available from the play therapist in the department, as the targeting children are

of age from 1 to 9, the available DVDs of cartoon or animation may not be suitable

for targeting children of different age, a larger variety of choices may be necessary.

When DVDs are available, briefing sessions and the guideline of the proposed

intervention will be provided to all related staff before commencing the intervention.

About one month after the end of all briefing sessions, all related staff should be able

to familiar with the intervention, and data collection will then be started. The data

collection period would be around half year, and then the evaluation would be

conducted. The estimated time of one-year is reasonable for implementing the

intervention and evaluating its efficacy.

3.3 Feasibility

In the proposed setting, nurses are able to implement evidenced based innovation with

the approval of the ward manager (WM) and the department operations manager

(DOM), they are also able to terminate the innovation if it is evaluated to be

ineffective or inapplicable. Therefore, administrative support is important. In the

pediatric department of the proposed unit, nurses are encouraged to take part in

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evidence based studies sharing and launch a new practice with evidence support. In

the past few years, at least one innovation or amendment of practice was commenced

each year. The climate of the proposed unit is supportive of the implementation of the

intervention.

Apart from the administrative support, the support of all related staff, including

Phlebotomist, nurses, doctors and supporting staff is also important. The significance

and effectiveness of the intervention and the workload would be introduced to them in

order to gain their consensus. Therefore, the briefing sessions of evidence-based

guideline is important for convincing the staff. Other than the significance and the

effectiveness of video distraction for alleviation of pain during venipuncture, the

workload for implementing the intervention may be a more important concern to staff.

Extra time may be needed for preparing the video, for example, time for patients to

select cartoon or animation to be watched during the venipuncture procedure, and to

start the video at least two minutes before venipuncture. However, the intervention

would not be time consuming if the staff doing the venipuncture doing preparation for

the procedure while the supporting staff preparing the video for the patient. In fact,

the extra time used should not be long and cause interference to their work. For the

manpower, no extra manpower would be needed. Therefore, there should not be a

great increase of workload in terms of manpower and time consumption, the support

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of staff should be available.

For the equipment, DVD players and DVDs of cartoon and animation are already

available in the unit. In order to implement the intervention, we only need to increase

the variety of cartoon or animation for children of different ages and speaking

different languages. As most of the patients in the unit speak Cantonese or English,

the preparation would not be difficult.

To implement the intervention, staff should be able to identify target population and

practice the distraction according to the guideline. Therefore, the inclusion and

exclusion criteria of the target population, the guideline of the intervention, the

operation of the DVD player will be explained in briefing sessions. In addition, the

evaluation method will also be explained. Briefing sessions will be arranged in

separate days in the ward, 30 minutes before the handover of shifts, so as to facilitate

more related staff to attend the sessions. The duration of a briefing session, which

lasts for 30 minutes, should be reasonable, staff may be willing to join the session

during work or before work.

For the evaluation, Visual Analog Scale used in selected studies, would be used for

assessment of pain (Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon,

2005; Wang et al., 2008; Yoo et al., 2011). Assessment would be done by nursing

staff, as both scales are already currently used scales, no extra training and materials

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would be needed.

In conclusion, with the approval of administrative staff, the support and joint effort of

frontline staff, and the availability of equipment, it is feasible to implement the

innovation in the target clinical setting.

3.4 Potential risks and benefits of the innovation

Concerning the cost-benefit ratio of the implementation of the intervention, the

potential risks, benefits and costs including the material and non-material costs will be

reviewed.

To the patients, according to the selected studies, no risk nor incident was reported

(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,

2008; Yoo et al., 2011). For the potential risk of the implementation of the

intervention without using any analgesics, experience of pain due to venipuncture by

children can be anticipated. However, there are several potential benefits resulting

from the implementation of the innovation as supported by the selected studies,

including the reduction of pain, distress and the successful rate of venipuncture

(Bellieni et al., 2006; MacLaren & Cohen, 2005; Tak & van Bon, 2005; Wang et al.,

2008; Yoo et al., 2011).

For the cost, in the short term, the material cost would be mainly from purchasing the

DVDs. As there are already some cartoon and animation DVDs available in the unit,

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and some of them are bilingual, it is not necessary to purchase a large number of

DVD for the provision of sufficient choices. As the price of cartoon or animation

DVD are mostly around $150, the material cost is estimated to be around $1000. In

the long run, as the maintenance cost of DVD players is already the general

expenditure of the unit, there is no extra maintenance cost added to the

implementation of innovation.

For the nonmaterial cost, it would be the time spent on the briefing sessions, the time

for the evaluation of the innovation and also the anticipated stress of staff for

changing of usual practice.

However, without trying the innovation, by continuing the current practice of

explaining the procedure to children and applying physical restrain, there would not

be any improvement in alleviating the procedural pain and the corresponding physical

and psychological consequences, including the physiological responses and distress

(Inal & Kelleci, 2012; Kennedy, Luhmann & Zempsky, 2008; McCarthy et al., 2010;

Srouji, Ratnapalan & Schneeweiss, 2010; Yoo et al., 2008). As the intervention may

be effective in increasing the success rate of venepuncture. In terms of material

benefits, less consumables such as angiocatheter and alcohol pad will be used for the

procedure. In terms of non material benefits, time for venepuncture may be saved as

the success rate increases, in addition, staff morale may be improved because of the

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satisfaction and also the saving of physical energy for restraining the patient.

As the intervention may contribute to better patient outcome, outweighing the cost

and benefit, the implementation may result in a reduction of health care cost.

In conclusion, the implementation of the innovation is transferable, feasible and

beneficial to the proposed unit. Therefore, an evidence based guideline is proposed

with the support of the selected studies.

3.5 Evidence-based guideline

From the previous section, it illustrated that there is potential for implementing the

intervention in the targeting pediatric unit. An evidence-based guideline is generated

based on the level of evidence and the grades of recommendations from the Scottish

Intercollegiate Guidelines Network (SIGN), with the level of evidence indicated by

1++, 1+, 1-, 2++, 2+, 2-, 3 and 4 as shown in Appendix 4, and the grades of

recommendations indicated by A, B, C, and D as shown in Appendix 5 (SIGN, 2012).

Title:

Implementation of video distraction to alleviate pain and distress of children during

venipuncture

Objectives of the evidence-based guideline:

The objectives of this guideline are

1. to review the evidence from the selected studies for the alleviation of pain and

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distress of children during venipuncture with video distraction

2. to generate an evidence based instructions for the implementation of video

distraction during venipuncture

3. to alleviate pain of children during venipuncture by implementing video

distraction

Target group:

The guideline is for supporting nurses in making the decision for the implementation

of video distraction during venipuncture.

Recommendations:

1. Patient Characteristics

Recommendation 1.1 (Grade A)

Patients are likely to benefit from video distraction during venipuncture if they are

aged between 1 and 9.

Evidence:

Patients of age 1 to 7 were distracted with videos of cartoon and animation and were

less distress (MacLaren & Cohen, 2005)(1+).

Video distraction was effective in the reduction of pain and increasing the successful

rate of venipuncture on patients aged between 8 and 9 (Wang et al., 2008) (1++).

Recommendation 1.2 (Grade A)

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Patients are likely to benefit from video distraction during venipuncture if they have

no altered mental status, such as sedated and confused, or developmental delay in

cognition or visual or auditory senses.

Evidence: Patients benefiting from the distraction in the study have no history of

cognitive developmental delay, visual, auditory deficit, altered mental status or had

treatment of narcotic analgesics (Wang et al., 2008; Yoo et al., 2011) (1++; 2+)

Recommendation 1.3 (Grade A)

Patients are likely to benefit from video distraction during venipuncture if they have

no history of venipuncture within the past 3 months and frequency of venipuncture

more than once per year.

Evidence:

Patients benefiting from the distraction in the study have no history of venipuncture

within the past 3 months. (Wang et al., 2008) (1++)

Patients benefiting from the distraction in the study have no history of frequent

venipuncture for more than once per year. (Bellieni et al., 2006) (1+)

2. Initiation and duration of the intervention

Recommendation 2.1 (Grade A)

Video of cartoon or animation for distraction should be started at least 2 minutes

before starting venipuncture.

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Evidence: In the studies, the video of cartoon or animation had started for at least 2

minutes before venipuncture performed (Bellieni et al., 2006; MacLaren & Cohen,

2005; Wang et al., 2008) (1+; 1+; 1++)

Recommendation 2.2 (Grade A)

The video of cartoon or animation should be continue throughout the process of

venipuncture.

Evidence: Engagement in the distraction is important for distress rated by patients

(MacLaren & Cohen, 2005). (1+)

3. Choices of video

Recommendation 3.1 (Grade A)

Age appropriate animation or cartoon should be used. Cartoon may be provided for

younger children while animation for older children

Evidence: The distraction should be age appropriate in order to be effective (Wang et

al., 2008). (1++)

Recommendation 3.2 (Grade A)

Patients should be provided with choices of video of cartoon or animation before the

initiation of the distraction.

Evidence: Engagement in the distraction is important for distress rated by patients

(MacLaren & Cohen, 2005). (1+)

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4. Environment

Recommendation 4.1 (Grade A)

Venipuncture should be performed in the treatment room which is a quiet

environment for engagement and adherence to the distraction.

Evidence: It is important to ensure patients were engaging and adhering to the

distraction, as the increase of engagement in distraction is related to the reduction of

distress of patients (MacLaren & Cohen, 2005). (1+)

To apply the guideline in the proposed unit, a pilot test scheme will be conducted.

There will be four steps of the scheme including the application of approval and

necessary resources from the administrative staff, the provision of training to frontline

staff, the implementation of the guideline and the evaluation, every step will last for

one month. For evaluation, pain score of children during venipuncture, the success

rate of venipuncture and staff satisfaction will be assessed. The implementation plan

of the guideline will be further discussed in the next chapter.

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Chapter 4: Implementation Plan

After developing the evidence-based guideline, to effectively implement the

evidence-based guideline in the target clinical setting, the implementation plan

comprises the communication plan with potential users and the pilot study plan will

be commenced.

4.1 Identifying the stakeholders

To obtain support from the stakeholders is essential for the implementation of the

guideline. Stakeholders are the administrators, physicians, Advance Practice Nurses

(APNs), Registered Nurses (RNs), phlebotomists and health care assistants.

The administrators, including the Department Operation Manager (DOM) and the

Ward Manager (WM) are responsible for approving the proposed implementation,

providing the necessary resources for commencement of the guideline, and also

arranging duty roster for nurses and health care assistance for attending training

sessions before implementation of the guideline.

Frontline staff including RNs, house officers, medical officers, phlebotomists and

health care assistances, who involve in the process of venipuncture, are potential users

of the implementation. In addition, the APNs are responsible for monitoring and

providing assistance in the implementation process. Their cooperation and compliance

are essential for the implementation of the guideline.

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4.2 Communication Plan

Communication with the stakeholders will be started from the administrative level.

The implementation will be introduced to the WM, and a meeting with WM and

DOM will be held to present on the intervention. After gaining their approval, APNs

will be approached; a 15 minute presentation will be given to them during handover

time in order to introduce the intervention to them and gain their support. Finally,

identical sessions of presentation about the significance and benefit of implementation,

and the detail of the implementation guideline will be arranged with the frontline

staff.

4.3 Communication process and implementation strategies

To initiate the implementation, to obtain approval and necessary resources from the

DOM and WM of the target unit is essential. A proposal with a presentation regarding

the significance and benefits of the implementation will be provided to administrators

with evidentiary support. In addition, the implementation guideline, estimated

manpower and the necessary resources will also be included in the presentation.

After the guideline is endorsed and resources available, APNs will be invited to be

coordinators of the implementation program, and be responsible for monitoring and

providing assistance for the implementation, in order to maintain the compliance of

frontline staff to the guideline.

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To enhance the willingness of frontline staff to implement the guideline and their

compliance to the guideline, training sessions will be provided. To ensure all potential

users are able to receive the training. Identical sessions of training, each last for

30minutes, will be arranged in ward 30minutes before the start of P shift in 3 weeks.

At each training session, a presentation about the significance and benefit of

implementation, the detail of the implementation guideline, choices of video available,

operation of the DVD player and data collection method for evaluation will be

provided. In addition, the soft copy of the guideline will be sent to all potential users

via intranet email for reference. Hardcopies of the guideline will also be available at

nursing station and the treatment room where venipuncture usually undergoes in.

After all training sessions completed, the pilot scheme will be started and lasted for

one month. After the evaluation is completed, the results will be disseminated to

DOM and WM.

4.4 Pilot testing plan

To test the feasibility and acceptability of the implementation, and to examine the

effectiveness of the guideline, a pilot scheme will be commenced in the pediatric unit.

Evaluation will be done at the end of the pilot scheme to review the process of the

implementation of the guideline, and to look into any unexpected difficulty and

problems during the implementation, so as to modify the guideline and facilitate the

implementation of the new guideline in the future. The detail of the pilot test is

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included in the following paragraphs.

4.5 Design of the pilot test

A 3-month pilot test plan will be launched in the target pediatric unit. After a 3-week

training period, front line staff will participate in a randomized control trial of the

implementation which lasts for 4 weeks. Following the implementation period,

evaluation will last for 4 weeks.

During the implementation period, RNs who completed the training are in charge of

the patient requiring venipuncture would pick a sealed envelope in the nursing station

to randomly assign the patient in the intervention group or the control group. Patients

in control group would receive usual care while patients in intervention group would

receive video distraction in accordance with the guideline.

4.6 Subject recruitment

Subject recruitment will be done by RNs as case nurses are familiar with their

patient’s demographic data and medical history, and thus be able to determine

whether the patients are eligible to participate in the study according to the guideline.

Approximately a total of 60 subjects would be included.

4.7 Data collection

Pain score would be assessed by the RN participates in venipuncture procedure and

recorded in the log book with the subject’s demographic data, size of cannula used,

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the times of venipuncture and any adverse events right after the procedure. Visual

Analog Scale (VAS) and Faces Legs Activity Cry Consolability Pain Scale (FLACC)

would be used, training sessions would be provided for nurses to revise on how to

assess pain with the pain scales. As coordinators, APNs would monitor the

compliance of staff in doing the assessment and the documentation of data, and also

provide support of any difficulty encountered.

Besides, opinion would be collected from frontline staff and APNs by collecting

evaluation forms in a box located in the nurse’s station during the pilot test period, in

order to collect data on their acceptability, level of workload, compliances and any

advices for the implementation. Meetings will also be conducted in the ward once a

week to discuss on the difficulty encountered during the implementation and gaining

feedbacks from the users.

4.8 Review of guideline

After the implementation period, the logbook and opinion forms from staff would be

collected for evaluation. After the evaluation, the implementation guideline will be

modified according to the data collected.

4.9 Sustaining the change

With the result of the evaluation, the evaluation report and the modified guideline will

be handed in to WM and DOM, and their approval of the implementation of the

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modified guideline in the proposed unit will be applied.

Chapter 5: Evaluation plan

Evaluation of the guideline is essential to review on its effectiveness and benefit to the

outcomes of patients, health care providers and even the system.

In the following paragraphs, the evaluation plan will be illustrated with the proposed

outcomes, nature and numbers of clients to be evolved, strategies of measurement,

data analysis and basis for an effective change of practice.

5.1 Identifying outcomes

The primary patient outcome for evaluation would be pain score. RNs who are in

charge of the patient and participate in the venipuncture procedure would be

responsible for assessing the patient and documenting the pain score and patient’s

demographic data in the venipuncture record (Appendix 1) pain assessment, Visual

Analog Scale (VAS) and Faces Legs Activity Cry Consolability Pain Scale (FLACC)

would be used (Appendix 2). VAS was widely reviewed as a valid pain assessment

tool for children aged above 3 without developmental delay and mental illness

(Anthony & Schanberg,2007; Crellin, et.al, 2007; Garra et al., 2010; Tomlinson, et.

al., 2010). For those who aged under 3, FLACC Scale for assessing pain by five

observational behavioral components including faces, legs, activity, cry and

consolibility of patient, was proven as reliable and valid. (Crellin, et.al, 2007;

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Tomlinson, et. al., 2010; Bai, Hsu, Tang & van Dijk, 2012; Summers, 2001; Ramelet,

Rees, Mcdonald, Bulsara, & Huijer, 2007). As the pain assessment would be done by

nurses, it is essential to ensure all nurses are able to assess pain of patient correctly

with the VAS and FLACC scale. Before starting the implementation guideline,

training sessions would be provided for nurses to revise on how to assess pain with

the pain scales and the selection of pain scale according to the age.

The secondary patient outcomes would be the success rate of venipuncture. Number

of attempts of venipuncture would be documented in the venipuncture record

(Appendix 1). As it is more difficult to perform venipuncture with a large size of

angiocatheter, size of an angiocatheter used would also be recorded.

Staff satisfaction would be evaluated as the healthcare provider outcome by an

anonymous self-reported survey (Appendix 3). All users of the implementation would

be included in the survey. A 5-point Likert scale ranging from 1 to 5 would be used.

The rating would be given from 1 representing strongly disagree to 5 representing

strongly agree. A mean score would be calculated, and the score would be

proportional to staff satisfaction. In the survey, staff was also encouraged to give

advice on the guideline and express their concerns towards the guideline. The same

survey will be distributed to the ward staff twice at one week time and one month

time after the implementation starts. At one week time, the survey provides

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information on staff satisfaction and problems encountered for members of the

working group to solve the problems. And the survey at one month time would be

compared with the previous survey for any difference in the staff satisfaction and new

problems encountered during the implementation process.

The system outcomes would be the utilization rate of the guideline and cost of the

implementation. The utilization rate would be counted by counting the venipuncture

record. The cost of the implementation would be calculated from the account record

of material cost and maintenance cost, which are kept by the ward secretary and the

ward manager.

5.2 Timing and frequency of data measurement

For the primary and the secondary patient outcomes, they would be measured just

after venipuncture procedure. For the staff satisfaction, data would be collected at one

week time and one month time after the implementation starts. For the utilization rate

of the guideline and the cost, data would be collected right after the implementation

period.

5.3 Nature and number of clients to be involved

The inclusion and exclusion criteria of patients would be the same as the guideline

discussed before. Pediatric patients aged from 1 to 9 would be included, while those

diagnosed to have developmental delay, altered mental status and visual or auditory

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deficits would be excluded.

Previous studies showed significant effect of the implementation on relieving pain of

children undergoing venipuncture (Bellieni et al., 2006; MacLaren & Cohen, 2005;

Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). For data collection, the

design will be the same as in the pilot study. For statistical analysis, a two tailed t test

will be performed to investigate for the reduction in pain level of children. GPower

(2014) was used for calculation of the sample size of the patients. By using effect size

of 0.3 and 95% Power, the sample size was estimated to be 134. From the

Phlebotomist record of the ward, there are approximately 1000 patients aged from 1 to

9 requiring venipuncture in 2013 (Phlebotomist record, 2013), in considerations of

some patients may fulfil the exclusion criteria, approximately 2 months time was

expected to recruit 111subjects. Therefore, a 2 month implementation period would

be required.

5.4 Data analysis

After the implementation period, the data collected would be entered into a computer

database and analyzed with the Statistical Package for Social Science (SPSS) software.

Two tail t-test would be used to investigate for any reduction in the pain score in the

intervention group. Two-tailed t-test would also be used to determine whether the

number of attempts for the venipuncture would be reduced.

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For the staff satisfaction, both data collected one week time and one month time

would be estimated with 95% confidence interval. For the utilization rate of the

implementation, 95% confidence interval would also be used

The cost would be calculated by the sum of the material cost and the miscellaneous

cost, including ink and paper for printing venipuncture record, survey, etc.

5.5 Evaluation on the effectiveness of change of practice

To consider whether the change of practice is effective, effect on reduction of pain

and times of venipuncture, staff satisfaction and utilization rate would be considered.

For the primary outcome, the reduction of pain score of children and times of

venipuncture compared to the current practice would be considered as a significant

indicator for effective change of practice. For the staff satisfaction, result from the

staff survey showing a mean score of 3 out of five of the Likert scale is considered as

supporting the implementation. For the utilization rate, it should be over 70%. With

the evaluation result available, there would be an evaluation meeting with DOM and

WM at the end of the evaluation period to discuss on the result of the data analysis

and to determine whether to continue to adopt the innovation.

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Chapter 6: Conclusion

From the best available evidence, video distraction is reported to have moderate to

strong effect on the alleviation of pain, and also have positive effect on the reduction

of distress and successful rate of venipuncture (Bellieni et al., 2006; MacLaren &

Cohen, 2005; Tak & van Bon, 2005; Wang et al., 2008; Yoo et al., 2011). However, it

has not been implemented for the alleviation of pain of children during venipuncture

in the proposed pediatric unit, which may be due to the lack of evidence based

guideline.

The evidence based guideline in this paper was developed with the support of the best

evidence synthesized from the identified studies, and the implementation potential is

considered to be high in terms of transferability, feasibility and cost.

As venipuncture is a common procedure in the paediatric unit, that there will be a

number of paediatric patients benefited from the implementation of video distraction

during venipuncture. Hopefully the application of the implementation will also be

effective in the pain management and the reduction of distress, and the modified

guideline can become a usual pain management strategy for paediatric patients during

venipuncture in the proposed clinical setting.

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Appendix 1

Searching process

Search Terms PubMed CINAHL British Nursing Index

1 Needle / IV access /

IV cannulation /

venipuncture/

venipuncture

124420 13308 464 (narrowed results

by subject: children:

pain = 28)

2 TV 8435 2363

3 audiovisual 7964 674

4 Visual audio 1974 289

5 cartoon 619 157

6 distraction 10939 2971

7 1+2 68 7

8 1+3 24 3

9 1+4 14 0

10 1+5 5 3

11 1+6 93 68

Studies met

selection criteria

5 3 2

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Appendix 1

Searching the evidence

Items in appendix 1 PubMed CINAHL British Nursing Index

1. 7+8+9+10+11 204 81

2 After screening

titles and abstracts,

and removal of

duplication

8 5

(2 studies

published

in Italian)

2

After reading full

text

5 3

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Citation Study

design

Evidence

Level

Subject

characteristics

Interventions Control Outcome measures Effect size

(Cohen’s d)

Bellieni, C.V., Cordelli,

D.M., Raffaelli, M., Ricci,

B., Morgese, G. &

Buonocore, G. (2006).

Analgesic effect of

watching TV during

venepuncture. Arch Dis

Child, 91(12), 1015–1017.

RCT

+ - Age range:

7-12

- Mean age:

8-9

- Able to use

numeric scale

TV group (n= 23)

- Age appropriate cartoon

- started 120sec before

procedure

- Mother present without

distraction

M group (n = 23)

active distraction (speaking,

caressing, soothing) by mother

n = 23

Mother

present

without

distraction

1) Pain rated by

children

2) Pain rated by

caregiver

Pain scale:

Oucher scale

1) p = 0.037

TV vs C: d = 0.77

M vs C: d = 0.25

2) p = 0.045

TV vs C: d = 0.6

M vs C: d = - 0.09

MacLaren, J. & Cohen, L.

(2005). A comparison of

Distraction Strategies for

Venipuncture Distress in

Children. Journal of

Pediatric Psychology,

30(5), 387-396.

RCT + Age range:

1-7

Mean age:

4.29 (SD=1.8)

two age

groups:

age 1-3;

age 4-7

M group (n = 29)

Cartoon or animation movie

- age 1-3: Teletubbies; age 4-7:

Toy Story 2/ The Little Mermaid

- start 5-7min before procedure

- encourage child’s adherence to

distraction

T group (n = 30) - Interactive toy

- age 1-3: toy robot with buttons

age 4-7 computer games

n = 29

Standard

care with

instruction

to

minimize

distracting

behavior

when

possible

1) Child Engagement in

distraction

2) Child distress by

caregiver-report (VAS)

3) Child distress by

nurse-report (VAS)

4) Child distress by

Self-report (faces scale)

5) Child distress by

Observation (OBSD)

M vs C:

1) p <0.01

2) P<0.01

d = 0.7

3) p = 0.367

d = 0.15

4) p < 0.01

d = 0.9

5) d = 0.5

RCT = randomized controlled trial; n = number of subject; SD = standard deviation; C = control T= toy

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Citation Study

design

Evidence

Level

Subject

characteristics

Interventions Control Outcome measures Effect size

(Cohen’s d)

Tak, J.H. & van Bon, W.H.J.

(2005). Pain- and

distress-reducing interventions for

venepuncture in children. Child:

Care, Health & Development, 32,

3, 257–268.

RCT + Age range:

3-12

I. Placebo, Distraction,

information (n = 20)

II. ELMA, Distraction,

information (n = 21)

Distraction:

6 min fragment of video

cartoon: “ The Beauty &

The Beast”

III. Placebo,

information

(n = 20)

IV. EMLA,

information

( n = 21)

1) Behavioral distress

(Groningen Distress

Scale: breathing,

crying, muscle tone)

2) Self reported pain

Pain scale:

Age < 6: Oucher scale

Age >=6: VAS

1) T2

I vs III: d = -0.18

II vs IV: d = 0.5

2) T3

I vs III: d = 0.5

II vs IV: d = 0.09

p value not

available

Wang, Z.X. , Sun, L.H. & Chen, A.P.

(2008) The efficacy of

non-pharmacological methods of

pain management in school age

children receiving venepuncture in a

paediatric department: a randomized

controlled trial of audiovisual

distraction and routine psychological

intervention. Swiss Med Wkly, 138

(39-40), 579–584.

RCT ++ Age range:

8-9

AV group (n = 100)

- Audiovisual distraction

- 10 appropriate cartoons

- chosen by patients

- Start 3 min before

procedure

P group (n = 100)

- Psychological intervention

scheme (Explain before

procedure, therapeutic

touch, encouragement,

guided imagery)

No special

Intervention

(n = 100)

1) cooperation

2) venipuncture times

3) pain intensity

Pain scale: VAS

AV vs C

1) p = 0.064

2) p = 0.045

3) p = 0.047

d = 0.28

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51

RCT = randomized controlled trial; n = number of subject; C = control; EMLA= Eutectic mixture of local anaesthetics; T2 = just before venipuncture; T3= during

venipuncture; VAS Visual Analog Scale

Citation Study design Evidence

Level

Subject

characteristics

Interventions Control Outcome measures Effect size

(Cohen’s d)

Yoo, H., Kim, S., Hur,

H.K. & Kim, H.S.

(2011). The effects of

an animation

distraction

intervention on pain

response of preschool

children during

venipuncture. Applied

Nursing Research,

24(2), 94–100.

Quasi-

experimental

0 Age range:

3-7

Experimental

group older

than control

group by 10.5

months

A group (n = 20)

3- min animation

downloaded from website

for free

Standard

care

1) self-reported pain

2) behavioral pain

response

3) blood cortisol level

4) blood glucose level

5) Heart rate

Pain scale:

1) Poker chip scale

2) Faces rating scale of

Wong and Baker (1988)

1) p = 0.029; d = 0.72

2) p = 0.002; d = 1.02

3) p = 0.043; d = 0.73

4) p = 0.003; d = 1.01

5) p = 0.809

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S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Bellieni, C.V., Cordelli, D.M., Raffaelli, M., Ricci, B., Morgese, G. & Buonocore, G. (2006). Analgesic effect

of watching TV during venepuncture. Arch Dis Child, 91(12), 1015–1017.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.i

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.ii

Yes

Can’t say

No

1.3 An adequate concealment method is used.iii

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.iv

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.v

Yes No

Can’t say

1.6 The only difference between groups is the treatment under

investigation.vi

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.vii

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was

completed?viii

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).ix

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.x

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? High quality (++)

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Code as follows:xi

Acceptable (+)

Unacceptable – reject 0

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?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The study concludes that cartoon distraction has effective analgesic effect during venipuncture.

Although the sample size is small, the effect size of pain relief rated by children was high. The

intervention is applicable to children aged from 7-12.

i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions.

ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study.

iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%.

iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study.

v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.

vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution.

vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study.

viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study.

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ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study.

x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres.

xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies

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55

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

MacLaren, J. & Cohen, L. (2005). A comparison of Distraction Strategies for Venipuncture Distress in

Children. Journal of Pediatric Psychology, 30(5), 387-396.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.xi

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.xi

Yes

Can’t say

No

1.3 An adequate concealment method is used.xi

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.xi

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.xi Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.xi

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.xi

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was

completed?xi

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).xi

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.xi

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

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56

2.1 How well was the study done to minimise bias? Code as follows:xi

High quality (++)

Acceptable (+)

Unacceptable – reject 0

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?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The study showed significance of cartoon distraction on reducing distress of children during

venipuncture, with large effect size. With verbal pain as one of the components of distress included in

the study, the intervention may also be effective in reducing the procedural pain of children.

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57

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Tak, J.H. & van Bon, W.H.J. (2005). Pain- and distress-reducing interventions for venepuncture in children.

Child: Care, Health & Development, 32, 3, 257–268.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

3. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

4. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.xi

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.xi

Yes

Can’t say

No

1.3 An adequate concealment method is used.xi

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.xi

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.xi Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.xi

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.xi

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was

completed?xi

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).xi

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.xi

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

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58

2.1 How well was the study done to minimise bias? Code as follows:xi

High quality (++)

Acceptable (+)

Unacceptable – reject 0

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?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

Comparing the effect of EMLA cream, the analgesic effect of cartoon distraction was comparatively

less significant. However, looking into the result of the study, when ELMA cream was not used,

cartoon distraction showed moderate effect on pain relief during venipuncture. As EMLA cream is

also not currently used in my clinical setting, the cartoon distraction is an effective strategy for pain

relief.

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59

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Wang, Z.X. , Sun, L.H. & Chen, A.P. (2008) The efficacy of non-pharmacological methods of pain

management in school age children receiving venepuncture in a paediatric department: a randomized

controlled trial of audiovisual distraction and routine psychological intervention. Swiss Med Wkly, 138

(39-40), 579–584.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

5. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

6. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.xi

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.xi

Yes

Can’t say

No

1.3 An adequate concealment method is used.xi

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.xi

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.xi Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.xi

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.xi

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was

completed?xi

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).xi

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.xi

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

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60

2.1 How well was the study done to minimise bias? Code as follows:xi

High quality (++)

Acceptable (+)

Unacceptable – reject 0

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?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The study concludes that video distraction was effective in relieving the pain, improving patient’s

cooperation and successful rate venipuncture. It showed significance of video distraction for pain

control of children aged from 8 to 9.

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61

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Yoo, H., Kim, S., Hur, H.K. & Kim, H.S. (2011). The effects of an animation distraction intervention on pain

response of preschool children during venipuncture. Applied Nursing Research, 24(2), 94–100.

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

7. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

8. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.xi

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.xi

Yes

Can’t say

No

1.3 An adequate concealment method is used.xi

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.xi

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.xi Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.xi

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.xi

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was

completed?xi

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).xi

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.xi

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

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62

2.1 How well was the study done to minimise bias? Code as follows:xi

High quality (++)

Acceptable (+)

Unacceptable – reject 0

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?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The study concludes that video distraction was effective in relieving the pain, improving patient’s

cooperation and successful rate venipuncture. It showed significance of video distraction for pain

control of children aged from 8 to 9.

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63

Appendix 4

Levels of Evidence

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

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64

Appendix 5

Grades of Recommendations

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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65

Appendix 6

Venipuncture Record

Gum Label

Please Tick the appropriate Box.

For Others, please specify.

Ethnicity: □Asian □White □Indian/Pakistanian □Others:___________

Chief Complaint: □Fever □GE □Acute Bronchiolitis □Head injury □Allergy □Others:____________

Size of Cannula: □20GA □22GA □24GA □Others:_______

Location of Cannulation: □Antecubital □Hand □Others:__________

No. of attempts of Venipuncture __________

Pain Scale: Visual Analog Scale/ FLACC Scale

Pain Score:____________/10

Adverse Events: □None □Erythema □Edema

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Appendix 7

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Appendix 8 Satisfactory Survey for Healthcare Providers

Please circle your answer.

Strongly

disagree

disagree neutral agree Strongly

agree

1. I think this implementation can

reduce pediatric venipuncture pain.

1 2 3 4 5

2. I think this implementation do not

place a burden to healthcare providers.

1 2 3 4 5

3. I feel comfortable in doing this

implementation

1 2 3 4 5

4. I support this implementation 1 2 3 4 5

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68

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management in school age children receiving venepuncture in a paediatric department: a randomized

controlled trial of audiovisual distraction and routine psychological intervention. Swiss Medical Weekly,

138 (39-40), 579–584.

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response of preschool children during venipuncture. Applied Nursing Research, 24(2), 94–100.