Abstract of dissertation entitled

“An Evidence Based Guideline of Using Breastfeeding in Reducing Pain of

Neonates During Minor Medical Procedures”

Submitted by

Law Lik Ching

for the degree of Master of Nursing

at the University of Hong Kong

in August 2015

Heel prick and venepuncture are the most common minor painful procedures for

neonates during hospitalization. Evidence showed that neonates have increased

sensitivity to pain. As neonates are too young to communicate, prevention of

minor procedure pain becomes a challenging part of neonatal care.

Pharmacological interventions are seldom used for minor medical procedure due

to the concerns of their effectiveness and the potential adverse effect. Therefore,

different non-pharmacological methods were investigated to minimize minor

medical procedure pain. Breastfeeding and breast milk were proven to be effective

non-pharmacological interventions in relieving pain during heel lance and

venepuncture.

The objective of this dissertation is to conduct a literature review on currently

available studies regarding breastfeeding or breast milk in minimizing minor

procedure pain in neonates less than one month old. The method of adopting

breastfeeding or breast milk as analgesic, the selection of eligible participants, and

the transferability of the overseas studies to Hong Kong clinical setting and

feasibility of adopting the innovation to local setting were discussed. An

evidence-based guideline of using breastfeeding or breast milk during minor

medical procedure was also constructed accordingly to the current state of

evidence.

A communication and implementation plan, from identifying the stakeholders to a

pilot testing was outlined in this dissertation. Lastly, evaluation of patient,

healthcare provider and system outcomes were also recommended.

An Evidence Based Guideline of Using Breastfeeding in Reducing

Pain of Neonates During Minor Medical Procedures

by

Law Lik Ching

B. Nurs. (Hons) HKU

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong.

August 2015

i

Declaration

I declare that the dissertation thereof represents my own work, except where due

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

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

degree, diploma or other qualifications.

Signed………………………………………………..

Law Lik Chng

ii

Acknowledgements

I would like to express my deepest gratitude to my supervisors Dr. Wang Man Ping,

Kelvin for his guidance and assistance in the processes of writing this dissertation. I

am greatly beholden to my co-supervisor, Dr. Janet Wong Yuen Ha, for her

encouragement and enlightenment. This dissertation could not been completed

without their generous support.

I would like to take this opportunity to thank the Hospital Authority for providing

partial sponsorship in my application of the Master of Nursing program at the

University of Hong Kong.

I would like to thank the Queen Mary Hospital Paediatric Intensive Care Unit ward

manager Ms. Lee Sze Wai, Josephine for her professional advice and providing me

opportunity in attending the breastfeeding counselling course.

Finally, I would like to thank my family, friends and colleagues for their

understanding and support throughout my study.

iii

Table of Contents

Declaration .................................................................................................................................

i

Acknowledgements .................................................................................................................... ii

Table of contents .......................................................................................................................

iii

Chapter 1: Statement of the Problem ....................................................................................

1

Background ................................................................................................................................

1

Affirming the Need ....................................................................................................................

2

Objectives and Significance .......................................................................................................

4

Chapter 2: Review of Evidence ...............................................................................................

6

Search and Appraisal Strategies .................................................................................................

6

Results ....................................................................................................................................... 8

Description of Studies ................................................................................................................

9

Summary and Synthesis ...........................................................................................................

13

Synthesis of the Evidence ........................................................................................................

17

Implications for Practice ..........................................................................................................

19

Chapter 3: Implementation Potential ..................................................................................

20

Target Population and Setting.................................................................................................. 20

Transferability of the Findings ................................................................................................ 20

Feasibility ................................................................................................................................ 22

Cost-Benefit Analysis of the Innovation ..................................................................................

25

Chapter 4: Evidence-based Practice Guideline .................................................................. 27

Overview of Guidelines ...........................................................................................................

27

iv

Recommendations ................................................................................................................... 28

Chapter 5: Implementation Plan ..........................................................................................

31

Communication Plan ............................................................................................................... 31

Initiating the Changes ..............................................................................................................

33

Sustaining the Change Process ................................................................................................

33

Pilot Testing .............................................................................................................................

34

Chapter 6: Evaluation Plan ...................................................................................................

37

Intervention Outcomes and Outcome Measurements ...............................................................

37

Nature and Number of Clients Involved ..................................................................................

38

Data Analysis and Evaluation ................................................................................................. 39

Criteria for Effectiveness .........................................................................................................

39

Conclusion ...............................................................................................................................

40

Appendices ...............................................................................................................................

41

References ................................................................................................................................

61

1

Chapter 1: Introduction

Pain is defined as “an unpleasant sensory and emotional experience associated

with actual or potential tissue damage” (AAP, 2000). Evidence showed that

anatomical systems for pain stimuli are well developed by mid-to-late second

trimester and the physiological responses of painful event in neonates are similar to

those of adults (Shah, V. & Ohlsson, A. A., 2004). However, pain management in

neonates is far from adequate (AAP, 2000). It is difficult and challenging for medical

professional to authentically evaluate and manage pain in neonates due to their

inability to verbalize pain. Therefore, it is our responsibility to monitor and minimize

the adverse effects brings by painful stimuli. Recent studies have shown that

breastfeeding and breast milk are effective in minimizing minor procedure pain in

neonates. The purpose of this paper is to synthesize the evidence from literatures and

to develop an evidence based guideline of using breastfeeding for pain reduction in

neonates.

Background

Pharmacological intervention is given to neonates after major painful event such

as post-operation. However, neonates transient undergo minor painful procedures such

as heel lance and venipuncture without analgesic. Not until recently, sucrose

administration was widely studied and proven to be effective and frequently used as

one of the non-pharmacological interventions for minor pain in newborn babies in

clinical setting. However, the side effect of accumulated dose is still not known

(Holsti & Grunau, 2010). Breastfeeding, a natural process, also provides sweet favor

and other effective components of non-pharmacological intervention should be

considered in clinical setting and an evidence based protocol of using breastfeeding as

2

analgesic should be set up.

Affirming the Need

It is inevitable for neonates to prevent painful procedure since birth, such as

vitamin K injection, vaccination and routine blood taking by heel prick or

venipuncture. If pain is not well managed, it will create immediate physiological

(increase in heart rate, breathing, blood pressure and decrease in oxygen saturation)

and behavioral impacts (change in facial expression, crying, activity of body and sleep

disturbances) (Holsti, Grunau, Oberlander, & Whitfield, 2004), as well as long-term

consequences (altered pain response in later infancy) (Grunau, Holsti, & Peters, 2006).

Therefore, it is important to provide effective pain preventive measure promptly

before minor medical procedures.

Both breastfeeding and breast milk were proven to reduce pain in healthy term

baby during heel lance by 80-90%, which is more potent than sweetening solutions

without side effect (Gray, Miller, Pillipp, & Blass, 2002; Weissman, Aranovitch,

Blazer, & Zimmer, 2009).Breastfeeding minimize minor pain by providing sweet taste,

skin-to-skin contact, and sucking. On the other hand, breast milk contain high fat

content, which has antinociceptive effect that calming a baby during minor pain

(Blass & Shide, 1994).

Breastfeeding can divert neonates from painful stimuli (Gunnar, 1984). In

addition, the sweet taste of breast milk and sucking during breastfeeding reduces

stress because more energy saved from crying (Rao, Blass, Brignol, Marino, & Glass,

1997). Skin-to-skin contact between mother and baby increase maternal bonding,

improves cardio-respiratory stability and decrease sleep disturbances of baby and

making baby more easy to adapt to new environment (Carbajal, Veerapen, Couderc,

Jugie, & Ville, 2003).

3

In addition to the effective components of breastfeeding, the Hong Kong

Committee for UNICEF formed the Baby Friendly Hospital Initiative Committee in

1992, to promote and support breastfeeding in Hong Kong (Unicef, About the Hong

Kong association, 2014). Since 2013, there were three hospitals in Hong Kong

registered the intent of becoming baby friendly hospital (Unicef, Healthcare facilities,

2014). Although giving sucrose in Hong Kong is not contraindicating to the

international code of marketing breast milk subsidies, however, the use of sweet

solution such as sucrose may intervene with a start of correct breastfeeding (Howard,

et al., 2003). Encouraging the use of breastfeeding or breast milk matches the

hospital policy of avoiding pacifiers in breastfeeding newborn. Besides, encourage

breastfeeding as analgesia also reinforces mothers that they can take up a role in

soothing their babies suffering from pain.

Furthermore, the prevalence of breastfeeding in Hong Kong is in an increasing

trend. According to the Baby Friendly Hospital Initiative Hong Kong Association

(BFHIHKA) (2013), the breastfeeding rate in 2012 from all public and private

hospitals was 85%, which was an increase of 2.5% over the 83.3% for births in 2011.

This can explain by the mothers’ awareness of the choice of the food for their babies

and the effective propaganda of the association. Therefore, it is inevitable to develop

an evidence based practice of using breastfeeding or breast milk as analgesia.

With the clinical issue discussed above, the research question and PICO

formulated to the identified issue are as below:

Is breastfeeding or breast milk effective in reducing minor procedure pain in

neonates?

P: Healthy full term neonates without congenital abnormality or disease

I: Breastfeeding or providing breast milk during and/or before painful

4

procedures

C: Current practice of using sucrose and/or use of placebo

O: Pain reduction during minor procedure

Objectives and Significance

Objectives of study

i. To identify relevant literatures according to the research question and PICO.

ii. To critically appraise the selected literatures

iii. To summarize and synthesize the evidence from the selected literatures.

iv. To apply the reviewed evidence and to develop an evidence-based practice

protocol for using breastfeeding as analgesic.

v. To develop evidence based guideline for implementing and evaluating the

effectiveness of applying breastfeeding as analgesic.

vi. To examine the implementation potential of applying breastfeeding or breast

milk in pain control for neonates.

Significance of study

Neonates routinely experience pain for various invasive procedures, such as heel

lance or venipuncture. Untreated pain has immediate and measureable negative

physiological effects, besides it also causes anxiety and stress to neonates as well as

parental distress (Reis, Roth, Syphan, Tarbell, & Holubkov, 2003). Study by Slater et

al. (2006) showed that newborn infants are more sensitive to pain and they react more

vigorously to pain than older children and adults, and are more vulnerable to the long

term adverse effects brings by pain. According to Anand (2000), poorly managed pain

in preterm infants may cause permanent alteration in brain processing and

maladaptive behavior later in life. Pain may also alter an infant’s ability to learn as

well as remember new information. In a study carried out by Simons et al. (2003)

5

showed that neonates in NICU received an average of 14±4 painful procedure in their

first 14 days of hospital stay. Many studies have investigated the efficacy of

non-pharmacological interventions, such as sweet solution that stimulate endogenous

opioid receptors to produce analgesia (Skogsdal, Eriksson, & Schollin, 1997). On the

other hand, the analgesic effect of nonnutritive sucking and skin-to-skin contact are

mediated by the nonopioid pathways of oropharyngeal tactile and mechanoreceptor

stimulation (Blass, Shide, Zaw-Mon, & Sorrentino, 1995). Studies have shown that

breastfeeding have equivocal analgesic effect as it combines all nonpharmacological

analgesic components: sucking, maternal infant contact, and sweet taste. Therefore,

this paper is to summary and synthesis the evidence of the selected studies and to

make an evidence based protocol.

Moreover, in view of the readability and medication cost expenditure,

breastfeeding and breast milk are natural, simple and non-invasive pain reduction

method when compared to sucrose solution. In Hong Kong, sucrose is not readily

available, instead of dispensing by the hospital authority pharmacy, it is purchased by

individual department. A bottle of 15ml 24% sucrose is > HKD20, besides, it is an

effective media for microorganism to growth, therefore they need to freshly prepare

every day. In current practice, a nurse is designated to prepare the sucrose solution

daily. She/he will aspirate 0.5ml sucrose into syringes and the number of sucrose

prepare varies depending on clinical situation. However, not all the prepared sucrose

would be consumed, therefore many were discarded and wasted. In addition, there is

no standard guideline for sucrose preparation, as our study population is susceptible to

gastrointestinal infection, therefore the cleanliness of prepared sucrose would be a

problem. In contrary, breastfeeding is readily available in the presence of mother

without any cost and frozen breast milk can keep for a longer time, so we should

6

encourage the use of breastfeeding or breast milk as analgesia in clinical setting.

7

Chapter 2: Critical Appraisal

In this chapter, literatures of using breastfeeding or breast milk in minimizing

procedure pain are systematically critique. Searching and appraisal strategies for

relevant literatures are described, quality of studies is assessed, and the summary of

the data is discussed.

Search and Appraisal Strategies

I. Inclusion criteria

The criteria set for considering journals for review are based on four major areas:

1. Types of studies, 2. Types of participants, 3. Types of interventions, and 4. Types

of outcome measures.

1. Types of studies: All randomized trials or quasi-randomized controlled trials

of breastfeeding or breast milk given orally were considered.

2. Types of participants: Term neonates with gestational age ≥ 37 weeks and

postnatal age not more than a month, of either sex and in-hospital patients,

undergoing heel prick or venepuncture or vaccination were considered.

3. Types of intervention: Breastfeeding or breast milk given before and/or during

procedure compared to other non-pharmacological intervention or placebos

were considered.

4. Types of outcome measurement: Physiological parameter such as changes in

heart rate, duration of crying; and various validated pain scale.

8

II. Exclusion criteria

Premature neonates, extremely low birth weight (<1000g), neonates with

congenital problem or receiving sedation were excluded in our study.

Search Strategies for the Identification of Studies

I. Search strategies

Literature search was started from August 2014 to September 2014 via three

electronic databases. They were PubMed, CINAHL Plus (EBSCOhost) and Ovid

MEDLINE(R). The keywords used were “breastfeeding”, “breast feeding”,

“breast-feeding”, “breast milk”, “newborn”, “infant newborn”, “neonate”, “analgesic”,

“analgesia”, “pain”, “heel lance”, “heel stick”, “heel prick”, “venipuncture”,

“injection”, ”immunization”, ”vaccination”. The papers were limited to English

language and all publications regardless of publishing time were included. The search

results were summarized in table form in Appendix 1.

II. Appraisal strategies

To appraise the quality of evidence in selected studies, the Scottish

Intercollegiate Guideline Network (SIGN) was used. Methodological checklist 2 of

SIGN for controlled trial was chosen because all of the selected papers were

randomized controlled trials. The level of evidence was then rated according to the

coding system of SIGN.

According to methodology checklist 2, the internal validity of randomized

controlled trials was assessed according to the following factors:

9

1. Suitability and clearness of the research questions

2. Method of randomization

3. Method of concealment

4. Blinding of subjects and investigators

5. Similarity of treatment and control groups

6. Treatment provision

7. Clarity of outcome measures

8. Dropout rate

9. Intention to test analysis

10. Multisite comparability

Results

Search results

One hundred and seven, six, and seven articles were retrieved from PubMed,

CINAHL and Ovid MEDLINE(R) respectively. Simple selection was made by

assessing the title and abstract of journals. Thirty-three studies were found, nineteen

of them were duplicated papers from different databases. And seven were excluded

from our study due to their participates are too old to investigate in our study (Dilli,

Kucuk, & Dallar, 2009; Goswami, Upadhyay, Gupta, Chaudhry, Chawla, & Sreenivas,

2013), outcome measures stressed on crying time and physiological data only

(Phillips, Chantry, & Gallagher, 2005) , no explanation to randomization methods

(Ors, Baysoy, Cebeci, Bilgen, Turkuner, & Basaran, 1999; Ozdogan, Akman, Cebeci,

Bilgen, & Ozek, 2010; Modarres, Jazayeri, Rahnama, & Montazeri, 2013) and

duplication of same data of Bilgen, Ozek, Cebeci, & Ors (2001) study. Finally, seven

studies matched our inclusion criteria and full texts were then obtained for systematic

10

review. The papers inclusion and exclusion result was shown as a flow chart and

attached in Appendix 2. Data of these studies were summarized in a form of table of

evidence in Appendix 3. The methodology checklists for the selected papers were

attached in Appendix 4, the results of quality assessment were summarized in a table

form and attached in Appendix 5. The study characteristics and methodologies used in

the selected journals were summarized and described in the following sections.

Description of Studies

Study design

Five studies are randomized controlled trials ( Bilgen, Ozek, Cebeci, & Ors,

2001; Carbajal, Veerapen, Couderc, Jugie, & Ville, 2003; Codipietro, Ceccarelli, &

Ponzone, 2008; Marín Gabriel, et al., 2013) and two studies are quasi-randomized

controlled trial (Altun-Koroglu, Ozek, Bilgen, & Cebeci, 2010; Upadhyay, et al.,

2004). However, due to the randomization method and unblinded nature of the

intevention, certain extent of bias existed and the papers were graded according to the

SIGN grading system as 1++, 1+, or 1- depending on the level of bias as Appendix 6.

Demographic characteristics

All of the selected studies were carried out in hospital settings and all of them

were single site studies. One conducted in postnatal wards (Upadhyay et al., 2004),

one carried out in newborn nursery (Uyan et al., 2005), two conducted their studies in

neonatal units (Codipietro et al., 2008; Altun-Koroglu et al., 2010), three of them

conducted in maternity wards (Carbajal et al., 2003; Bilgen, et al., 2001; Marín

Gabriel, et al., 2013). Four studies conducted in developing countries, like India

(Upadhyay et al., 2004; ) and Turkey (Altun-Koroglu, Ozeket al., 2010; Bilgen et al.,

11

2001; Uyan et al., 2005) and Iran (Modarres et al., 2013), and three conducted in

developed counties, like Italy (Codipietro et al., 2008) , France (Carbajal et al., 2003)

and Spain (Marín Gabriel, et al., 2013)

Characteristics of population

A total of 985 healthy full term neonates with gestational age ≥ 37weeks and

postnatal age ranged from 24hous to 1 month were included in the seven studies. The

charateristics of the study participants were similar in all the studies. All of the seven

studies recruited newborn infants with apgar score at least ≥7 at 1min of birth and

birth weight >2.3kg.

In addition, only two studies exclused babies born under GA or had drug

exposure (Codipietro et al.,2008; Modarres et al.,2013), while others did not.

Randomization

Uyan et al. (2005) study was a quasi-randomization which depended on number

or day of procedure. Other six studies were randomized controlled trial. In

Altun-Koroglu et al. (2010) study, quasi-randomization was used by the researchers.

In study by Bilgen et al. (2001), Carbajal et al. (2003) and Marin Gabriel et al. (2013),

radomization was done by drawing sealed envelops. Computer radom number

generateor was used in Codipietro et al. (2003) an Upadhya et al. (2004)

Blinding

Regarding to blinding to the intervention, in study by Carbajal et al. (2003), it is

impossible to blind the intervention as breastfeeding, held in mothers arms involved

throughtout procedure. Similar to Carbajal et al.(2003) study, breastfeeding

12

throughout the procedure and made masking of intervention not pissible in study by

Codipietro (2008), but masking to outcome measure (cry behaviour) was possible as

the data was analyed by two research assisants who repsonsible for audio tape

listening. In study by Bilgen et al. (2001), procedure performers were masked to the

intervention as placebo was used and heel prick was done one minutes after giving the

testing solution. Intervention analyser were masked to the treatment method too. In

Upadhyay (2004) study, an independent investigator not involved in data analyse and

observation administered the testing solution, therefore masking to observer was

possible. In Uyan et al. (2005) study, outocome measure was blinded. People who

took the video for NCS coding and data investigators were blinded to the treatment

allocation. Study by Marin Gabriel et al. (2013), the parents and procedure performers

were masked to the radomization group, however as breastfeeding involved, so they

were not masked to treatment assignment. In study carried out by Altun-Koroglu et al.

(2010), the researchers were masked to the intervention allocation.

Outcome measures

Outcome measures were clearly stated in all the five studies. Study by Owens &

Todt (1984) showed that heart rate increase when pain intensity increases. Therefore,

heart rate is thought to be one of the mehtods of measuring pain in neonates. Neonates

do not able to express themselves in words, therefore crying is one of the

communication methods for them. Studies showed that crying time is regarded as one

of the sensitive methods for pain assessment (Ramenghi, Wood, Griffith, & Levene,

1996). Craig (1992) study found that facial expression was the most reliable indicator

of pain. In the selected studies, different pain scale was used and faical expression

was one of the components in the scales.

13

In Marín Gabriel, et al. (2013) used Neonatal Infant Pain Scale (NIPS), which is

a reliable and valid scale used for assessing behavioral changes before, during and

after intrusive procedures in both full term and preterm neonats. It composes of six

categories: limbs movements, breathing pattern, facial expression, cry and state of

arouseal. With highest score 7 as sever pain and 0 as no pain (Lawrence, Alcock, &

McGrath, The development of a tool to assess neonatal pain, 1993).

In Codipietro et al. (2008) study, they used Premature Infant Pain Profile (PIPP)

for evaluating pain. PIPP is a valid and widely utilized 7-indicator pain assessment

tools for pain assessment in both preterm and term infants. It includes compontents of

gestational age, behavioural state, physiological datas and facial expressions. With

highest score of 21 as maxium pain and 0 as no pain (Ballantyne, Stevens, McAllister,

Dionne, & Jack, 1999).

Neonatal Facial Coding System (NFCS) was used in Altun-Koroglu, Ozek,

Bilgen, & Cebeci (2010) studies. NFCS evaluate pain in preterm and full term

newborns infants by monitoring facial actions with highest score 9 for sever pain and

0 for no pain. (Grunau & Craig, 1990), and a modified NFCS was used in Upadhyay,

Aggarwal, Narayan, Joshi, Paul, & Deorari (2004) study by adding limbs movements

into account.

Douleur Aiguë Nouveau-né behavioural scale (DAS) used for assessing acute

pain in newborn infants was used in Modarres et al.(2013) study. It consits of three

items: facial expresssions, limbs movements and vocal expression with 0 as no pain

and 10 as maximum pain (Carbajal, Paupe, Hoenn, Lenclen, & OlivierMartin, 1977).

14

In Bilgen, Ozek, Cebeci, & Ors (2001) study, Infant Body Coding System( IBCS)

was used. It is a unidimentional pain scale which consists of 6 discrete variables

including limbs and torso movements (Craig, Whithfield, Grunau, Linton, &

Hadijstavropoulous, 1993).

Summary and Synthesis

Summary of data

Seven studies were used in our present review including five randomized

controlled trials and two quasi-randomized controlled trials. Three studies evaluated

breastfeeding (Altun-Koroglu et al., 2010; Codipietro et al., 2008; Carbajal et al.,

2003), three studies evaluated supplemental breast milk (Ors et al., 1999; Bilgen et al.,

2001; Uyan et al., 2005; Altun-Koroglu et al., 2010) and one study evaluated both

breastfeeding and supplemented breast milk versus placebo and sucrose (Bilgen et

al.,2001). Studies by Altun-Koroglu et al. (2010), Uyan et al. (2005), Bilgen et

al.(2001), Codipietro et al.(2008) and Marin Gabriel et al. (2013) used heel lance or

heel pricks as their minor painful procedure, while the remaining two took

venipuncture (Carbajal et al., 2003; Upadhyay et al.,2004) as painful event.

Among these studies, studies of Carbajal et al. (2003), Upadhyay et al. (2004),

Codipietro et al. (2008), and Marin Gabriel et al. (2013) suggested that breastfeeding

has superior analgesic effect in pain control for neonates during minor painful event.

However, studies by Bilgen et al. (2001) and Uyan et al. (2005) could not detect

statistical importance of breast milk in minimizing minor pain in neonates. In one

study by Altun-koroglu et al. (2010) who compared breast milk with sucrose in

minimizing pain and showed sucrose was slightly better than breast milk, nonetheless

15

they also suggested that breast milk could be used as an alternative analgesia for

neonates.

In the breastfeeding versus control studies, three of them used the percentage of

heart rate change as one of the outcome measures. In study by Marin Gabrie et al.

(2013) showed that the percentage of crying time was shorter when compare to

sucrose group (MD=-2) and a significant difference was found when compared to

skin-to-skin group (MD=-49). In Codipietro et al. (2008) study, the percentage of

heart rate change was significant lower in breastfeeding group when compared to

sucrose group at 2 minute and during blood sampling (MD=-29 and -25 respectively).

However, in study by Bilgen et al. (2001), the percentage of heart rate was longer than

sucrose group (MD=27 at 1 min, MD=10 at 2minute and MD=21 at 3 minute), and no

significant difference when compared to placebo (MD=16 at 1min, MD=-5 at 2

minute and MD=3 at 3 minute).

Breastfeeding versus control studies

Three studies reported crying time. In Codipietro et al. (2008), percentage of

crying time at 2 minute was significantly lower in breastfeeding group when

compared to placebo (MD=-29). Marin Gabriel et al. (2013) study also reported a

significant lower percentage of crying time during procedure when compared

breastfeeding to other interventions, such as sucrose plus skin to skin (MD=-2), skin

to skin only group (MD=-49) and sucrose only group (MD=-20). In Marin Gabriel et

al. (2013) study, the crying time was also shorter in breastfeeding to other intervention

(MD=-3, MD=-24 and MD=-11 respectively). However, in Bilgen et al. (2001) study,

the crying time was only shorter when compared to placebo (MD=-1) but longer when

compared to sucrose (MD=15).

16

Four different pain scales were used. PIPP, NIPS and IBCS are validated pain

scales. DAN, a non-validated pain scale was used in Carbajal et al. (2003) study, they

used PIPP simultaneously to raise the cogency of the results.

In Carbajal et al. (2003) and Codipietro et al. (2008) studies, the PIPP were used.

In study by Carbajal et al. (2003) when compared breastfeeding to placebo or to held

in mothers’ arms, the pain score was significantly lower (MD=-6 and MD=-7

respectively). The PIPP score was higher when compared to the glucose group to

breastfeeding group (MD=-1) (Garbajal et al., 2003) but lower when compare sucrose

group to breastfeeding group (MD=-5) (Codipietro et al., 2008).

In study by Marin Gabriel et al. (2013), the NIPS was used. The NIPS scores

were similar when breastfeeding compare between different groups before and 2

minute after procedure (MD=-1). However, there was relatively significant different

between breastfeeding to skin-to-skin and sucrose only groups during sampling

(MD=-3).

The IBCS was used in Bilgen et al. (2001) study. The IBCS score was not

significant when comparing breastfeeding to placebo or 25% sucrose (MS=-0.5 and

MD-2 respectively).

The DAN score was used in Carbajal et al. (2003) study. When comparing

breastfeeding group to placebo group the DAN scores was lower (MD=-6) and the

DAB score was also lower when comparing breastfeeding to held in mothers’ arms

group (MD=-7). However, there was no difference between breastfeeding and glucose

group.

17

Breast milk versus control studies

Heart rate change was mentioned in three studies. In Bilgen et al. (2001) study,

heart rate increase in the expressed breast milk group was higher in the 25% sucrose

group (MD=15). Upadhyay et al. (2004) also mentioned heart rate change in their

study, heart rate was significantly lower in expressed breast milk group when

compared to placebo group (MD= -9 immediately after procedure, MD=-12 at 1min

after procedure and MD=-16 at 3 minute after procedure). In study by Uyan et al.

(2005), the percentage change of heart rate in hindmilk is significantly lower when

compared foremilk to placebo (MD=-8.8 and -8.6 respectively), but there was no

significance between foremilk and placebo (MD=0.2).

In Altun-Koroglu et al.(2010) study, they reported the duration of tachycardia

instead of heart rate change, but the duration of tachycardia was significantly shorter

in hindmilk milk group when compared to placebo (MD=-60) but longer in sucrose

group (MD=10).

Four studies reported the duration of crying time. In Altun-Koroglu et al. (2010)

and Bilgen et al.(2001) studies, the crying time in expressed breast milk were longer

when compare to sucrose(regardless of the their concentration) (MD=84 and MD=26

respectively). In Altun-Koroglu et al.(2010) and Upadhyay et al.(2004) study, duration

of crying time was shorter in breastfeeding group when compared to placebo

(MD=-79 and MD=-71). Uyan et al. (2005) studies also reported hindmilk group had

a significant shorter crying time when compared to placebo group (MD=-79 and

MD=-8 respectively). However, the crying time was reported longer in Uyan et

al.(2005) study when comparing foremilk to placebo (MD=9).

18

Take pain score into account, three studies used NFCS and one of which used a

modified scale and data only collected from selected part of the scale (Upadhyay et al.,

2004). In Upadhyay et al. (2004) study showed that the NFCS scores were lower in

the expressed breast milk group when compared to placebo group (MD=-2). In studies

by Uyan et al. (2005) and Altun-Koroglu et al. (2010), the NFCS score was also lower

when comparing expressed breast milk to placebo (MD=-0.5 MD=-1.52 respectively).

However, data of Upadhyay et al. (2004) study was not combined because they used a

modified scale. In Bilgen et al (2001) study the IBCS was used. The score was higher

when compared to sucrose (MD=2) but lower when compared to placebo (MD=-0.5).

Synthesis of Evidence

Breastfeeding is effective in minimizing pain among neonates during painful

procedure. On the contrary, breast milk is not as effective as breastfeeding in pain

reduction. Nevertheless, it is suggested that breast milk could be used as analgesia

for neonates for its safe and non-invasive nature.

Characteristics of selected studies

In the selected studies, the demographic data of the population was similar. The

delivery method varied, study of Uyan et al. (2005), Bilgen et al. (2001), Carbajal et

al. (2003) and Codipietro et al.(2008) included infants born with cesarean section and

Altun-Koroglu et al.(2010) did not mentioned about delivery methods, while the

remaining two excluded babies born under general anesthesia (Upadhyay et al.,2004;

Marin Gabriel et al., 2013). It is not know that the effect of anesthesia used in during

labor in the study outcome.

In Codipietro et al. (2008) and Marin Gabriel et al. (2013) studies, mothers

started breastfeeding before and were allowed to continue to breastfeed their babies

during sampling and they were allowed to talk to or touch their babies whenever they

19

want. However, in Bilgen et al. (2001) study, breastfeeding just started two minutes

before procedure and was suspended during procedure and mothers were not allowed

to talk or touch their babies. These may contribute to the higher percentage of heart

rate change and longer crying time due to lack of environmental and behavioral

stimulation.

In Marin Gabriel et al. (2013) studies, the pain scores were lower in the

breastfeeding group when compared to the skin-to-skin group as well as to other

interventions, because the skin-to-skin contact provided warmth to baby from mother,

maternal heart sound and odor (Lundington-Hoe & Swinth, 1996). Besides, the

postgastric antinociceptive effect form breast milk and its fat content (Weller &

Feldman, 2003). All these factors were effective in soothing neonates.

For expressed breast milk, Uyan et al. (2005) and Altun-Koroglu et al. (2010)

compared hindmilk to placebo for analgesic effect and showed that hindmilk was

effective in minimizing percentage of heart rate change. It can be explained that

hindmilk have 2-3 fold higher fat content than foremilk (Valentine, Hurst, &

Wertheim, 1994) , and which was suggested that the antinociceptive effect of milk

was related to its fat content (Blass & Shide, 1994).

In study by Altun-Koroglu et al.(2010) study, they administed repeated does of

hindmilk to participans, therefore it improved the analgesc effect of expressed

breastmilk and the tachycardia duration was shorter than palcebo group.

In Upadhyay et al.(2004) study, they did not separate the expressed breast milk

into hindmilk or foremilk, but they administer a realtively larger amount of 5ml

expressed breast milk to neonates when compared to other studies which only

commenced 1ml and 2ml to participants, this was believed that the larger volume also

20

play a role in analgesic effect for neonates during minor painful procedure when

compared to placebo.

Implication for Practice

Pain prevention intervention should be provided to neonates during minor

painful procedure. Howeve, pharmacological methods are not suitable for minor,

acute, repetitive and short lasting procedure. Therefore non-pharmacological

intervention is an alternative. Breastfeeding and breastmilk which are non-invasive,

natural and feasible ways showed to have superior effect in mininzing pain in

neonates should be provided in clinical setting.

21

Chapter 3: Implementation Potential

This chapter we will investigate the transferability of the existing evidence

into local clinical settings. To transfer the evidence to the existing local settings, it is

essential for us to compare the similarity between the proposed settings with that in

the selected studies. Besides, the feasibility of applying new practice to a clinical

setting and cost-benefit ratio of the innovation was discussed. An organized and

user-friendly guideline was developed to facilitate the utilization of existing evidence.

Target Population and Setting

The target setting is a Special Care Baby Unit (SCBU) within a Pediatric &

Neonatal Intensive Care Unit of a regional acute hospital. The target hospital is one of

the largest public and university teaching hospitals in Hong Kong. As a tertiary center,

SCBU of this hospital is not only responsible for taking care of the inborn neonates, it

also accepts referrals from other public and private sectors. There are 35 SCBU beds

for babies with sub-acute illnesses and the admission is around 2800 per year.

The target population is healthy babies aged less than one month old who were

previously discharged home but were referred back to SCBU and readmitted for

neonatal jaundice, requiring blood taking by heel lance or venipuncture and allow

milk as tolerated after physical examination.

In current practice, blood taking in SCBU is performed by medical officers,

experienced nurses, or trained phlebotomists through heel prick or venipuncture.

Usually 0.5ml oral sucrose is given to neonates 2 minutes prior to procedure. A

maximum of two additional doses can be given during the procedure if necessary.

Transferability of the Findings

Three of the selected studies were conducted in developed countries. Therefore,

to a certain extent, the studies can be applied to the targeted setting as the target

22

setting population have a high literacy rate, which is an important step in setting up

the protocol.

In addition, the studies were carried out in full term neonates aged zero day to

one month old, without congenital abnormalities, who underwent routine blood taking

through heel lance and venipuncture in postnatal wards, newborn nurseries, neonatal

units and maternity wards. This is similar to our target settings and audience that only

healthy full term neonates with sub-acute medical problems who are undergoing

minor painful procedure will be included.

The philosophy of care is another element in transferability. The philosophies of

care in the target SCBU are to cure with empathy, to care with expertise and to serve

with excellence. Pain management is easily neglected in this vulnerable population as

they are unable to verbalize their needs and feelings. The nurses working in the target

SCBU already heightened their awareness in minimizing procedure pain in neonates

by using 24% sucrose. The proposed intervention shares the same philosophy of care

but uses breastfeeding or breast milk instead. In addition, it uses less cost and more

convenient to use than the current practice. Therefore the nurses in the target setting

should be receptive to the proposed innovation.

Benefit sufficient clients

Neonatal jaundice is one of the most common neonatal medical problems in

SCBU, and the admission rate of neonatal jaundice to the target SCBU is around 500

per year in the target setting. To confirm the diagnosis of neonatal jaundice, blood

sample will be taken by heel prick or venipuncture. As sucrose may intervene with

correct breastfeeding (Howard et al., 2003) and the baby friendly hospital policy,

breastfeeding prevalence increased. More and more mothers request to breastfeed

their babies exclusively. Therefore, many clients, including babies and mothers can

23

benefit from the proposed innovation.

As the target audience is similar to the studies we reviewed, and a large

number of patients can be benefit from the innovation. Based on the best available

evidence, reducing minor procedure pain by breastfeeding and breast milk would be

transferred to target setting successfully.

Time for implementation and evaluation

The Gantt chart for implementing the innovation is shown in Appendix 7. It

was estimated that a total of twelve months is needed to implement and evaluate the

proposed innovation. The preparation period and pilot testing will take five-months. A

working committee will be recruited, who are responsible for manpower and

resources arrangement. Colleagues can refer to them whenever they have questions.

The committee will introduce the innovation to the colleagues in the proposed setting

through short presentation and small group discussion (all around 10 minutes) before

handover between the morning and afternoon shift. Email will also sent to all nurses

working in the SCBU, so colleagues on long night shift or long leave have

information about the pilot testing. The pilot testing will launch during daytime to let

the colleagues get familiarize with the rundown of the new practice.

We will then use a month to revise the program based on the pilot testing, and

which will be followed by five months of full implementation. Finally, we will spend

a month to evaluate the whole program.

Feasibility

To determine the feasibility of applying the innovation to the target setting, we

need to consider the following factors, which are administrative support and nursing

autonomy, anticipated resistance, and staff training and resources.

Administrative support and nursing autonomy

24

Nursing autonomy is granted and the administrative level also supports the

implementation of new innovation in improving patient care in the target SCBU of a

public hospital in Hong Kong. Currently, different protocols have been set up by

nurses to enhance patient care in the proposed setting, such as central line care bundle

and sucrose administration protocol. These were well supported by the administrative

stakeholder including Chief of Service (COS), consultants, Department of Operation

(DOM), ward manger, and nurses of the department. Besides, the learning climate in

the target setting is strong. A journal club was set up by nursing consultants to teach

non-degree base registered nurses to read and analyse research papers, as well as to

set up protocols according to up-to-date evidence. In addition, the department also

subsidise the nursing colleagues to attend overseas conferences and training.

Post-conference and -training seminars are then held to let them share their experience

and what they have learnt abroad. These show that there is strong organisational

support in utilising research findings, as well as a strong organisational learning

climate in that both managerial and nursing staffs are supportive of evidence based

practices. Therefore, to a great extent, it is feasible to implement the proposed

innovation in the target setting.

Anticipated resistance

Resistance to change is one of the anticipated obstacles whenever

implementing an innovation. The existing staff function will not be seriously affected,

as blood taking by heel lance is the usual practice of the nurses in the proposed setting.

However, some staff might feel uncomfortable to perform blood taking in the

presence of the mothers of the neonates. Besides, mothers may feel uncomfortable to

see their babies suffer from pain as well. Nurses may need to spend extra time in

explaining the procedure to the mothers. In addition, some phlebitis and doctors are

25

male, and some mothers may not feel comfortable to breastfeed in front of male

(Upadhyay, et al., 2004), therefore the new procedure may only be able to apply to

female nursing staff thus increasing their workload. In addition, the routine blood

taking time for the post phototherapy babies is in the early morning at around 8am,

therefore if we implement the new innovation, we might need to rearrange the blood

taking time as mother may not be able to come early in the morning, which may delay

the discharge time and increase the length of stay of the babies and therefore the

workload of the frontline staff. Increasing workload is usually the main source of

resistance from the staff members.

To minimize the potential negative impact bring by the innovation, a pilot

study will be carried out to estimate the potential workload change of the frontline

staff. This will provide a better picture of what may change after implementing the

innovation. Furthermore, breastfeeding is proven more superior in calming baby from

pain but expressed breast milk is also recommended for pain control in minor

procedure in neonates (Blass & Shide, 1994). Therefore, breastfeeding can be used as

first line non-pharmacological analgesic and breast milk can be used as second line

non-pharmacological analgesic. Mothers can express their breast milk on admission

using electrical pumps in the breastfeeding corner in the target setting and stored in

the breast milk freezer, and can be administered to the neonates before heel lance or

venipuncture instead of waiting the mothers to come and breastfeed in the morning.

Staff training and resources

The new pain prevention protocol will require staff knowledge, skills, time,

equipment, and reorganization. Nursing staff in the target setting were well trained in

capillary blood taking. Mandatory capillary blood taking program was introduced to

all nurses in their second year of working in SCBU and they need to pass the audition

26

before performing capillary blood taking alone.

In addition, the target hospital pledged to become a baby friendly hospital in

2013. All frontline staff including nurses and health care assistants attended

mandatory breastfeeding courses, therefore they had sufficient knowledge in

supervising breastfeeding during blood taking.

Necessary equipment, such as moveable curtains to provide privacy, electronic

breast pump and different kinds of blood taking devices are readily available in the

proposed setting. Nurses in the working committee need to design a leaflet for parents

explaining the procedure. In general, the facilities and equipment that we need for

implementing the innovation are easily accessible.

Cost-Benefit Analysis of the Innovation

Potential risks and benefits

There is no side effect or risk documented on the new pain reduction measure

in the reviewed papers. However, the mothers may feel exhausted after rushing

between different health care facilities and their milk production may not be as good

as expected, which will hinder the effect of breastfeeding as suggested. Therefore, we

need to provide a relaxing and comfortable environment to them. Breast milk in

reducing minor procedure pain in neonates, patients will benefit from pain reduction

by the most natural analgesic (Codipietro, et al., 2008; Marín Gabriel, et al., 2013). By

allowing mothers to take an active role in comforting their babies, breastfeeding

during minor procedure pain can increase bonding between mothers and babies, as

well as decrease maternal anxiety (Carbajal, et al., 2003). The department can also

save money from reducing sucrose purchase.

In contrary, if we do not adopt the innovation, the neonates will continue to

receive oral sucrose as analgesia, which can be contaminated easily (Uyan, et al.,

27

2005). Besides, food other than breast milk will hinder successful breastfeeding

(Howard, et al., 2003). Adopting the innovation is compatible with the baby friendly

hospital policy, in addition, nurses also act as breastfeeding promotors by encouraging

mothers to breastfeeding at all means.

Estimated cost

The cost for implementing the protocol is minimal, $7430 per year, a detailed

table showing the operational cost is attached in Appendix 8.

For the material cost, we may need to provide sterilized empty bottles, and/or

syringes and red luer lock plugs for capping the syringes for breast milk storage, and

these are provided by the central milk kitchen and the central consumable goods

distribution system of the hospital authority respectively. The hospital authority

supply most of the resources we need. The only material cost would be printing the

leaflet introducing our procedure to the parents

For non-material costs, as the proposed protocol is just added on top of the

existing hospital policy, we do not need to spend extra time and money on staff

training.

28

Chapter 4. Evidence-Based Practice Guideline

Overview of Guideline

Guideline title

An evidence based practice of using breastfeeding in reducing pain of neonates

during minor medical procedures

Aim

The aim of this guideline is to use breastfeeding as an analgesic in reducing

minor procedure pain in neonates based on best avaliable evidence.

Objectives

The objectives of the guideline are to

1. Summerise the clinical evidence of using breastfeeding in reducing minor

procedure pain in neoantes

2. Formulate clinical practice instruction for using breastfeeding on

neonates during minor procediure based on the best avalibale evidence.

3. Standardize the use of breastfeeding in neoates undergoing minor

procedure in SCBU in the taget setting

Intended users

This guideline is intended to support nurses of all levels in SCBU who take care

of neonates undergoing minor procedures on the use of breastfeedng as a pain

preventive measure.

Target population

The target population are neonates less than one month old, without congenital

medical problems, admited to SCBU for neonatal jaudice requiring blood taking by

lancet or venipuncture and who allow oral feeding

29

Recommendations

The recommendatons outlined in this guideline is formulated based on the

critical apprasal of the finding from seven published studies. Level of evidence and

grade of recommendation were given accoding to the Scottish Intercollegiate

Guideline Network (SIGN, 2013). Summaries of level of evidence and grade of

recommendation are attached in Appendix 5 and Appendix 9 respectively.

Recommendation 1: Selection Criteria

Recommendation 1.1. Healthy neonates with gestational age 37 weeks and

birhtweight >2500g, without medical instability (Grading of recommendation

A)

Evidence. Healthy full term neonates with gestational age 37 weeks,

without medical instability (Bilgen, Ozek, Cebeci, & Ors, 2001[1+]; Carbajal, et

al. 2003[1+] ; Upadhyay, et al., 2004[1++]; Uyan, et al., 2005 [1+];

Altun-Koroglu, Ozek, Bilgen, & Cebeci, 2010[1+]; Codipietro, Ceccarelli, &

Ponzone, 2008 [1+]; Marín Gabriel, et al., 2013 [1+])

Birhtweight 2500 g (Carbajal, et al. 2003 [1+] ; Upadhyay, et al., 2004[1++];

Uyan, et al., 2005 [1+]; Altun-Koroglu, Ozek, Bilgen, & Cebeci, 2010[1+];

Codipietro, Ceccarelli, & Ponzone, 2008[1+]; Marín Gabriel, et al., 2013[1+])

Recommendation 2: Breastfeeding starting time and duration

Recommendation 2.1 Breastfeeding with continous active suction should start at

least 2 minutes before and should be maintained throughout minor painful

procedure (Grading of recommendation A)

Evidence. In study by Carbajal, et al. (2003)[1+], breastfeeding started 2

minutes before venipuncture, while in Marín Gabriel, et al.(2013)[1+] study, they

30

started breastfeeding 5 minutes before heel prick. Both of them found

breastfeeding effective in minmizing minor procedure pain in neonates.

One of the most successful criteria of using breastfeeding as an analgesic is

to observe a successful lactation, therefore in Codipietro et al. (2008)[1+] study,

they did not mention the breastfeeding starting time but to observe a continous

active suction.

Skin to skin contact provide containment to babies and touch-based

intervention reduces stress and regulates emotions in infants. Therefore

continous breastfeeding should be maintained throughout procedure. (Marín

Gabriel, et al., 2013[1+]; Carbajal, et al., 2003[1+])

Recommendation 3: Timing for breast milk administration

Recommendation 3.1 If breastfeeding is not possible, breast milk should be

administrated not less than 2 minutes brefore heel lance (Grading of

recommendation A)

Evidence. Breast milk was given 2 minutes before heel prick (Bilgen, et al.,

2001[1+]; Uyan, et al., 2005[1+]; Upadhyay, et al., 2004[1+])

Recommendation 4: Amount of breast milk to be administered

Recommendation 4.1 5ml of breast milk should be administered before minor

procedure (Grading of recommendation A)

Evidence. Two of the studies administered 2ml of expressed breast milk

and found it only marginally better than control. One study used 5ml of

expressed breast milk and found that it significantly reduced crying in babies

(Upadhyay, et al., 2004[1++]).

Recommendation 5: Breast milk administration method

31

Recommendaton 5.1 Breast milk should be administered onto the anterior part

of the tongue by syringe (Grading of recommendation A)

Evidence. As 90% of taste buds are located in the first 2 cm of the tongue,

breast milk should be administered onto the anterior part of tougue to elicit the

best stimulation. Besides, the use of syringe can ensure the correct amount of

breast milk to be administered (Bilgen, et al., 2001[1+]; Uyan, et al., 2005[1+];

Altun-Koroglu, et al., 2010[1+])

32

Chapter 5: Implementation Plan

After discussing the importance of using breastfeeding or breast milk in

preventing minor procedure pain, an implementation plan should be developed to

communicate the vision and strategy for change. The communication plan will start

with identifying the stakeholders and followed by communication strategies.

Communication Plan

Identification and involvement of stakeholders

In implementing evidence based practice, stakeholder identification is important.

This is because it allows clarification of the purpose of the proposed changed,

decreases misunderstandings related to change and facilitate implementation of

change (Schmidt & Brown, 2012). The identified stakeholders are divided into two

groups: 1. Internal, and 2. External stakeholders. The internal stakeholders including

the managerial level, they are Chief of Service (COS), consultant, Department of

Operation (DOM), ward manager, advanced practice nurses (APNs). They are

important in approving and supporting the change. Users of the innovation, such as

medical officers, house officers, nurses, and phlebotomists is another group of internal

stakeholders. The external stakeholders are clients (mothers) and their babies, who are

admitted and required for blood taking by heel lance.

Communication strategies

Communication is one of the vital steps in the change process, as unclear

communication can lead to misunderstanding and misconception, and results in

unnecessary resistance. Therefore, to gain support for the change in practice, a good

communication plan should be developed.

A working group will be formed with people sharing similar thoughts and vision

for change. They are proposer, two APNs, one lactation consultant (LC) and five

33

registered nurses in the breastfeeding group who are working in the target setting. The

group members in this group are people recognize the limitation of the existing

practice, as well as the potential benefit of using breastfeeding or breast milk as

analgesia in minor procedure pain to the target population. Literature review of the

proposed innovation would be presented to the group members by the proposer in the

group meeting. Other aspects of the change process would also be discussed, for

instance, possible resistance from colleagues, schedule of implantation, evaluation

and obstacles of launching the innovation. Through collaboration and cooperation,

vision and strategy for change would be developed.

After developing the vision and strategy for change, individual meetings with

different ad hoc groups would be held to discuss their concerns and belief toward the

proposed innovation. Information sheet and assessment form would be prepared for

individual meeting. For the meeting with the pediatricians, information leaflet that

will be given to parents stating the benefit, theory and procedure of using

breastfeeding or breast milk in minimizing minor pain for neonates would be

presented for their perusal. The budget and manpower planning would be the main

concern of DOM. Therefore, cost-benefit ratio and little expenditure for carrying out

the innovation would be stressed in the meeting with DOM. In addition, the ward

manager would concern about the patient safety and manpower arrangement for the

change, therefore the working group would reinforce ward manger that no extra

manpower will be needed and guidelines will be set up to ensure standardized practice

and training for maintaining patient safety. Meeting would also held with other APNs

and LC to emphasize their roles in advising, supervising and coaching the junior staff

during implementation of the innovation.

34

Initiating the Changes

After gaining support and approval from the administrators, the proposed

innovation would be introduced to all frontline staffs including RNs and female

phlebotomists. Information about the innovation, such as the objectives, benefit, and

the implementation guideline would be introduced through small group presentation

in every Wednesday and Sunday before morning to afternoon shift handover for a

month. Colleagues are encouraged to raise out their concerns and give suggest to the

change.

Lactation consultant and one APNs in the working group will be appointed as

program coordinator for manpower and resources allocation. They are also

responsible in giving advice and assistance to nursing staff. As mentioned in previous

chapter, all colleagues in the target setting are equipped with capillary blood taking

technique using lancet, and breastfeeding knowledge, therefore no extra skill training

is need. However, LC or APNs will provide practical reinforcement training workshop

to colleagues with less than three years of SCBU experience, as they might not feel

confident in blood taking in the presence of parent. In addition, communication skill

would also be included in the workshop so colleagues are trained for effective

communication in explaining the procedure, and in replying the enquiry from the

parents.

Information pamphlets (Start from Breastfeeding) printed by Family Health

Service (2012) will be distributed to all colleagues, so they can refer to them as quick

reference for proper breastfeeding position.

Sustaining the Change Process

The sustained support from the nursing staffs is needed to ensure the new policy

is understood and followed. Questionnaires on staff acceptability and satisfaction of

35

the new innovations will be distributed after the pilot testing. Audit will be done

monthly by the proposer, LC and APNs to monitor the quality of service provided by

nursing staff. Colleagues are encouraged to give comment to the innovation and

modification to innovation

In addition, the comments from the clients participating in the innovation are also

important, questionnaires on clients’ satisfaction (Appendix 10) would be disturbed to

them upon discharge and modification to innovation would be made according to the

feedback from clients before full implementation of the innovation. Reassurance

Pilot Testing

A pilot study last for three months would be carried out before full

implementation to test the feasibility of the innovation, staff acceptability, and

satisfaction. By carrying out the pilot study, we can also evaluate the effectiveness and

difficulties encounter during implementation of the innovation to clinical setting.

Revision to the clinical guideline would be made according to pilot study before full

implementation. The pilot study would only be carried out in the morning and

afternoon shifts, but not at nighttime as the manpower at night shift is limited and

admission for neonatal jaundice is limited. The working team will be responsible for

conducting the pilot study, such as preparing the printed material and data analysis.

The inclusion criteria for subject recruitment will be the same as the proposed

innovation so as to keep the homogeneity of population. By maintaining homogeneity

between target population, we can made accurate evaluation on the feasibility and

potential barriers in implementing the innovation. Convenience sampling would be

used to recruit a group of healthy neonates who are suspected of neonatal jaundice

and are referred from the Maternal and Child Health Center (MCHC) or the Accident

and Emergency Department (AED) for blood taking for assessing bilirubin level.

36

A quick reference folder would be prepared by the working group including the

information leaflet to parents, consent form for participating in the pilot testing,

reference for proper breastfeeding positioning, EBM storage, checklist for blood

taking by heel lance, and questionnaire to clients. The quick reference guideline

would be put in the Special Care Baby Unit (SCBU) of the target setting.

Intervention outcome, pain score, will be assessed and record in data collecting

sheet by the APNs or LC in working group to provide objective data for further

investigation and analyze for the effectiveness of the innovation. Questionnaires will

be given to mother (Appendix 10) and nursing staffs (Appendix 11) in assessing their

satisfaction towards the innovation. They are also encourage to give comments and

suggestion in the comment session of the questionnaire.

Process and outcome evaluation would be done by the working group in the

following aspects: 1. sample recruitment, 2. smoothness of the procedure, 3. pain

score of the neonates, 4. duration of crying time of neonates, 5. satisfaction of the

clients and colleagues

The sample recruitment would be assessed by the number of eligible clients

entered the pilot testing and the dropout rate from the new practice. The smoothness

of the procedure would be assessed by the number of attempt for heel lance for

adequate blood sampling. The nursing staff satisfaction towards the new innovation,

such as adequacy of training and support for the innovation, clearness of the guideline

and barriers encountered will be evaluated. For clients, satisfaction of the procedure,

such as adequacy of explanation by the nursing staff, privacy during procedure and

appropriateness of the education leaflet will include in the process evaluation.

For the outcome evaluation, the APN or LC in the working group are responsible

for recording the duration of neonates crying time, number of attempt of heel lance

37

and pain score by NIPS (Appendix 12), so as to prevent bias. We would also take

clients and nursing staff comments into account, and work out for a better final

guideline for full implementation.

38

Chapter 6 Evaluation Plan

Ongoing evaluation of an innovation through outcome measurements is

necessary to ensure successful incorporation into clinical practice (Schmidt & Brown,

2012). In the following chapters, a detailed evaluation plan was discussed in terms of

patient outcome, healthcare, as well as the system outcome. The nature and number of

patient involved was calculated. Besides, data analysis was also discussed.

Intervention Outcome and Outcome Measurements

Patient outcome

The primary outcome of the innovation is to minimize minor procedure pain in

neonates by breastfeeding or breast milk. The outcome measures for pain control will

be pain scores. All neonates will be scored according to the Neonatal Infant Pain Scale

(NIPS) (Lawrence, et al., The development of a tool to assess neonatal pain, 1993).

The NIPS is a validated pain scale in assessing the response of full term neonates

(gestational age >37 weeks to 6 weeks after delivery) to pain stimuli. The NIPS

includes six behavioral indicators, they are arms and legs movement, facial expression,

cry, breathing patterns, and state of arousal. Score ranges from 0 to 1 in each category,

with the exception to cry which ranges from 0 to 2. A total score ranges from 0 to 7,

with 0 indicates no pain and 7 indicates sever pain. NIPS score < 4 means no pain to

mild pain, and NIPS score ≥ 4 means moderate to severe pain.

The NIPS is used because there was extensive testing of NIPS in clinical settings,

which showed high interrater reliability (Pearson correlations ranged from 0.92 to

0.97 across successive minutes of observation) and internal consistency (Cronbach's

alphas were 0.95, 0.87, and 0.88 for before, during, and after the procedures,

respectively). (Lawrence, et al., 1993). Besides, construct and concurrent validity

39

were established by correlations between NIPS scores at each minute of observation

and scores on the Visual Analogue Scale (Lawrence, et al., 1993). In addition, no

additional assessment skills or equipment is required for using NIPS (Gallo, 2003).

Therefore, nurses working in the target setting (especially the assessor in the working

group) were able to assess the six behavioral indicators addressed by NIPS. The pain

score will be recorded at 2 minutes after sampling.

Healthcare provider and system outcome

As the staff skill in blood taking, communication skill on introducing the

innovation to client will affect the quality of care delivered and affect the client

satisfaction rate. Therefore, staff competency will be assessed by the program

coordinators through return demonstration and quizzes on breastfeeding position and

blood taking technique. In addition, the staff satisfaction and acceptability score will

be evaluated by distributing questionnaire.

For the system outcome, the utilization of the innovation will be determined by

the number of eligible patients and the actual number of client using breastfeeding or

breast milk as minor pain preventive measure. Adverse effect will be reported if any.

Finally, manpower cost, such as time spend on implanting the innovation, and

material cost used in the innovation will be calculated and reviewed regularly.

Nature and Number of Clients Involved

Eligibility criteria

Healthy term neonates in the SCBU of the proposed setting, who are referred

from the MCHC and AED for blood taking for bilirubin and are allowed oral feeding

are eligible for participating in the innovation.

Sample size calculation

The sample size is calculated by an online software (Lenth, 2006-9). With

40

reference to study by Marin Gabriel, et al. (2013), the power of 80% with an α of 0.05

to detect a 0.5-point diffence in the NIPS score (assuming SD=1), a sample size of 67

infants are need. With an estimated 10% drop out rate, therefore a sample size of 70

patients will be sufficient.

Data Analysis and Evaluation

Data analysis

When neonates admitted to the SCBU and meet the eligible criteria, the nurses

will invite the parents to participate in the innovation by explanation and distributing

the information leaflets. The total number of patient admitted to SCBU for neonatal

jaundice and total number of patient participate involved in the innovation will be

counted to evaluate the utilization rate of the innovation. The APNs or LC or proposer

are responsible for collecting the objective patient outcome data: pain score, and the

data will be grouped together, and evaluated and analysis by the working team.

Questionnaires will be distributed to clients receiving the innovation, as well as to the

nursing staff for collecting subjective data, such as satisfaction rate, acceptability rate.

Data evaluation

The objective of the evaluation is to determine if breastfeeding or breast milk

could minimize pain in neonates during minor procedure. It is designed to evaluate all

subjects who need heel prick and receive the innovation. Pain score of neonates will

be collected. Hypothesis testing will be used to analyzing the data. Two-tailed z-test

will be used. It could demonstrate pain score is changed since the implementation of

the innovation.

Criteria for Effectiveness

For calculating the effectiveness of the innovation in reducing pain in neonates,

patients pain score will be analyzed. In study by Marin Gabriel et al. (2013), a 20%

41

reduction of pain score was detected in the breastfeeding group when compared to the

control. Therefore, a reduction of 20% pain score in our target group is considered

effective. For the health care provide outcome, the aims is to achieve a miminal

resistance to the implementation of the new practice and full compliance of the

innovation. In regard to the organzation outcome, the innovation aims to reduce at

least 40% of resoucres when compare to the current practice.

Conclusion

As neonates cannot verbalize their distress from pain, and it is known that pain

will create both short and long-term impact in neonates, therefore we should

continuously look for ways to improve the nursing outcome in pain prevention

neonates. Data from literature review showed that breastfeeding and breast milk are

effective in minimizing minor procedure pain in neonates. Using breastfeeding or

breast milk as analgesic is safe and gives positive outcome to the neonates, parents as

well as the health care system. As baby-friendly hospital is a trend in Hong Kong,

therefore it is worthy to implement the innovation in SCBU after analyzing the cost,

benefit and risks.

An evidence-based protocol should be developed for launching the innovation

successfully to the clinical settings. Communication with the stakeholders before

implementation of the innovation is important to clear misunderstanding and to gain

support for changes. Pilot testing before full implementation is essential for problem

identification. After evaluating the effectiveness of the pilot study a thorough

evidence based guideline should be developed. In regard to the benefit and feasibility

of the innovation, in addition to the baby friend hospital policy, it is believed that the

innovation could be applied to the SCBU.

42

Appendix 1 – Summary of search terms and search results

Search terms Databases

PubMed CLINAL(EBSCOhost) Ovid MEDLINE(R) Date of search 8/2014 8/2014 9/2014

1. Inant, newborn Or neonate

59519 81606 508173

2. Pain 584271 163032 111130

3. Analgesia or Analgesic

532320 29657 48659

4. Breastfeeding or Breast feeding or Breast-feeding or Breast milk

36993 17478 34051

5. Heel lance or Heel stick or Heel prick or Venepuncture or Injection or Immunization or Vaccination

825198 8961 475866

1+2+2+4+5 1485 80 11

Limit to RCT 106 7 7

Limit to language 107 6 7

No of relevant studies 17 11 5

No. of duplicated paper 19

No of excluded paper 7

No. of selected paper 7

43

Appendix 2: PRISMA 2009 Flow Diagram of Included and Excluded Studies

Full-text articles excluded, with reasons

(n = 6)

Full-text articles assessed for eligibility

(n = 13)

Records identified through database searching

(n = 33)

Scr

een

ing

In

clu

ded

E

ligib

ilit

y

Iden

tifi

cati

on

Records screened (n = 14)

Studies included in qualitative synthesis

(n = 0 )

Records after duplicates removed (n = 14)

Records excluded (n = 1)

Studies included in quantitative synthesis

(meta-analysis) (n = 7)

44

Appedix 3: Table of evidence

Bibliographic citation

Study type

Patient characteristics Painful

procedure Intervention 1.1 Comparison Outcome measure *Effect size

Altun-Koroglu et al. (2010)

RCT Healthy full term newborn (n=75)

GA=37-41 weeks

BW=2590-4290g

Apgar score ≥ 7 at 5min

PN age=4-10 days

Heel prick 1. 1ml Hindmilk (n=25) 2. 1ml sucrose (n=25) 3. 1ml DW(n=25)

a. Crying time b. Duration of tachycardia c. Neonatal Facial Coding

System (NFCS) scores

1.2 a=84(p<0.05) 1.3 a=-79 (p=0.022) 1.2 b=10 (p<0.05) 1.3b=-160 (P=0.009) 1.2 c=0.99-0.8(p<0.001) 1.3c=1.26—1.1(p<0.001)

Bilgen H. et al. (2001)

RCT Healthy term infant (n=130)

GA=37-48 weeks

BW=2380-4300g

Apgar score ≥ 7 at 5min

PN age >24 hours

Heel Prick 1. Breast milk (n=33) 2. Breastfeeding (n=28)

3. 2ml 25% sucrose (n=35)

4. 2ml Sterile water (n=34)

a. Crying time (s) b. % change in HR- c. Infant Body Coding

System (IBCS) score

1.3 a=26 (p=0.01) 2.3 a=15(p=0.64) 1.4 a=10(p=0.36) 2.4 a=-1(p<0.08) 1.3 b=12/9/13 2.3 b=27/10/21/ 1.4 b=1/-6/-5 2.4 b=6/-5/3 1.3.c=2(p=0.001) 2.3 c=2 (p=0.001) 1.4 c=-0.5 (p=0.24) 2.4 c=-0.5(p=0.4)

Carbajal R. et al. (2003)

RCT Newborn infant (n=180)

GA ≥ 37 weeks

Mean BW=3304-3420g

Apgar ≥ 7 at 5 min

PN age ≥ 24 pours

Excluded drug exposure

Venepuncture 1. Breastfeeding (n=44) 2. Held in mother arms (n=45)

3. Laid on tale with 1ml SW w/o pacifier (n=45)

4. 1ml 30% glucose w/ pacifier (n=45)

Primary outcome a. Douleur aigue du

nouveau-ne scale (DAN) Secondary outcome

b. Premature Infant Pain Profile (PIPP)

1.2 a=-7(p<0.0001) 1.2 b=-8(p<0.0001) 1.3 a=-7(p<0.0001) 1.3 b=-7(p<0.0001) 1.4 a=0(p=0.16) 1.4 b=-1 (p=0.28)

45

Codipietro et al. (2008)

RCT Term neonate (n=101)

GA= 37-42 weeks

Mean BW=3307-3318g

Apgar score ≥ 7 at 5min

PN age ≥60 hours

Excluded birth in anaesthesia

Heel lance 1. Breastfeeding (n=51)

2. 1ml 25% sucrose (n=50)

a. Premature Infant Pain Profile (PIPP) score

b. Change in HR c. % of cry ain 2 min

1.2 a=-5 (p=0.0001) 1.2 b=-9 (p=0.005) 1.2 c=-10 (p=0.0004)

Marin Gabriel et al. (2013)

RCT Healthy term neonates (n=136)

GA= 37-41 weeks

Median BW=3215-3359g

Apgar score ≥ 7 at 5min

PN age>24hours

Excluded birth under GA

Heel lance 1. BF + SSC (n=35)

2. Sucrose + SSC (n=35) 3. SSC (n=33) 4. Sucrose (n=33)

a. Neonatal Infant Pain Scale (NIPS) score^

b. Crying time c. HR^^ d. % of crying time

1.2 a= -1/-1/0(p=0.002) 1.2 b=-3 (p=0.01) 1.2 c=-17/-11/-11 (p=0.007) 1.2d=-2 1.3 a=0/-3/-1(p<0.01) 1.3 b=-24 (p=0.01) 1.3 c=-17/-11/-11 1.3 d=-49 (p=0.02) 1.4 a=-1/-3/-1(p=0.004) 1.4 b=-11 (p=0.01) 1.4 c=-19/-6/-6 (p=0.001) 1.4 d=-20

Upadhyay A. et al.(2004)

ECT Full-term (n=87)

GA=37–41weeks

Mean BW= 2.8-2.9±0.3kg

Apgar score ≥ 7 at 1 min

PN age 1-4weeks

Excluded birth in anaesthesia

Venepuncture 5ml EBM (n=40) 5ml sterile water (n=41)

Primary outcome: 1. duration of crying (s)

Secondary outcome: 2. change in HR + 3. Modified NSCF+

1. -70.7 (p<0.01) 2. -9/-12/-16 (p<0.01) 3. -0.8 ±1.3 (p<0.01)

-1.8 (p<0.01) -2 ±0.6 (p<0.05)

46

Remarks:

HR= Heart rate S=second GA= gestational age PN=postnatal BF= Breastfeeding SSC=Skin-to-skin contact BW=Birth weight

EMB=expressed breast milk DW= distilled water

* Effect size= Intervention – control

-percentage change in heart rate after heel prick at 1, 2 and 3 minute

+NFCS and change in heart rate (beat per min) effect size at 0, 1 and 3minute

# Pain score effect size at 0, 1, 2 and 3minute

^ NIPS score effect size at between 110-12s before sampling/ between 0-10s after heel lance/ between 120-130s after sampling

^^ Heart rate effect size at between 110-12s before sampling/ between 0-10s after heel lance/ between 120-130s after sampling

Uyan Z. S. et al.(2005)

Quasi-RCT Healthy term infants (n=62)

GA ≥ 37weeks

BW =2800-4500g

Apgar score > 7 at 5 min

PN age >48hours

Heel prick 1. 2ml Foremilk (n=20) 2. 2ml Hindmilk (n=21)

3. 2ml Sterile water (n=21)

a. Median crying time b. Duration of first cry c. % change in HR d. Neonatal Facial Coding

System (NFCS)#

1.3 a=9 (p=0.19) 1.3 b=19.(p=0.08) 1.3 c=0.2 (p=0.22) 1.3

d=-0.75/1/-0.5/-0.5(p=0

.58/0.55/.58/0.84) 2.3 a=-8 (p=0.19) 2.3 b=-11 (p=0.08) 2.3 c=-8.6 (p=0.22) 2.3 d=-1/0/-0.5/-1 (p=0.58/0.55/.58/0.84)

47

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Altun-Koroglu, O., Ozek, E., Bilgen, H., & Cebeci, D. (2010). Hindmilk for procedural pain in neonates. The Turkish Journal of Pediatrics, 52, 623-629..

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes ✓ Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes ✓ Can’t say

No

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

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?

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).

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.

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? Code as follows:

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.

As concluded by the authors, although 12.5% sucrose was slightly better than hindmink as analgesic, they still suggested using breast milk as analgesic. In addition, they maximized the analgesic effect by hindmilk by using repeated dose. The overall design is good and the study addressed my research question.

48

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Bilgen, H., Ozek, E., Cebeci, D., & Ors, R. (2001). Comparison of sucrose, expressed breast milk, and breast-feeding on the neonatal response to heel prck. American Pain Society, 2(5), 301-305.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say ✓

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

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).

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.

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? Code as follows:

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.

To summarise, sucrose was superior to breastfeeding or breast milk in reducing pain in neonates. The slightly difference in the outcome measures between breastfeeding and breast milk group also suggested that suckling the breast did not give extra effect in pain control. However, breastfeeding was stopped just before procedure main also hider the effect of breastfeeding in pain control. In breastfeeding study, it is difficult to blind the participants and investigator. However, in this study, the outcome assessors were blind to the intervention groups, to a certain extent, this may help to minimize bias in outcome analyze.

49

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Carbajal, R., Paupe, A., Hoenn, E., Lenclen, R., & OlivierMartin, M. (1977). DAN: evaluation behavioral scale of acute pain in newborn infants. Archives Pediatrie, 4, 623-628.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say ✓

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

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).

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.

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? Code as follows:

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.

Breastfeeding was an effective analgesia. However there were limitations of the study. Although the observers were masked to the purpose and hypotheses of the study, they still recognize the intervention groups. The authors used PIPP in concurrent with the DAN scale to raise the validity of the results. Due to the nature of study, it was not possible to blind the participants and observers, even the observers were blind to the purpose and hypothesis of the study, personal bias may exist.

50

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Codipietro, L., Ceccarelli, M., & Ponzone, A. (2008). Breastfeeding or oral sucrose solution in term neonates recieveing heel lance: a randomized, controlled trial. American Academy of Pediatrics, 122, e716-e721.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say ✓

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

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).

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.

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? Code as follows:

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.

As concluded by the authors, the PIPP score in breastfeeding group was lower than those in sucrose group, and the physiological data was lower than participants in sucrose group. The participants were randomized into different group by computer random number generator. Allocation was done by the sample performer who opened the opaque, sealed envelopes sequentially. As the nature of study intervention, masking to participants and investigators were not possible, therefore bias may exist. However, the author used objective data in conjunction with pain scale which increased the validity of the study.

51

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Marín Gabriel, M. Á., del Rey Hurtado de Mendoza, B., Jiménez Figueroa, L., Medina, V., Iglesias Fernández, B., Vázquez Rodríguez, M., et al. (2013). Analgesia with breastfeeding in addition to skin-to skin contact during heel prick. Arch Dis Child Fetal Neonatal Ed, 98, 499-503.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes Can’t say

No ✓

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

5.88%

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

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.

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? Code as follows:

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.

As summarize by the authors, breastfeeding in addition to skin to skin contact was superior than other non-pharmacological interventions. In this study, randomization was done by closed, opaque envelopes. Parents and nurses were masked to the randomization group but not to the treatment. Same as other breastfeeding study, masking to participants and investigator were impossible. They try to increase the reliability of the outcome measures by including three observers to the study. Although the CCI was >0.6 between observers, but only data from one observer was being used for investigation.

52

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Upadhyay, A., Aggarwal, R., Narayan, S., Joshi, M., Paul, V. K., & Deorari, A. K. (2004). Analgesic efect of ecpressed breast milk in procedural pain in term neonates: a randomized, placebo, double-blind trial. Acta Paediatr, 93, 518-522.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes ✓ Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say ✓

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

6.90%

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

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.

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? Code as follows:

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.

As concluded by the authors, give 5ml EBM to neonates was effective before blood sampling by venepuncture when compared to placebo. To minimize the difference between groups, babies who cried before procedure were excluded. The randomization was done by using computer generated numbers. Although breastfeeding is the observers were masked to the intervention giving to participants.

53

Appendix 4: SIGN Methodology Checklist 2

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages) Uyan, Z. E., Ozen, E., Bilgen, H., Cebeci, D., & Akman, I. (2005). Effect of foremilk and hindmilk on simple procedural pain in newborns. Pediatrics international, 47, 252-257.

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.

Yes ✓ Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes ✓ Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say ✓

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say ✓

No

1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes ✓ Can’t say

No

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

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).

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.

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? Code as follows:

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.

As summarized by the authors, the outcome measures did not reach a statistical significant even hindmilk was shown to have superior effect than foremilk in providing analgesic effect. This is a quasi-randomization controlled trial. However, it was not known that the investigators were masked to the study. The investigators were unaware of the intervention allocation.

54

Appendix 5: Table of Quality Assessment Table of Selected RCTs (Internal Validity)

Studies Altun-Koroglu et

al. (2010) Bilgen H. et al.

(2001) Carbajal R. et al.

(2003) Codipietro L. et

al.(2008)

Marin Gabriel M. A. et al.

(2013)

Upadhyay A. et al. (2004)

Uyan Z. S. et al. (2005)

Clearly focused question

+++ +++ +++ +++ +++ +++ +++

Raondomization ++ + ++ +++ ++ +++ +

Adequate concealment

++ ++ + ++ + +++ ++

Blindness to treatment

- + + + + ++ -

Simlarity between groups at start

++ +++ +++ +++ +++ +++ +++

Only difference is treatment

+++ +++ +++ +++ +++ +++ +++

Reliable and valid outcome measures

+++ ++ ++ ++ +++ +++ ++

Dropout rate 0% 0% 0% 0% 5.88% 5.9% 0%

Intention to treat analysis

NR NR NR ++ ++ NR NR

Result comparibilty between sites

NA NA NA NA NA NA NA

Level of evidence 1+ 1+ 1+ 1+ 1+ 1++ 1+

* Well covered (+++) Adequately addressed (++) Poorly addressed (+) Not addressed (-) Not reported (NR) Not applicable (NA) * Coding system: Good quality=1++ Fair quality =1+ Poor quality=1-

55

Appendix 6: SIGN Grading System-Levels of Evidence

SIGN GRADING SYSTEM 1999 – 2012

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

GRADES OF RECOMMENDATIONS

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

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+

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++

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good practice points

Recommended best practice based on the clinical experience of the guideline development group

A

B

✓

D

C

56

Appendix 7: Schedule for implementing the evidence-based

Tasks

Months

1 2 3 4 5 6 7 8 9 10 11 12

Recruit working

committee

Resources arrangement

Briefing sessions

Carrying out pilot testing

in day time

Revision of pilot testing

Full implementation

Evaluation

57

Appendix 8: Operational cost of implementing breastfeeding as pain relieving measure

Set up cost

I. Preparation

Staff Description Cost (HKD)

1 Nursing Consultant

Work for 5 hours

Prepare materials

and organize

seminars

HKD 363x5hrs=HKD1815

1 Advanced Practice Nurse (APN) HKD 280x5hrs=HKD1400

1 Lactation Consultant (LC) HKD 181x5hrs=HKD905

2 Registered Nurses (RN) HKD 181x5hrs=HKD1810

Total: HKD 5930

II. Training

Blood taking technique Mandatory training according to

hospital policy N/A

Breastfeeding knowledge

Total: HKD 0

III. Material Cost

Venue for briefing sessions

N/A A/V in target setting Computers and computer software

Stationary

Total: HKD 0

Running Cost

Material Cost

Venue for *BF + blood taking

N/A A/V in target setting

Movable curtain

Tourniquets

Alcohol swab for skin disinfection

Lancet/Angiocath/Scalp Vein

Infusion Set

Band aids

Electrical milk pump

Sterilized milk bottle

10ml syringes

Luer lock plug

Freezer for breast milk storage

Introductory pamphlets to parents HKD 1.5/set (1000 sets per year) HKD 1500

Total: HKD 1500

Overall estimated cost of the program: HKD 7430

Remark: *BF= Breastfeeding

58

Appendix 9: Summary of grade of recommendations An evidence based practice of using breastfeeding in reducing pain of neonates

during minor medical procedures

Intended users: Nurses working in SCBU

Target population: Neonates aged less than 1 month old, with body weight >2500g

and medically stable

Recommendation Grading of

recommendation

Eligible criteria Medically stable term neonates

with birth weight not less than

2500 g are eligible

A

Breastfeeding starting time

and duration

Breastfeeding with continous

active suction (large amount of

areola in the mouth, flanged lips,

and active jaw movements)

should start at least 2 minutes

before and should be maintained

throughout minor painful

procedure.

A

If breastfeeding is not possible, *EBM should be used as alternative

Timing for breast milk

administration

Breast milk should be

administrated no less than 2

minutes before minor painful

procedure.

A

Amount of breast milk to

be administered

5ml of breast milk should be

administered before minor painful

procedure.

A

Breast milk administration

method

Breast milk should be

administered by syringe onto the

anterior part of the tongue

A

Remark: *EBM= expressed breast milk

59

Appendix 10: Questionnaire to Parents

Patient Gum Label

60

Appendix 11: Questionnaire to Nursing Staff

61

Appendix 12: Data Assessment Form:

Data Assessment Form

Date of Assessment: ____________________

Time suckling: _________________________minutes

*Blood taking start at 2 minutes after suckling

A. Pain Assessment

Neonatal Infant Pain Scale (NIPS)

PARAMETER FINDING POINTS

Facial expression Relaxed 0

Grimace 1

Cry No cry 0

Whimper 1

Vigorous crying 2

Breathing Patterns Relaxed 0

Change in breathing 1

Arms Restrained 0

Relaxed 0

Flexed 1

Extended 1

Legs Retrained 0

Relaxed 0

Flexed 1

Extended 1

State of arousal Sleeping 0

Awake 0

Fussy 1

Total Score /7

No. of heel lance attempted for adequate blood sample: ________________

Name of Assessor: ____________________________ Signature of Assessor: ____________________________

Patient Gum Label

An Evidence Based Guideline of Using Breastfeeding in Reducing Pain of Neonates During Minor Medical Procedure

62

References

AAP. (2000). Prevention and management of pain and stress in the neonate. Pediatrics,

105, 454-461.

Altun-Koroglu, O., Ozek, E., Bilgen, H., & Cebeci, D. (2010). Hindmilk for

procedural pain in neonates. The Turkish Journal of Pediatrics, 52, 623-629.

Anand, K. J. (2000). Pain,plasticity, and premature birth: a prescription for permanent

suffering? Nature medicine, 6(9), 971-973.

Association, B. F. (2013, August). WBW annual survey summary. Retrieved Sept 1,

2014, from

http://www.babyfriendly.org.hk/wp-content/uploads/2013/07/2013-WBW-Rep

ort-E-final-as-of-July-24.pdf

Ballantyne, M., Stevens, B., McAllister, M., Dionne, K., & Jack, A. (1999). Validation

of the premature infant pain profile in the clinical setting. Clinical Journal of

Pain, 15(4), 297-303.

Bilgen, H., Ozek, E., Cebeci, D., & Ors, R. (2001). Comparison of sucrose, expressed

breast milk, and breast-feeding on the neonatal response to heel prick.

American Pain Society, 2(5), 301-305.

Blass, E. M., & Shide, D. J. (1994). Some comparisons among the calming and pain

relieving effects of sucrose, glucose, fractose and lactose in infant rats.

Chemical Senses, 19, 239-49.

Blass, E. M., Shide, D. J., Zaw-Mon, C., & Sorrentino, J. (1995). Mother as shield:

differential effects of contact and nursing on pain responsivity in infant

rats-evidence for nonopioid mediation. Behavioral Neuroscience, 109,

342-353.

Carbajal, R., Paupe, A., Hoenn, E., Lenclen, R., & OlivierMartin, M. (1977). DAN:

63

evaluation behavioral scale of acute pain in newborn infants. Archives

Pediatrie, 4, 623-628.

Carbajal, R., Veerapen, S., Couderc, S., Jugie, M., & Ville, Y. (2003). Analgesic effect

of breast feeding in term neonates: randomized controlled trial. British

Medical Journal, 326(7379), 13-15.

Codipietro, L., Ceccarelli, M., & Ponzone, A. (2008). Breastfeeding or oral sucrose

solution in term neonates recieveing heel lance: a randomized, controlled trial.

American Academy of Pediatrics, 122, e716-e721.

Craig, K. D. (1992). The facial expression of pain. Better than a thousand words?

American Pain Society, 1, 153-162.

Craig, K. D., Whithfield, M. F., Grunau, R. V., Linton, J., & Hadijstavropoulous, H. D.

(1993). Pain in the preterm neonate: behavioural and physiological indices.

Pain, 52, 287-299.

Dilli, D., Kucuk, I. G., & Dallar, Y. (2009). Interventions to reduce pain during

vaccination in infancy. The Pediatrics, 3, 385-390.

Gallo, A. M. (2003). The fifth vital signs: implementation of the neonatal infant pain

scale. Jognn, 32(2), 199-206.

Goswami, G., Upadhyay, A., Gupta, N. K., Chaudhry, R., Chawla, D., & Sreenivas, V.

(2013). Comparison of analgesic effet of direct breastfeeding oral 25%

dextrose solution and placebo during 1st DPT vaccination in healthy term

infants: a randomized, placebo controlled trial. Indian Pediatrics, 50, 649-653.

Gray, L., Miller, L. W., Pillipp, B. L., & Blass, E. M. (2002). Breastfeeding is

analgesic in healthy newborns. Pediatrics, 109, 590-593.

Grunau, R. E., Holsti, L., & Peters, J. W. (2006). Long-term consequences of pain in

human neonates. Semin Fetal Neonatal Medicine, 11, 268-275.

64

Grunau, R. V., & Craig, K. D. (1990). Facial activity as a measure of neonatal pain

expression. In D. C. Tyler, & E. J. Krane, Advances in pain reseach and

therapy (pp. 147-155). New York: Raven Press.

Gunnar, M. (1984). The effects of a pacifying stimulus on behavioral and

adrenocortical responses to circumcision in the newborn. Journal of the

American Academy of Child and Adolescent Psychiatry, 23, 34-38.

Holsti, L., & Grunau, R. E. (2010). Considerations for using sucrose to reduce

procedural pain in preterm infants. Pediatrics, 125(5), 1042-1047.

Holsti, L., Grunau, R. E., Oberlander, T. F., & Whitfield, M. F. (2004). Specific

NIDCAP movements help identify acute pain in preterm infants in the NICU.

Pediatrics, 114, 65-72.

Howard, C. R., Howard, F. M., Lanphear, B., Eberly, S., deBlieck, E. A., D., O., &

Lawence, R. A. (2003). Randomized clinical trial of pacifier use and bottle

feeding or cup feeding and their effect on breastfeeding. Pediatrics, 111,

511-518.

Lawrence, J., Alcock, D., & McGrath, P. (1993). The development of a tool to assess

neonatal pain. Neonatal Network, 12, 59-66.

Lawrence, J., Alcock, D., McGrath, P., Kay, J., MacMurray, B., & Dulberg, C. (1993).

The development of a tool to assess neonatal pain. Neonatal Network, 12,

59-66.

Lawrence, J., Alcock, D., McGrath, P., Kay, J., MacMurray, S. B., & Dulberg, C.

(1993). The development of a tool to assess neonatal pain. Neonatal Network,

12(6), 59-66.

Lenth, R. V. (2006-9). Java Applets for Power and Sample Size(computer software).

Retrieved from http://homepage.cs.uiowa.edu/~rlenth/Power/

65

Lundington-Hoe, S. M., & Swinth, J. (1996). Developmental aspects of kangaroo care.

JOGN, 25, 671-70.

Marín Gabriel, M. Á., del Rey Hurtado de Mendoza, B., Jiménez Figueroa, L.,

Medina, V., Iglesias Fernández, B., Vázquez Rodríguez, M., Medina Malagón,

L. (2013). Analgesia with breastfeeding in addition to skin-to skin contact

during heel prick. Archives of Disease in Childhood-Fetal and Neonatal

Edition, 98, 499-503.

Modarres, M., Jazayeri, A., Rahnama, P., & Montazeri, A. (2013). Breastfeeding and

pain relief in full-term neonates during immunization injections: a clinical

randomized trial. BMC Anesthesiology, 13(22). Retrieved from

http://www.biomedcentral.com/1471-2253/13/22

Okan, F., Ozdil, A., Bulbul, A., Yapici, Z., & Nuhoglu, A. (2010). Analgesic effects of

skin-to-skin contact and breastfeeding in procedural pain in healthy term

neonates. Annals of Tropical Paediatrics, 30(2), 119-128.

Ors, R., Baysoy, G., Cebeci, D., Bilgen, H., Turkuner, M., & Basaran, M. (1999).

Comparison of sucrose and human milk on pain response in newborns.

European Journal of. Pediatrics, 158, 63-66.

Owens, M. E., & Todt, E. H. (1984). Pain in infancy:neonatal reaction to heel lance.

Pain, 20, 77-86.

Ozdogan, T., Akman, I., Cebeci, D., Bilgen, H., & Ozek, E. (2010). Comparison of

two doses of breast milk and sucrose during neonatal heel prick. Pediatrics

International, 52.

Phillips, R. M., Chantry, C. J., & Gallagher, M. P. (2005). Analgesic effects of

breast-feeding or pacifier use with maternal holding in term infants.

Ambulatory Pediatrics, 2005(5), 359-364.

66

Ramenghi, L. A., Wood, C. M., Griffith, G. C., & Levene, M. I. (1996). Reduction of

pain response in premature infants using intraoral sucrose. Archives of Disease

in Childhood-Fetal and Neonatal Edition, 74(2), F126-128.

Rao, M., Blass, E. M., Brignol, M. M., Marino, L., & Glass, L. (1997). Reduced heat

loss following sucrose ingestion in premature and normal human newborns.

Early human development, 48, 109-116.

Reis, E. C., Roth, E. K., Syphan, J. L., Tarbell, S. E., & Holubkov, R. (2003).

Effective pain reduction for multiple immunization injections in young infants.

Archives of Pediatrics and Adolescent Medicine, 157, 1115-1120.

Schmidt, N. A., & Brown, J. M. (2012). Evidence-based practice for nurses:

appraisal and application of research. Sudbury: Jones & Bartlett Learning.

Shah, V. & Ohlsson, A. A. (2004). Pain in the newborn. In R. L. Davis, V. A. Moyer,

& E. J. Elliott, Evidence based pediatrics and child health (pp. 509-522).

London: BMJ Books.

Simons, S. H., van Dijk, M., Anand, K. S., Roofthooft, D., van Lingen, R. A., &

Tibboel, D. (2003). Do we still hurt newborn babies?: A prospective study of

procedural pain and analgesia in neonates. Archives of Pediatrics and

Adolescent Medicine, 157(11), 1058-1064.

Skogsdal, Y., Eriksson, M., & Schollin, J. (1997). Analgesia in newborns given oral

glucose. Acta Paediatric, 86, 217-220.

Slater, R., Cantarella, A., Gallella, S., Worley, A., Boyd, S., Meek, J., & Fitzgerald, M.

(2006). Cortical pain responses in human infants. The Journal of Neuroscience,

26(14), 3662-3666.

Unicef. (2014, Sept 1). About the Hong Kong association. Retrieved from UNICEF

baby friendly hospital initative Hong Kong association:

67

http://www.babyfriendly.org.hk/en/about-us/about-the-hong-kong-association/

Unicef. (2014, Sept 1). Healthcare facilities. Retrieved from UNICEF baby friendly

hospital initiative Hong Kong association:

http://www.babyfriendly.org.hk/en/to-become-baby-friendly/healthcare-faciliti

es/

Upadhyay, A., Aggarwal, R., Narayan, S., Joshi, M., Paul, V. K., & Deorari, A. K.

(2004). Analgesic efect of ecpressed breast milk in procedural pain in term

neonates: a randomized, placebo, double-blind trial. Acta Paediatr, 93,

518-522.

Uyan, Z. E., Ozen, E., Bilgen, H., Cebeci, D., & Akman, I. (2005). Effect of foremilk

and hindmilk on simple procedural pain in newborns. Pediatrics international,

47, 252-257.

Valentine, C. J., Hurst, N. M., & Wertheim, L. (1994). Hindmilk improves weight gain

in low-birth-weight infants fed human milk. Journal of Pediatric

Gastroenterology and Nutrition., 18, 474-477.

Weissman, A., Aranovitch, M., Blazer, S., & Zimmer, E. Z. (2009). Heel lancing in

newborns: behavioral and spectral analysis assessment of pain control

measures. Pediatrics, 124(e), 921-926.

Weller, A., & Feldman, R. (2003). Emotion regulation and touch in infants: the role of

cholecystokinin and opioids. Peptides, 24, 779-788.

Williams, A., & Manias, E. (2008). A structured literature review of pain assessment

and managment of patients with chronic kidney disease. Journal of clinical

nursing, 17(1), 69-81.