A QUASI EXPERIMENT STUDY TO ASSESS THE EFFECT OF

SWADDLING ON MANAGEMENT OF THE PAIN DURING

HEEL PRICK AMONG NEONATES ADMITTED IN
NEONATAL INTENSIVE CARE UNITS AT SELECTED
HOSPITALS DIST FAZILKA, PUNJAB.

Asynopsis

submitted for the partial fulfillment of the requirement for the degree of

MASTER OF SCIENCE IN NURSING

(Child Health Nursing)

of
Baba Farid University of Health
Sciences,Faridkot,Punjab

2023

Ms. Monika Rani

Meera Medical Institute of Nursing & Hospital, Abohar

A QUASI EXPERIMENT AL STUDY TO ASSESS THE EFFECT
OF SWADDLING ON MANAGEMENT OF PAIN DURING HEEL
PRICK AMONG NEONATAL ADMITTED IN NEONATAL
INTENSIVE CARE UNITS AT SELECTED HOSPITAL DIST.
FAZILKA PUNJAB

Asynopsis

submitted for the partial fulfillment of the requirement for the degree of

MASTER OF SCIENCE IN NURSING

(Child Health Nursing)
of
Baba Farid University of Health
Sciences,Faridkot,Punjab

2023

Ms. Monika Rani

Name and Signature of Guide Name and Signature of Co-Guide

Dr. Ramswaroop Sharma Mr. Sandeep Parihar

M.Sc. (N) Child Health Nursing M.Sc. (N) Child Health Nursing
Principal-cum-Professor Associate professor
Meera Medical Institute of Nursing Meera Medical Institute of Nursing
& Hospital, Abohar & Hospital, Abohar
 ABSTRACT PLAN OF THESIS
Title A Quasi experimental study to assess the effect of
swaddling on management of pain during heel prick among
neonates admitted in neonatal intensive care units at
selected hospitals Dist Fazilka Punjab.
For the degree Master of Science in Nursing (Child Health Nursing)
Name of Candidate Ms. Monika Rani
Guide Dr. Ramswaroop Sharma
Principal cum proffessor, Ph.D in Nursing
M.Sc. (N) Child Health Nursing
Meera Medical Institute of nursing and hospital, Abohar
Co-guide Mr. Sandeep Parihar
Associate Professor
M.Sc. (N) Child Health Nursing
Meera Medical Institute of nursing and hospital, Abohar
Abohar
Institute Meera Medical Institute of nursing and hospital, Abohar
Fazilka Road
Abohar (Punjab)
University Baba Farid University of Health Sciences, Faridkot, Punajb
A quasi-experimental design with quantitative approach will be used to assess the effect of
swaddling on management of pain during heel prick among neonates admitted in neonatal
intensive care units at selected hospitals, Punjab. Approximately 60 subjects will be taken using
purposive sampling technique. Data will be collected through observation methods using
information data sheet and neonatal pain scale (NIPS).descriptive and inferential statistics will be
used for data analysis. Discussion will be based on the statistical analysis, current trends and
previous related research studies
 Synopsis
Title A Quasi experimental study to assess the effect of
swaddling on management of pain during heel prick among
neonates admitted in neonatal intensive care units at
selected hospitals, Dist. Fazilka Punjab.
Guide Dr. Ramswaroop Sharma
Principal-cum-Professor
M.Sc. (N) Child Health Nursing
Meera Medical Institute of nursing and hospital, Abohar
Co-guide Mr. Sandeep Parihar
Associate Professor
M.Sc. (N) Child Health Nursing
Meera Medical Institute of nursing and hospital, Abohar

Institute Meera Medical Institute of nursing and hospital, Abohar

Fazilka Road
Abohar (Punjab)
Submitted by Ms. Monika Rani
University Baba Farid University of Health Sciences, Faridkot, Punajb
 APPROVAL PROFORMA BY RESEARCH AND ETHICAL COMMITTEE
MEERA COLLEGE OF NURSING, ABOHAR (PUNJAB)

NAME OF THE CANDIDATE Ms. Monika Rani

TOPICS FOR THESIS A Quasi experimental study to assess the
effect of swaddling on management of
pain during heel prick among neonates
admitted in neonatal intensive care units
at selected hospitals, Dist. Fazilka Punjab.
DATE OF ENROLLTMENT
NAME OF THE GUIDE Dr. Ramswaroop Sharma
Principal-cum-Professor
NAME OF THE CO-GUIDE Mr. Sandeep Parihar
Associate Professor
Signature of Member of Research Signature of Member of Ethical
Committee Committee
Mr. Rahish Chand Dr. Ramswaroop Sharma
Vice Principal Principal-Cum-Proffessor
Chairperson Chairperson
Mrs. Jagminder Kaur Dr. Jyoti Arora
Assistant Proffessor Proffessor
Member Member
Ms. Manpreet Kaur Ms. Manpreet Kaur
Associate Professor Associate Proffessor
Member Member
Mr. Pushpinder Singh Mr. Pushpinder Singh
Assistant Proffessor Assistant proffessor
Member Member
Mr. Vikas Mahala Mr. Vikas Mahala
Assistant Proffessor Assistant Professor
Member Member
MS. Navdeep Kaur Ms. Navdeep Kaur
Assistant Proffessor Assistant Proffessor
Member Member

Approval Yes/No Approval Yes/No

Dr. Ramswaroop Sharma Dr. Ramswaroop Sharma

Principal Principal
Meera Medical Institute of nursing and Meera Medical Institute of nursing and
hospital, Abohar hospital, Abohar

Chairperson Chairperson
Research Committee Research Committee
S.No. CONTENT PAGE
NO.

1. Chapter I:
1.1 Introduction 1-2
1.2 Need of Study 2-4
1.3 Research Problem 4
1.4 Objectives 4
1.5 Operational Definations 4-5
1.6 Hypothesis 5
Delimitations 5

2. Chapter II: Review of Literature 6-8

3. Chapter III: Methodology 8

3.1 Research Approach 8
3.2 Research Design 8
3.3 Research Setting 8
3.4 Population 9
3.5 Accessible Population 9
3.6 Sampling Technique 9
3.7 Sample Size 9
3.8 Sampling Criteria 9-10
3.9 Selection and development of tools: 10
3.10 Description of tool 10
3.11 Validity of Tool 10
3.12 Pilot Study 10
3.13 Content Validity 10
3.14 Reliability of Tool 10
3.15 Ethical Consideration 10
3.16 Data Collection Procedure 11
3.17 Data Processing 11
3.18 Plan of Data Analysis 11
3.19 Discussion 11
3.20 Schematic representation of Research Methodology 12

4. References 13-14
 INTRODUCTION
The management of pain in neonates is a critical component of neonatal intensive care. Neonates are
vulnerable to pain due to their immature nervous system and their limited ability to communicate
discomfort. Prolonged exposure to pain can lead to negative consequences, including altered pain
sensitivity, developmental delays, and increased stress levels. Therefore, the proper management of pain
in neonates is essential. Heel prick is a common procedure performed in neonatal intensive care units, and
it is known to cause pain and distress to neonates.
Newborns go through pain that is comparable to that of older children and become more sensitive to
painful stimuli with repeated exposure. There are two primary ways of identifying pain: physiological and
behavioral indicators. Physiological indicators include variations in heart rate and breathing rate. Pain is a
physiological mechanism that defends the individual against harmful stimuli and signals the occurrence of
tissue damage. Behavioral indicators include crying and alterations in facial expressions.1
There are several non-pharmacological methods available to alleviate pain in neonates during minor
medical procedures. Some studies suggest that non-pharmacological interventions are the most effective
means of managing pain, including providing a pacifier containing sucrose to the infant two minutes prior
to the procedure, as this has been shown to have analgesic effects. Additionally, techniques such as
swaddling, containment or facilitated tucking, and skin-to-skin contact with the mother have also been
found to be effective. Swaddling provides stimulation across the proprioceptive, thermal, and tactile
sensory systems, which may reduce pain through the gate control mechanism.2
Swaddling, combined with upright positioning, offers nurses a non-pharmacological technique for
reducing neonatal pain during routine heel prick procedures. Swaddling positions are specifically
designed to reduce stress in the neonatal intensive care unit (NICU) and support infant development by
reducing unnecessary movements and energy expenditure. This technique can be easily implemented on
any unit without the need for specific protocols or policies, which makes it more feasible for nurses to use
in practice. Swaddling is a quick and simple non-pharmacological approach that helps to keep neonates
relaxed and minimize pain during heel prick procedures. Therefore, swaddling is one of the methods that
can be used to effectively reduce heel prick pain in neonates.3
The Canadian Paediatric Society and the American Academy of Paediatrics both recommend that
neonatal intensive care units (NICUs) have a structured pain management program in place for infants.
There are various effective methods available for managing pain, including both pharmacological and
non-pharmacological techniques, which can be used individually or in combination.4
NEED OF THE STUDY
Pain is an unpleasant sensation and emotional experience that can occur following actual or potential
tissue damage. It is typically triggered by a harmful stimulus, and its main function is to protect and
defend the body. It is now widely accepted that the neural pathways that are responsible for pain
perception are formed during the embryonic period, and they are anatomically and functionally developed
to effectively transmit painful stimuli.
Pain is a significant issue among sick newborn infants, particularly those who require intensive care.
Although pharmacological pain relief is the most commonly used approach, it may not always be
effective and can have undesirable side effects, including potential long-term neurodevelopmental
consequences. The efficacy and safety of alternative methods of pain relief for neonates are still uncertain
and require further investigation.5
There is ample evidence to support the efficacy of non-pharmacological interventions such as non-
nutritive sucking (NNS), swaddling, and facilitated tucking (FT) in reducing pain-related behaviors in
both preterm and term neonates . Kangaroo mother care (KMC) has also been found to be effective in
reducing pain, as measured by composite pain scores that include both physiological and behavioral
indicators. It is considered safe for single painful procedures and can be used alone or in combination
with other non-pharmacological interventions . Small volumes of 24% sucrose, with or without NNS,
have also been found to significantly reduce behavioral expressions of pain and crying time, as well as
scores on the Premature Infant Pain Profile (PIPP). Furthermore, if available, expressed human milk or
breastfeeding should be used to alleviate procedural pain , and 20-30% glucose has also been found to be
effective.6,7

In the neonatal intensive care unit (NICU), infants often undergo multiple painful procedures, such as
heel prick and tracheal suctioning, and are exposed to repeated painful stimuli. These experiences can
have significant and long-lasting effects on their neurological and behavioral development. Therefore,
preventing and managing pain in neonates should be a priority for all healthcare professionals, and family
members should receive education on this topic. Non-pharmacological methods have been found to be
effective in reducing pain scores during mild to moderate painful procedures in neonates, particularly for
procedural pain management. Importantly, these methods have no adverse effects or other negative
outcomes in this population.8
Recent study demonstrated that non-pharmacological methods, such as non-nutritive sucking, swaddling,
skin-to-skin care, facilitated tucking, rocking/holding, and music, can be effective in reducing pain in
neonates in the NICU. Given that infants in the NICU are unable to verbally express their pain, effective
pain management is crucial. Non-pharmacological interventions offer a safe and feasible option for pain
relief in this population.9
Anatomical, physiological, and behavioral studies suggest that neonates can perceive pain, but since they
are unable to communicate verbally, behavioral and physiological indicators are used to assess their pain
responses. Behavioral indicators of pain in neonates include facial expressions and body movements.
Facial expressions such as brow bulge, eye squeeze, nasolabial furrow, and mouth movement are
commonly observed in neonates experiencing pain. Similarly, body movements involving the arms,
hands, legs, and feet are also indicative of pain in neonates. Excessive crying is another significant
behavioral indicator of pain in this population. A previous study has suggested that strong and prolonged
crying can indicate a strong pain response among neonates.10
Despite the need for further research to establish conclusive evidence, swaddling has shown promise in
reducing pain response to heel lance procedures in both full-term and premature neonates. Breastfeeding,
topical anesthetics, sweet-tasting solutions, and a combination of topical anesthetics and breastfeeding
have been found to provide benefits in reducing vaccine injection pain in infants and children, although
further research is needed to establish conclusive evidence. For adults, the data is limited, but some
evidence suggests that topical anesthetics and vapocoolants may provide some relief from injection
pain.11,12
Swaddling is a promising, cost-effective non-pharmacological technique for reducing pain and distress
among newborns undergoing painful medical procedures, and its effectiveness has been demonstrated in
various countries. In this study, the researcher aimed to assess the effectiveness of swaddling among
newborns during invasive procedures in selected hospitals in Madurai. Given the need for safe and
effective non-pharmacological pain management methods for neonates, healthcare providers play an
active role in pain management, which can help parents cope with the stress related to their neonates'
painful situations. Therefore, the study aimed to evaluate the effect of swaddling on pain management
during heel prick procedures among neonates admitted to the neonatal intensive care unit.
PROBLEM STATEMENT
A Quasi experimental study to assess the effect of swaddling on management of pain during heel prick
among neonates admitted in neonatal intensive care units at selected hospitals, Punjab.
OBJECTIVES
1. To assess the level of pain during heel prick in control care group.
2. To assess the level of pain during heel prick with swaddling in experimental group.
3. To compare the level of pain during heel prick between experimental (swaddling) and
control care group.
 4. To determine the association between level of pain with selected socio-demographic
variables.
OPERATIONAL DEFINITIONS-
1. Swaddling:Swaddling is the practice of wrapping a baby snugly in a blanket or cloth for
warmth and security.
2. Pain:Itsrefers to the level of pain experienced by neonates during heel prick procedures,
as measured by the Neonatal Infant Pain Scale.
3. Neonates:Neonates refer to babies who are aged from 0 to 28 days old and are admitted
to the neonatal intensive care unit.
4. Heel prick: It refers to blood collection method that involves making a small puncture in
the heel of a neonate to obtain a blood sample for glucose monitoring.
HYPOTHESIS-
1. H1- There will be a significant difference in the level of pain experienced during heel
prick procedures between the experimental group (swaddling) and the control group
(conventional care).
2. H2- There will be a significant association between the levels of pain experienced during
heel prick procedures and selected sociodemographic variables.
DELIMITATIONS
1. The study will be conducted at NICU in selected hospitals Dist Fazilka,Punjab.
2. Data will be collected allotted particular time limits.
REVIEW OF LITERATURE
The critical stage of research is the literature review, which involves a thorough and methodical
investigation of relevant publications. A literature review is essential in providing a basis for the research
and can also spark innovative ideas. Comprehensive literature reviews are conducted through an
exhaustive analysis of published and unpublished materials such as books, reports, and documents.
Britto C et al. (2017) carried out a randomized controlled trial to compare the effectiveness of different
pain control interventions in preterm neonates. The study was conducted in a Level-3 University affiliated
neonatal intensive care unit and involved 200 neonates with a gestational age of 26-36 weeks who
required heel-prick for bedside glucose assessment. The neonates were randomly assigned to three
groups: Kangaroo mother care with music therapy, Kangaroo mother care only, or a control group with no
additional interventions. All groups received expressed breast milk with cup and spoon as the baseline
pain control intervention. The researchers assessed pain using the Premature Infant Pain Profile (PIPP)
score on recorded videos. The mean birth weight and gestational age of the neonates were 1.9 (0.3) kg
and 34 (2.3) weeks, respectively. The results of the analysis of variance showed a significant difference in
the total PIPP score across the groups.13
Asadi MH et al. (2018)conducted a study to evaluate the pros and cons of swaddling, with a focus on the
traditional Persian Medicine perspective. They consulted books by renowned Persian traditional medical
scholars and modern medical literature available in databases. The study found that while better sleep for
babies was believed to be an advantage of swaddling, it was associated with disadvantages such as the
risk of Sudden Infant Death Syndrome (SIDS) and hip joint dislocation. However, in Persian traditional
medicine, swaddling was considered a treatment for joint dislocation during labor or a way of preventing
dislocations that might occur while carrying the infant. To address these concerns, the study proposed a
careful swaddling technique that not only reduced the mentioned disadvantages but also provided positive
effects such as improved sleep and preserved body temperature for the newborn. The study highlighted a
significant difference between traditional medical scholars' ideas and those of people on swaddling.
Therefore, by combining Iranian experience and modern medical findings with the works of Iranian
scholars, a different definition of swaddling can be provided.14
Mangat AK, et al. (2018) conducted a study to assess the safety and efficacy of non-pharmacological
pain relief methods in newborn infants and determine which techniques were most effective. The study
focused on non-pharmacological techniques in preterm or term infants and excluded studies that
compared pharmacological and non-pharmacological interventions or did not use a behavioral
measurement of pain, such as the Premature Infant Pain Profile (PIPP) or the Neonatal Infant Pain Scale
(NIPS). Out of the total 26 studies reviewed, 10 were conducted in preterm infants, 12 in term infants, and
4 in both preterm and term infants. Newborn infants in NICUs undergo many necessary but painful
procedures during their hospitalizations. The implications of the pain associated with these procedures
and the types of pain relief provided to the infants have significant implications for both short- and long-
term outcomes. The evidence for non-pharmacological analgesia is limited and requires further study.
While most techniques appear to be safe and relatively effective, their effects on the infants' long-term
outcomes are unknown, particularly when combined with pharmacological analgesia.15
Desai S, et al. (2017) randomized controlled clinical trial conducted a study over a six-month period in a
Level III neonatal Intensive Care Unit. In the first phase, they used the premature infant pain profile
(PIPP) score to assess pain associated with suctioning in preterm neonates on assisted ventilation. In the
second phase, they evaluated the effectiveness of expressed breast milk (EBM), swaddling, and sucrose in
relieving pain during suctioning in neonates on assisted ventilation. The study found a significant increase
in pain associated with suctioning in preterm neonates on assisted ventilation, with a pre-procedure PIPP
score of 7.90 ± 2.50 and a procedural PIPP score of 13.63 ± 2.57 (P < 0.05). However, the post-
intervention mean procedural PIPP score was not significantly different between the EBM, swaddling,
and sucrose groups (P = 0.24). The study concluded that suctioning is painful for preterm neonates on
assisted ventilation and that there was no significant difference in pain relief between EBM, swaddling,
and sucrose during suctioning.16
RESEARCH METHODOLOGY
The methodology is a proper study or analysis of all the methods used in the research.
This chapter outlines the methodology adopted for the study,including the research approach, research
design, research study setting, population, sample and sample technique, inclusion and exclusion criteria,
selection and development of tools, pilot study, data collection procedure, ethical considerations, and plan
for data analysis.
Research approach
Research approaches are plans and the procedures for research. that span the steps from
broad assumptions to detailed methods of data collection, analysis, and interpretation.
A quantitative research approach will be adopted to assess the effect of swaddling on management of pain
during heel prick among neonates admitted in Neonatal intensive care unit at selected hospitals, Punjab.
Research design
A research design is a framework that has been created to find answers to research questions.
For the present study A quasi experimental research design will be adopted to assess the effect of
swaddling on management of pain during heel prick among neonates admitted in Neonatal intensive care
unit at selected hospitals, Punjab.
Research setting
Research setting is the physical, social, or experimental context within which research is
conducted.
The study will be conducted neonates admitted in Neonatal intensive care unit at selected hospitals,
Punjab.
Population
A population is the complete set group of individuals, whether that group comprises a nation or
a group of people with a common characteristic.

The target population is neonates admitted in Neonatal intensive care unit.

Accessible Population
The accessible population is the portion of the target population that the researcher can access,
Neonates admitted in Neonatal intensive care unit at selected hospitals, Punjab.
Sampling Technique
Sampling is a technique of selecting individual members or a subset of the population to make
statistical inferences from them and estimate the characteristics of the whole population.

Purposive sampling technique will be adopted for the selection of subjects.

Sample Size
60 neonates will be taken for the study. 30 neonates will in experimental group and 30 neonates will in
control group
Sampling Criteria
Inclusion criteria:
• Neonates undergoing a heel prick (blood glucose monitoring).
• Neonates who will be present at the time of study.
• Neonates who’s parent will be willing to participate and have given written informed consent
for the same.
Exclusion criteria:
• Neonates who will be critically ill not maintaining oxygen saturation, sedated, congenital
anomaly grade III or IV, intra-ventricular haemorrhage, patient undergone surgery and any
tissue breakdown or inflammation of either heel.Neonates who will be requiring more than
one prick during one heel prick procedure.
Selection and development of tools:
It will be prepared and finalized with extensive review of literature, consultation and discussion with
experts of nursing.
Description of tool

Part A: Information Data Sheet. It will consist of information such as age, sex, days in NICU,
Diagnosis

Part B: Pain Assessment:The level of pain will be assessed in neonates after 32 week of
gestational age is NIPS (Neonatal infant pain scale).

Validity of Tool

10 Nursing professor will validate the instrument.

Pilot Study
Pilot study will be conducted on minimum 10% of the total sample size.
Content Validity

Content validity of tool will be determined by expert’s opinion on the relevance of items Reliability of
Tool

The reliability will be assessed using the Cronbach's alpha method.

Ethical Consideration
Ethical clearance will be taken form research and ethical committee of Meera Medical Institute of
Nursing and Hospital, Abohar for the study to be conducted. Apart from this, written informed consent
will be taken from parents of neonate and permission will be taken from Chief Medical officer of selected
hospitals and then permission will be obtained from head of NICU Incharge.Confidentiality & privacy of
the study subjects will also be maintained.

Data Collection Procedure

After receiving formal permission from senior authorities of chosen hospitals Punjab., data will be
gathered. The sample will be selected after obtaining their consent from parents. The data will be
collected using information datasheet sheet, pain assessment scale.

Data Processing
Data will be processed and analyzed with editing, coding, classification and tabulation

Plan of Data Analysis

The data will be analyzed according to objectives of the study using descriptive and inferential statistics
DISCUSSION
Discussion will be based on statistical analysis, current trends and previously related research studies
 RESEARCH APPROACH
Quantitative research approach

RESEARCH DESIGN
Quasi-experimental study

RESEARCH SETTING
Neonatal intensive care unit at selected hospitals, Punjab.

TARGET POPULATION
Neonates admitted in Neonatal intensive care unit

ACCESSIBLE POPULATION
Neonates admitted in Neonatal intensive care unit at selected hospitals, Punjab.

SAMPLE AND SAMPLING TECHNIQUE

60 neonates with purposive sampling technique

TOOL AND METHOD OF DATA COLLECTION

Part A: Information Data Sheet
Part B: NIPS (Neonatal infant pain scale).
Observation Methods

ANALYSIS AND INTERPRETATION

Differential and inferential statistics

FINDING AND INTERPRETATION OF RESULTS

Figure 1: Schematic representation of Research Methodology

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Positions on Orogastric Tube Insertion Pain amongPreterm Neonates. IOSR Journal of
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2. Malakian A, Dehdashtiyan M, Aramesh MR, Aletayeb SM, Ghazanfari F. Assessment of
cooling effect on neonatal pain during heel prick blood sampling: A randomized clinical
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