EFFECTIVENESS OF BREAST FEEDING AND MATERNAL HOLDING ON PAINFUL RESPONSES AMONG TERM NEONATES UNDERGOING HEEL LANCE FOR NEWBORN SCREENING AT KMCH COIMBATORE.

Reg. No. 301415451

A DISSERTATION SUBMITTED TO THE TAMILNADU

Dr. M. G. R. MEDICAL UNIVERSITY, CHENNAI, IN PARTIAL

FULFILMENT OF REQUIREMENT FOR THE DEGREE OF

MASTER OF SCIENCE IN NURSING

OCTOBER 2016

CERTIFICATE

This is to certify that the Dissertation entitled “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF BREAST FEEDING AND MATERNAL HOLDING ON PAINFUL RESPONSES AMONG TERM NEONATES UNDERGOING HEEL LANCE FOR NEWBORN SCREENING AT KMCH, COIMBATORE” is submitted to the faculty of nursing, THE TAMILNADU Dr. M. G. R. MEDICAL UNIVERSITY, CHENNAI, by Reg. No. 301415451 in partial fulfilment of requirement for the degree of Master of Science in Nursing. It is the bonafide work done by her and the conclusions are her own. It is further certified that this dissertation or any part thereof has not formed the basis for award of any degree, diploma or similar titles.

Prof. DR. S. Madhavi, M.Sc. (N), Ph.D.,

Principal,

KMCH College of Nursing,

Coimbatore – 641014

Tamil Nadu

EFFECTIVENESS OF BREAST FEEDING AND MATERNAL HOLDING ON PAINFUL RESPONSES AMONG TERM NEONATES UNDERGOING HEEL LANCE FOR NEWBORN SCREENING AT KMCH COIMBATORE.

APPROVED BY DISSERTATION COMMITTEE ON DECEMBER 2015

1. RESEARCH GUIDE: Prof. DR. S. Madhavi, M.Sc. (N), Ph.D., Principal, KMCH College of Nursing, Coimbatore – 641014

2. CLINICAL GUIDE : Prof. DR. Mariammal Pappu M.Sc.(N),Ph.D., (BS) Head of the Department Department of Pediatric Nursing KMCH College of Nursing, Coimbatore - 641014

3. MEDICAL GUIDE : Dr. Ashwath. D., DCH., M.D., D.N.B., Consultant in & Neonatology Kovai Medical Center & Hospital Ltd., Coimbatore -641014

A DISSERTATION SUBMITTED TO THE TAMIL NADU Dr. M. G. R. MEDICAL UNIVERSITY CHENNAI, IN PARTIAL FULFILLMENT OF REQUIREMENT FOR THE DEGREE OF MASTER OF SCIENCE IN NURSING

OCTOBER 2016

ACKNOWLEDGEMENT

I place my deep sense of admiration to God Almighty for his grace, blessing, guidance and support which strengthened me in the research process and sustained me throughout this endeavor.

First and foremost I offer my sincere gratitude to our Chairman Dr. Nalla G. Palaniswami, M.D.,AB (USA), Chairman And Managing Director, Kovai Medical Center And Hospital and our Trustee Dr. Thavamani D. Palaniswami M.D.,AB (USA), Managing Trustee, Kovai Medical Center And Hospital for giving me an opportunity to undertake my Post Graduation programme in this esteemed institution.

I grab this occasion to express my deep sense of gratitude to Prof. DR. S. Madhavi, M.Sc. (N), Ph.D., Principal, KMCH College of Nursing, who was my Research guide who had supported throughout my study with her valuable knowledge in research and in statistics.

I am extremely thankful to Prof. (Mrs.) Sivagami .R. M, M.Sc. (N)., Vice Principal KMCH College of Nursing for her generous support, encouragement and timely advice to fulfil this work.

Words are inadequate in offering my thanks to Prof. DR. Mariammal Pappu, M.Sc. (N), Ph.D., (BS) HOD of Pediatric Nursing KMCH College of Nursing, my clinical guide for her expert advice, extensive guidance and consultation, continued help and encouragement right from the selection of the problem to the conclusion of this study.

I take immense pleasure in thanking my Medical guide Dr. Ashwath. D., DCH., M.D., D.N.B., Consultant in Pediatrics & Neonatology, for his guidance and direction for this study.

I wish to record my gratitude to Prof. (Mrs.) N. B Mahalakshmi, M.Sc. (N)., Mrs. R. Sasikala M.Sc. (N) Asso. Prof., Mrs. Alice Rani M.Sc. (N) Assist. Prof., and Pediatric nursing faculty, who have not only served as my superiors but also encouraged sincerely throughout my dissertation process.

I wish to express my sincere thanks to all the mothers and their babies whose sufferings led the way for my study.

I express my sincere gratitude to Mrs. Jane Ebenezer, Nursing supervisor, and all the staff nurses in post natal wards, who helped me to complete my study successfully.

I am exceedingly thankful to Mrs. Vennila., Statistician, KMCH College of Pharmacy, for her guidance in statistical analysis and interpretation of data during the study.

Thanks also goes to Mr. Damodharan, Chief Librarian and Assistant Librarians, KMCH College of Nursing for their whole hearted help and assistance in search of references to update the content. I would like to extend my sincere thanks to the King of Kings for the professional quality of the computer work to complete the form of my study.

A most sincere thanks to Mrs. A. Buvaneswari, M.A., M.Phil, Assistant Professor who edited my study in the present form, which express what it originally mean.

Above all I am so deeply indebted to my parents, brothers and sisters, my husband Mr. Anoop Kurien Abraham and all of my family members for permitting me to undertake this post graduate program, for their help, motivation, prayer, economic and moral support and unconditional love and cooperation throughout my study without that my dream would never have come true. My special thanks also goes to my classmates and friends, especially Ms. Anusha. R and Ms. Soumya Babu who directly and indirectly encouraged and helped me throughout this study.

TABLE OF CONTENTS

CHAPTER CONTENTS PAGE NO I INTRODUCTION 1-8 NEED FOR THE STUDY 2 STATEMENT OF THE PROBLEM 5 OBJECTIVES OF THE STUDY 5 OPERATIONAL DEFINITIONS 5 HYPOTHESIS 6 ASSUMPTIONS 6 CONCEPTUAL FRAMEWORK 7-8 II REVIEW OF LITERATURE 9-14 III RESEARCH METHODOLOGY 15-20 RESEARCH DESIGN 15 VARIABLES UNDER THE STUDY 15 SETTING OF THE STUDY 16 POPULATION OF THE STUDY 16 SAMPLE SIZE 16 SAMPLING TECHNIQUE 17 CRITERIA FOR SAMPLE SELECTION 17 DEVELOPMENT AND DESCRIPTION OF THE TOOL 18 DEVELOPMENT OF INTERVENTION 18 VALIDITY AND RELIABILITY OF THE TOOL 19 PILOT STUDY 19 PROCEDURE FOR DATA COLLECTION 19 METHOD OF DATA ANALYSIS 20 IV DATA ANALYSIS AND INTERPRETATION 21-43 DISCUSSION, SUMMARY, CONCLUSION, V IMPLICATIONS, LIMITATIONS AND 44-53 RECOMMENDATIONS ABSTRACT 54 REFERENCES 55-60 APPENDICES

LIST OF TABLES

TABLE NO TITLE PAGE NO

1. Distribution of Demographic variables of Neonates 22

Description of mean Physiological parameters of in both 2. 28 groups Description of pain scores in Breast feeding group 3. 32

Description of pain scores in Maternal holding group 4. 33

Description of Level of pain among Neonates 5. 34

Description of duration of cry according to their age in 6. 36 group Description of duration of cry according to their age in 7. 36 Maternal holding group Comparison of pain scores of Behavioral parameters among 8. 37 Neonates undergoing heel lance in both groups Comparison of pain scores of Physiological parameters among 9. 38 Neonates undergoing heel lance in both groups Comparison of mean pain scores among breast feeding and 10. 40 Maternal holding groups Comparison of Neonate’s duration of cry according to their age 11. 41 in Breast feeding group Comparison of Neonate’s duration of cry according to their age 12. 41 in Maternal holding group Association between the Neonate’s demographic variables and 13. 42 the pain scores in Breast feeding group Association between the Neonate’s demographic variables and 14. 42 the pain scores in Maternal holding group

LIST OF FIGURES

FIGURE NO FIGURES PAGE NO Conceptual framework- Modified Gate Control Theory 1. 8 By Melzack And Wall (2012) Distribution of Neonates according to the Age in 2. 23 Breastfeeding group Distribution of Neonates according to the Age in 3. Maternal Holding group 23

Distribution of Neonates according to the Gestation in 4. 24 Breastfeeding group Distribution of Neonates according to the Gestation in 5. 24 Maternal Holding group Distribution of Neonates according to the Sex in 6. 25 Breastfeeding group Distribution of Neonates according to the Sex in 7. 25 Maternal Holding group Distribution of Neonates according to the Birth weight 8. 26 in Breastfeeding group Distribution of Neonates according to the Birth weight in 9. 26 Maternal Holding group Distribution of Neonates according to the Mode of 10. 27 delivery in Breastfeeding group Distribution of Neonates according to the Mode of 11. 27 delivery in Maternal Holding group Distribution of Heart rate among the Breastfeeding group 12. 29 before and after heel lance. Distribution of Heart rate among Maternal holding group 13. 29 before and after the heel lance Distribution of Saturation among the Breastfeeding 14. 30 group before and after heel lance.

Distribution of Saturation among Maternal holding 15. 30 group before and after heel lance. Description of mean Heart rates in both groups before and 16. 31 after heel lance Description of mean Saturation in both groups before and 17. 31 after heel lance Description of Pain level among neonates who 18. 34 underwent heel lance. Distribution of pain scores of neonates in Breastfeeding 19. 35 and Maternal holding group Distribution of duration of cry in Breastfeeding and 20. 35 Maternal holding group Comparison of mean scores of Behavioral cues of pain 21. 39 among Breastfeeding and Maternal holding groups Comparison of mean scores of Physiological cues of pain 22. 39 among Breastfeeding and Maternal holding groups Comparison of mean pain scores among the 23. 40 Breastfeeding and Maternal holding group

LIST OF APPENDICES

SL NO TITLE

I Demographic characteristics of the Neonates

II Premature Pain Profile by Stevens (1996)

III Observational Performa for assessing Duration of cry in Neonates

IV Copy of permission letter to conduct the study

V Copy of Ethical clearance letter to conduct study

VI Copy of certification for content validity

VII List of experts

CHAPTER I

INTRODUCTION

Neonates admitted to the hospital may encounter pain as a result of diagnostic or therapeutic interventions or as a consequence of a process. Neonates cannot verbalize their pain experience sorely on others to recognize, assess and manage their pain. Even if not expressed through cognizant , neonates may bear prompt or long term consequences, if presented to painful trauma for lengthy periods. Neonates will have hormonal, physiological and behavioural responses when presented to noxious stimuli. By identifying behavioural and physiological responses to pain, adequate can be given. Tools that help the clinical assessment of pain are guarantee consistency between clinicians. Pain is considered as the 5th vital sign. (Kendrick. A., Twomey. B., 2016).

Pain is difficult to measure and even more perplexing when its sufferers are very young or preverbal. This is particularly factual of newborn , both full and preterm. For years, health-care providers in the United States have cared for infants without viewing pain as one of the significant threats or difficulties in making treatment decisions, this was not because anyone wanted to harm babies. Superficial observations agreed that pain medications had some threats along with their benefits, and that infants appeared to forget pain anyway. (Giboney P. G., 2004). An observational study was conducted in paediatric teaching hospital with a strategy of pain assessment during a heel lance procedure. The study included 20 neonates who underwent heel lance. The behavioural dimensions like facial expressions, body movements, crying characteristics and the physiological measure of heart rate were assessed. The study concluded that the neonate were responsive to three behavioural dimension and heart rate during the heel lance. (Harrison. D., 2003).

Neonates are at risk of Neuro-developmental impairment as a result of preterm birth (i.e., the least and sickest) are most likely to be open to the maximum number of painful stimuli in the NICU. In spite of the fact that there are major gaps in our knowledge regarding the most effective way to avoid and let go pain in neonates, verified and safe therapies are currently been used for routine minor yet painful procedures. Every health care team caring for neonates need to implement an effective pain-prevention program, which includes approaches for routinely assessing pain,

1 minimizing the number of painful procedures performed, and successfully using pharmacologic and non-pharmacologic remedies to eliminate pain. (Patracia. E. et.al. 2016). Randomized clinical trial was done to assess the efficacy of breast-feeding with maternal holding as compared with maternal holding without breastfeeding in relieving painful responses during heel lance in full-term neonates. 128 full-term newborn in 4 to 6 days of life were included in the study. The neonates were randomly assigned into 2 equivalent groups, they were either breast-fed with maternal holding or were held in their mother’s lap without giving breastfeeding. The painful responses were measured simultaneously. 2 neonatal nurses were blinded to the purpose of the study. Outcome was measured with the Premature Infant Pain Profile scale. Independent t test showed significant differences (t =−8.447, P = .000) in pain scores. Breastfeeding with maternal holding group had less score than the other. (Obeidat, H. M., & Shuriquie, M. A., 2015). The study was conducted to evaluate the effectiveness of breastfeeding in reducing procedural pain in neonates. Data on appropriate results were extracted and the effect size was estimated and reported as relative risk difference and measured mean difference. Neonates who were in the breastfeeding group had statistically significantly less increase in the heart rate, reduced amount of crying time and reduced duration of crying compared to no intervention group. (Shah. P. S., 2006).

To minimize procedural pain in neonates a study was done by utilizing breastfeeding as an intervention. The study demonstrated that breastfeeding ought to be utilized to minimize the pain in neonates. The main aim was to compare the breastfeeding with control group. The breastfeeding group had essentially less increment in the heart rate, lessened extent of crying time and diminished time of crying compared with the non-breastfeeding group. (Prakash, Lucia, Vibuti Shah, 2007).

NEED FOR THE STUDY

Every newborn and premature baby feels pain. Children remember pain, and may avoid forthcoming medical care because of painful experiences in a hospital. Untreated pain suffered early in life can have deep and long-lasting effects on social and physical development, and can cause permanent changes in the that will disturb future pain experience and development. When children suffer, so do their

2 parents, family, and caregivers, and caring for a child with chronic pain can cause the family emotional and financial stress. Prolonged pain may have a better prognosis if treated early in life than if it is allowed to persist into adulthood. Children’s pain isn’t treated sufficiently, even though we do have the ability to treat or prevent most pain. Most pain can be either prevented, treated, or at least reduced using inexpensive medications, emotional, and/or physical techniques. In spite of this, utmost children in the world do not receive adequate treatment. (International Association for the Study of Pain-IASP, 2012).

In a Cochrane survey, the scientists included 11 concentrates on analyzing the impacts of breastfeeding or breast milk on intense procedural pain; the most reduced neonatal facial score (2.3 versus 7.1), most reduced cry span (5 versus 49), and diminishing in parasympathetic tone (–2 versus 1.2). Bottle feeding was indicated preferable impacts over alternate interventions, however was not as successful as breastfeeding. Breastfeeding amid heel prick testing was observed to be the best strategy for painful relief. (Shah, Aliwalas, Shah, 2009).

The feasibility of breastfeeding in decreasing pain in babies experiencing blood collection for newborn screening was done in the year 2008. The study comprised of 60 full term infants, 31 in the experimental group and 29 in the control group. The experimental group was breastfed 5 minutes prior, amid, and for 5 minutes after the blood collection procedure. Neonates in the control group were held in moms' arms yet not fed or given a soother. Sucking recurrence was just assessed in the experimental group. Compared and the control group, the experimental group had essentially lower, Neonatal Facial Activity Coding System and rest wake state scores and heart rates changes. In the experimental group sucking recurrence was most astounding amid the initial 5 minutes of breastfeeding before the technique. The distinctive periods of the strategy were assessed independently; the breastfeeding intercession secured the period from 5 minutes before the blood collection until the end of recuperation; rest wake state was completely surveyed and the sucking recurrence in the experimental group was evaluated amid the method. The study presumed that breastfeeding was successful in diminishing pain brought about by blood gathering for newborn screening. (Leite, Morraes. A. et.al 2008)

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Non- pharmacological treatments (excluding breast milk, sucrose, and music) were examined to determine the efficacy for pain reactions after an acutely painful procedure. 13 different types of non-pharmacological measures were commonly investigated. 51 randomized controlled trials were included involving 3396 participants. There was sufficient evidence to recommend , sucking related interventions, and or facilitated tucking, rocking or holding interventions for both pain reactivity and immediate pain regulation. (Pillai. R., Nicole, Kara, et.al, 2012). Pain assessment was evaluated by DAN scale (Douleur Aigue Nouveau ne scale). 200 healthy neonates were assessed during heel lance. 100 were in experimental and 100 in control group. The experimental group was breastfed. The findings reveal that the pain score were significant in the two groups; the researcher found that breastfeeding is having an effect. (Uga. E, Candriella. M., 2008).

Breastfeeding provides pain relief for newborn babies undergoing painful procedures. There are different forms of non-pharmacological strategies that may be used to reduce pain in babies, such as holding, swaddling them, sucking on a pacifier, or giving sweet solutions (such as sucrose or glucose). Studies have been done in full-term babies and they have shown that breastfeeding is effective by demonstrating that it reduces babies' crying time and reduces different pain scores that have been validated for babies. Breast milk given by syringe has not shown the same efficacy as breastfeeding itself. (Herbozo, Aliwalas. et.al, 2012)

A neuroimaging study was conducted to evaluate the effectiveness of maternal holding versus oral glucose administration to assess the cortical activation during the heel prick procedure. 20 newborns were given 2 ml of oral sucrose solution two minutes before the heel prick, and blood sampling was performed with the newborn lying supine on a changing table. Twenty newborns were held by their mothers, beginning 2 minutes before the heel prick and throughout the procedure the mothers sat comfortably on a chair, kept their dressed newborn in their arms, and were not allowed to talk to him or her. An increase in the oxy-hemoglobin level during the heel prick was considered an estimation of cortical activation. They concluded that analgesia may be mediated by multisensory stimulation in the context of an emotionally significant attachment relationship between the newborn and his or her mother. (Bembich .S. Gabriele. C, et.al 2015)

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During the clinical posting in postnatal wards, the researcher found that neonates are undergoing number of painful procedures like venipuncture, collection of blood samples and heel lancing. Heel lancing was mainly done for newborn screening test and it was done routinely for neonates according to their parent’s willing. There are different types of non- pharmacological measures which can be effectively used to reduce pain among neonates while exposed to painful procedures. So the researcher had chosen two non- pharmacological measures such as Breast feeding and maternal holding to find the effectiveness in reducing pain among Neonates.

STATEMENT OF THE PROBLEM

A comparative study to assess the effectiveness of Breastfeeding and Maternal holding on painful responses among term Neonates undergoing heel lance for Newborn screening at KMCH, Coimbatore.

OBJECTIVES OF THE STUDY:

The objectives of the study:

 Assess the painful responses among Neonates undergoing heel lance in Breastfeeding and Maternal holding groups.

 Compare the pain scores among Neonates with Breastfeeding and Maternal holding.

 Associate the Neonate’s demographic variables with the level of pain who were on Breast feeding during heel lance.

 Associate the Neonate’s demographic variables with their level of pain who were on Maternal holding during heel lance.

OPERATIONAL DEFINITIONS:  Painful responses: unpleasant sensory and emotional response associated with tissue damage during the heel lance expressed as behavioral and physiological cues assessed by premature infant pain scale.  Neonate: refers to a baby’s age ranging from birth to 28 days with the birth weight of more than 2.5kg.

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 Breastfeeding: refers to the neonates who were breastfed and held in their mother’s lap while their mothers are seated reclining on a comfortable chair and the neonate is observed for PASS (Positioning, attachment, sucking and swallowing).  Maternal holding: refers to neonates who are held in their mother’s arms with heel exposed at the time of heel lance.

HYPOTHESIS H1: There is a significant difference in the pain response of Neonates on Breastfeeding than the Neonates on Maternal holding during heel lance.

ASSUMPTIONS  Neonates can experience pain.  Breastfeeding is the process itself leading to the activation of endogenous through orogustatory stimulation and it contains tryptophan which has nociceptive effect.

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CONCEPTUAL FRAME WORK

Gate control theory was described by Melzack and Wall in 1965. The theory has been revised in the year 2012. This theory explain about a pain- modulating system in which a neural gate present in the can open and close thereby modulating the perception of pain.

The three systems located in the spinal cord act to influence perception of pain, mainly

 The substantia gelatinosa in the dorsal horn,  The dorsal column fibers, and  The central transmission cells o The noxious impulses are influenced by a “gating mechanism.” o Stimulation of the large- diameter fibers inhibits the transmission of pain, thus “closing the gate.” and the stimulation of smaller fibers, thus opens the gate. o Gate is opened by  Physical factors - Bodily injury  Emotional factors - Anxiety & Depression  Behavioral factors - Attending to the injury and concentrating on the pain o Gate may be closed by:  Physical pain - Analgesic remedies  Emotional pain - Being in a ‘good’ mood  Behavioral factors – Concentrating on things other than the injury.

In the present study, the neonates experience pain because of bodily injury which opens the gate in both groups, but the concept of behavioral factors were emphasized as breast feeding while heel lance, the breast milk activates the endogenous opioid which contain nociceptive effects on pain. So pain is not perceived. So the newborn in breastfeeding group showed stable physiological parameters and reduced pain scores and cry. In maternal holding, as the neonate are held in their mother’s arm while heel lance, only smaller fibers are stimulated and the behavioral factors mainly emphasizes on not concentrating on pain. So gate is opened and pain is perceived. They showed increased heart rate, reduced saturation prolonged cry and increased pain scores.

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Breast milk contains endogenous DECREASED PAIN

tryptophan HEART RATE NOT stimulating the large ACCELERATED

diameter fibers. Gate SATURATION NOT FACTORS is closed. DROPPED

REDUCTION IN CRY PHYSICAL: Bodily injury (Heel lance) (<2days 31.79 sec, >2days 31.38 sec) BEHAVIORAL: OUTCOME Concentrating on pain Breastfeeding is GATE superior in pain control than OPENED maternal holding DEMOGRAPHIC during heel lance VARIABLES

 Age  Gestation INCREASED PAIN HEART RATE  Sex ACCELERATED  Birth weight Maternal holding is the SATURATION  Mode of delivery form of not concentrating DROPPED on pain which stimulates smaller fibers. Gate is not PROLONGED CRY closed. Pain is perceived. (<2days 124.08 sec, >2days 139.07 sec)

Figure No. 1.MODIFIED GATE CONTROL THEORY BY MELZACK AND WALL (2012)

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CHAPTER II

REVIEW OF LITERATURE

Review of literature is an essential part of any research study, it familiarizes the investigator with previous investigations related to one’s field of interest, the various methods and procedures which can be perused. It also provides an opportunity to localize the related information and interest. Thus it offers general guidelines for the execution of the research studies. (Polit and Hungler, 1999). The extensive review of literature has been done and it is organized according to the following headings:

Section A: Studies related to effectiveness of Breastfeeding during painful procedures. Section B: Studies related to effectiveness of Maternal holding during painful procedures. Section C: Studies related to painful perception in Neonates.

Section A: Studies related to effectiveness of breastfeeding during painful procedures. Breast-feeding is a common way of promoting bonding and affection between neonates and mothers. A study was conducted to assess the effectiveness of breast- feeding on procedural pain amid term neonates in Chennai. The cues evaluated were facial expression, pattern of breathing, arms, legs and nature of cry on 60 term neonates. Breast-feeding before procedural pain amid term neonates and their intensity of pain perception was reduced. Nurses can inculcate the breast-feeding practices before painful procedures amid neonates as evidence based practice for evaluating the immense developmental outcome. (Judie. A., Jasmine. C., 2011). Effectiveness of breastfeeding during neonatal immunization injections showed pain reduction in infants. 60 infants in experimental group and 60 infants in control group were selected for the study. Pain responses of infants during and after immunization were observed. Infant’s heart rate and length of crying for both groups were calculated. Findings discovered that the crying time was lesser in breastfed group than in the control group with a statistically significant difference in the duration of crying during and after immunization. (Razek, A. A., & El- Dein, N. A. 2009).

A sample of 101 term neonates was randomly allocated to breastfeeding during blood sampling and to oral administration of one ml of sucrose solution. The study

9 revealed that breastfeeding provides long term analgesic effect for heel lance compared with oral sucrose in term neonates. The main aim of this study was to compare the efficacy of breastfeeding and orally provided sucrose solution in diminishing pain response during heel lance blood procedure. Scores were lower in the breastfeeding group (3.0) than in the sucrose group (8.5). (Fenestrelle. S. 2008). A sample of 102 term neonates requiring a venous blood sampling was used for the study. NIPS were used and neonate’s heart rate, saturation level and duration of crying were noted. The crying time in seconds was less in both sucrose i.e. 9.56+ or -12.96 and breastfeeding 28.62+ or -33.71 than the control group. No difference was assessed between sucrose and breastfeeding group. (Efe, Savaseer, 2007)

The pain relieving effect of breastfeeding during immunization shots in healthy neonates showed effectiveness in reducing pain. 66 healthy were randomized to be breastfed before, during, and after the shot or to be given the shot according to routine clinic procedure (no breastfeeding). The heart rate and saturation levels were almost the same in both groups. They concluded that breastfeeding, holding, and skin-to-skin contact significantly reduced crying. (Efe, Ozer, 2007)

Effect of breast feeding on pain, a clinical trial design was done in 130 newborns. Samples were allotted randomly in two groups, the breastfeeding group, feeding was initiated two minutes before injection and continued for 45 seconds. In the control group shot was made without breast feeding. Pain assessment was performed and the results showed that in the breastfeeding group of newborns got 4 points and no one got more than 7 points. The control group got 8 points and no one got less than 3 points. The mean of pain severity in case group was 3.5 and in control group were 6.7 and it show significant difference. They concluded that breastfeeding can significantly reduce pain in newborn. Hence they propose that this is the easy method generally for all painful procedure to prevent the development of possible permanent emotional effects in newborns. (Modares. M., Rahim. V. S. F. 2007)

38 neonates were participated in a cross over design where each neonate served as his/her own control. Median pain scores when neonates were being breastfed were compared with those when neonates were not being breastfed. The results revealed that the median pain score of the neonates when breastfed were 1.5 and 4 when not breastfed. The result shows statistically significant differences among the breastfeeding

10 and non-breastfeeding groups. Breastfeeding should be the first choice analgesic during painful procedures in neonates. (Osinaike, B.B., Oyedeji, A. O., et al. 2007)

A randomized control trial was conducted on 180 newborns to assess the efficacy of breastfeeding during venipuncture. Newborns were mainly divided into 45 in four groups. During venipuncture 45 newborns were breastfed, 45 were held in their mother’s arm without breastfeeding, 45 were given 1 ml sterile water as placebo and rest of the newborns were given 30% sucrose solution followed pacifier. Video recording was done and the results revealed that breast feeding and glucose plus pacifier group had less scores compared to other groups. (Carbajal, R., Veerapan, S., et.al. 2003).

Section B: Studies related to effectiveness of maternal holding during painful procedures. Effects of skin-to-skin contact with the mother during heel prick of 59 stable preterm infants were randomly assigned, 31 in intervention and 28 in control group. In intervention group the infants were set aside 15 minutes in skin-to-skin contact prior, throughout heel prick, and in control group infants underwent regular care. All infants were assessed for change in facial action, behavioral state, crying, and heart rate. Skin- to-skin contact stimulated reduction in behavioral actions and less physiological increase during process. It is suggested that skin-to-skin contact be used as a non- pharmacological intervention to relieve acute pain in stable early infants born 30 weeks gestational age or older. (Castral, T., Warnock, F., et al. 2008)

A prospective study was conducted on skin to skin contact to assess the analgesic effect in healthy newborns. 30 newborn infants were subjected randomly to either being held by their mothers in whole body, skin to skin contact or to no intervention throughout a heel lance procedure. Result showed that crying and grimacing were reduced by 82% and 65%, respectively, and heart rate was also reduced among newborns in experimental group. Results revealed that skin to skin contact is remarkably strong intervention against the pain experienced throughout heel stick in newborns. (Gray, L., Watt, L., Blass, E., 2000).

62 preterm neonates at 28 to 36 weeks' gestational age who were expected to stay in the NICU for at least 2 venous sampling procedures were selected for paternal versus maternal kangaroo care. Infants were held in Kangaroo Care for 30 minutes

11 before and throughout the procedure with the neonate’s mother or with the father, and with the other parent in the following session. The Premature Infant Pain Profile and time for heart rate back to normal were the primary outcomes. The result showed at 30 and 60 seconds after the heel lance, infants in maternal Kangaroo Care displayed considerably lower scores on the Premature Infant Pain Profile than when in paternal Kangaroo Care. The differentiation in time to return to KC heart rate before the heel lance was significant, with the time in maternal Kangaroo Care than in paternal KC. Results showed that the mothers were slightly more effective than fathers in decreasing pain response. (Johnston, C., Campbell, Filion, F., 2011). A study was done in 100 full-term infant pain responses while getting a vitamin K injection. Infants were randomized to both receive KC for 10 minutes and remain in a quiet room in the nursery throughout the procedure. NIPS scores were significant. The infants who received KC got less pain scores. (Kashaninia, Sajedi, Rahgozar, Noghabi, 2008). A randomized case control clinical trial was conducted to assess the efficacy of Kangaroo Care to diminish vaccination pain in newborns. 60 newborns were subjected randomly to case and control groups. Case group received 30 minutes of skin to skin contact and control group were put wrapped in a blanket aside the mothers. Researchers revealed that Kangaroo Care may be used to diminish pain intensity in newborns undergoing painful procedures. (Saeidi. R., Asnashari. Z., et.al, 2011). A study was conducted on 24 premature infants in NICU to compare the physiological and behavioral pain cues during heel prick. The intervention chosen by the researcher was skin ti skin contact. The first group got skin to skin contact prior 3 hours with heel prick and followed by also in an incubator. Second group had incubator care and heel prick before skin to skin contact. The physiological and behavioral cues showed reduction in pain scores. (Susan, M., Robert, B., 2005). A randomized controlled double masked crossover trial was conducted on 50 neonates to assess the effectiveness of kangaroo care in short duration of 15 min in decreasing pain while heel prick. Outcome was measured using premature infant pain profile. The findings revealed that the short duration of kangaroo care had benefits in reducing pain in neonates. (Nimbalkar, S. M., Chaudhary, N. S., et.al. 2013). Section C: Studies related to painful perception in neonates Newborn infants who are exposed to a sequence of painful and stressful treatment show a variety of long term effect as older children, including an altered

12 response to pain and exaggerated physiological response to stress. Pain and stress have been shown to induce significant physiological and behavioral reactions in newborn infants, even those born prematurely. There is now evidence that these early events not only induce acute changes, but that permanent structural and functional changes may also result. (Kate Melville, 1999). A prospective study was conducted on 180 newborns who underwent heel lance for newborn screening. Newborns were allocated in 6 groups such as control with no intervention, non- nutritive sucking, holding by mother, oral sucrose solution, oral formula feeding and breast feeding, the study revealed that newborns who were breastfed or received oral formula feed had a great reduction in pain scores. (Weissman, A., Aranovitch, M., et.al. 2009).

A study was conducted among 70 newborn for observing the pain response to a heel lancing procedure. The study concerned video-recording the neonates and decision made by 28 mothers and 17 fathers of other young children. The finding revealed that facial movement and cry was the influential factor for pain ratings been made. Study concluded that the distinct facial movement using NFCS connected with the adult rating. (Grunau, et.al 2004)

A study was conducted from 1999 to 2009, to evaluate the PIPP feasibility reliability and validity. 14 studies were focused construct validation. Feasibility was assessed in 4 studies and 2 studies addressed clinical utility. Out of 48 studies 2 studies were having high methodological quality. So the PIPP was continued to be reliable, valid measure of acute pain. More research with health professionals is necessary to better support the feasibility and clinical utility of this measure. (Stevens. B., Johnston, C., et.al. 2010)

A study was conducted on the development and primary validation of Premature Infant Pain Profile. The main objective of the study was to develop and validate a measure for assessing pain in premature infants that could be used by both medical experts and researchers. By using a prospective and retrospective design the Premature Infant Pain Profile was formulated and validated. Indicators of pain were identified from medical expert and the articles reviewed. Indicators were retrospectively tested using 4 accessible information sets. Infants of different gestational ages undergoing different painful procedures from 3 various settings were used to develop and validate

13 the measure. The largest data set was used to develop the PIPP. The development process included shaping the factor structure of the data, developing indicator and indicator measures and establishing internal consistency. The left over three data sets were utilized to establish construct validity. The PIPP was a newly developed pain assessment measure for premature infants with establishment of content and construct validity. The expediency and feasibility for using the PIPP in clinical practice will be resolute in prospective research in the scientific setting. (Stevens Bonnie, et.al, 1996).

14

CHAPTER III

METHODOLOGY

This chapter details the research design, setting of the study, populations of the study, sample size, sampling technique, criteria for sample selection, description of tools, validity and reliability, data collection procedures and statistical analysis.

RESEARCH DESIGN

Research design adopted for the present study was Randomized Control Trial post- test only design.

The diagrammatic representation of the design as follows

E X1 O1

R

C X2 O1

R- Randomization

E- Breastfeeding group

C- Maternal holding without breastfeeding group.

O1- Observation of behavioral and physiological cues of pain in both group during heel lance

X1- Breastfeeding during heel lance

X2- Maternal holding during heel lance

VARIABLES UNDER THE STUDY

In this study the independent variables were Breastfeeding and Maternal holding and dependent variables were Behavioral and Physiological responses of pain and duration of cry among Neonates undergoing heel lance.

15

SETTING OF THE STUDY

This study was conducted in post natal wards in KMCH, Coimbatore. KMCH is an 800 bedded NABH accredited multispecialty hospital with excellent health care delivery system for the patients and has various specialties like Cardiology, Neurology Orthopedics, Interventional Radiology, Pediatrics, Obstetrics and Gynecology, Oncology etc. Out of 800 beds, 60 beds are allotted for obstetric cases that include antenatal wards, postnatal wards and labor room separately. Approximately 150 deliveries are conducted every month. Nearly 90 mothers undergo normal delivery and 60 of them undergo caesarean section. In KMCH, heel lance is done to screen Congenital Hypothyroidism, Galactosemia, Phenylketonuria, Congenital Adrenal Hyperplasia and G6PD deficiency.

POPULATION OF THE STUDY

The population of the study was all term neonates from birth to 28 days who are subjected to heel lance.

SAMPLE SIZE

Sample size for the study was 80 Neonates, 40 in Breastfeeding group and 40 in Maternal holding group from birth to 28 days who fulfill the inclusion criteria.

16

SAMPLING TECHNIQUE

Permuted Block randomization method was adopted to select the samples for this study.

Total enrolled eligible sample

80

Maternal holding group

20 20 Breastfeeding group

Maternal holding 20 20 group

Breastfeeding group

CRITERIA FOR SAMPLE SELECTION

Inclusion criteria  Both male and female term neonates  Neonates with Apgar score at one and five minutes ranging from 7 -10.  Neonates who were exclusively breastfed.  Neonates who were subjected to heel lance for Newborn screening.

Exclusion criteria  Neonates who are critically ill.  Neonates with congenital malformation.

17

DEVELOPMENT AND DESCRIPTION OF THE TOOL

Premature Infant Pain Profile (PIPP) developed by Stevens Johnston et al., in the year 1996 was adopted for the study. Only demographic variables of neonates were prepared by the researcher. The tool consisted of three sections.

Section A: Demographic variable

Section B: Premature Infant Pain Profile

Section C: Duration of cry

Section A: The demographic variables of the neonates include Age, Sex, Gestational age, Birth weight and Mode of delivery. Section B: Pain assessment tool consist of Premature Infant Pain Profile (PIPP). The scale consist of 2 categories with 4 sub- indicators of varying levels of responses to painful stimuli scoring from 0 to 3. Maximum score is 21 and minimum score is 0-6.  Behavioral cues which includes behavioral state, brow bulge, eye squeeze and Nasolabial furrow.  Physiological cues which includes heart rate and saturation INTERPRETATION OF SCORING:- Less than 6 : minimal or no pain 6 to 12 : moderate pain More than 12 : severe pain The higher the score the greater the level of pain among the neonates undergoing heel lance.

Section C: Observation Performa to evaluate the duration of cry in Breastfeeding and Maternal holding groups.

DEVELOPMENT OF INTERVENTION

The main interventions are;

 GROUP I (Breastfeeding):Neonates undergone heel lance were breastfed and held in their mother’s lap while their mothers, seated reclining on a comfortable chair and the neonate were observed for PASS (Positioning, attachment,

18

sucking and swallowing), and allowed to suck for 10 seconds before heel lance and were continued to suck till the procedure is finished.  GROUP II (Maternal holding: Neonates were held in their mother’s arms with heel exposed at the time of heel lance. VALIDITY AND RELIABILITY OF THE TOOL Content validity of the tool was obtained by submitting the framed tool to the subject experts in the field of neonatology medicine and nursing. The inter rater reliability of the PIPP tool was 0.94 - 0.98. PILOT STUDY Pilot study was conducted for assessing the feasibility of the main study. The sample size was 12 neonates, out of which 6 neonates in Breastfeeding group and 6 neonates in Maternal holding group. The sample selected for the pilot study was not included in main study. Split half method was done to identify the feasibility of the original study. PROCEDURE FOR DATA COLLECTION An ethical clearance was obtained from the ethical committee members of KMCH; and also the permission was obtained from the chairman and the consultant neonatologist of KMCH. The demographic data were collected from the records. Permuted block randomization was used to recruit the neonates to ensure equality and to reduce bias in breastfeeding and maternal holding groups. Here the samples were selected into 4 sets at a time in randomly selected block sizes to ensure a balanced allocation. 80 samples were divided into 4 sets and the researcher randomly selected the samples for the study. All neonates were awake at the time of the procedure. The investigator assessed the baseline heart rate and saturation of the neonates before procedure by using Ohmeda trusat pulse oxymeter for 15 seconds. Breastfeeding neonates were observed for PASS for at least 5 minutes before heel lance and the mothers were instructed to continue breast feeding during the procedure till the procedure finishes. Heel lance procedure was done with a Quikheel lancet, a onetime use instrument with standardized 1.00 mm incision depth. The investigator measured the variation in the heart rate and saturation and duration of cry by observing the pulse oxymeter which is attached to the neonate’s opposite leg on the great toe during heel lance for 30 seconds. Same way the neonates in control group were mummified and held in their mothers arm with heel exposed during the procedure and the investigator

19 measured the variation in the heart rate and saturation and duration of cry by observing the pulse oxymeter during heel lance. In both group the pain were measured by using the PIPP scale and by participatory observation technique.

METHOD OF DATA ANALYSIS The investigator analyzed the data obtained by using descriptive statistics such as mean, percentage calculations and inferential statistics such as t – test and association of demographic variables with level of pain with chi- square. The statistical information is represented in the following chapter.

20

CHAPTER IV DATA ANALYSIS AND INTERPRETATION

This chapter deals with the description of the study subjects, analysis and description of data collected to assess the effectiveness of Breastfeeding and Maternal holding on painful response in neonates undergoing heel lance. The findings were based on descriptive and inferential statistics and represented in figures, tables and text in this chapter. The findings are as follows:

SECTION A - Description of demographic variables of neonates in both groups SECTION B - Description of physiological parameters among both groups SECTION C - Description of painful scores among neonates in both groups SECTION D – Description of duration of cry according to their age in both groups SECTION E - Comparison of pain scores among neonates in both groups SECTION F – Comparison of neonate’s duration of cry according to their age in both groups SECTION G - Association of neonate’s demographic variables with pain score in both groups.

21

SECTION A DESCRIPTION OF DEMOGRAPHIC VARIABLES OF NEONATES IN BREASTFEEDING AND MATERNAL HOLDING GROUPS Table-1: Distribution of demographic variables (N= 80) Breastfeeding group Maternal holding group S.No Characteristics n = 40 n =40 Frequency (%) Frequency (%) Age 1. < 2 days 19 47.5 25 62.5 >2 days 21 52.5 15 37.5 Gestation 2. 36-38 weeks 22 55 26 65 38-40 weeks 18 45 14 35 Sex 18 45 23 57.5 3. Male 22 55 17 42.5 Female Birth weight 34 85 35 87.5 4. 2.5-3.5 kg 6 15 5 12.5 3.5- 4.5 kg Mode of delivery 13 32.5 19 47.5 5. Normal delivery 27 67.5 21 52.5 LSCS

Table 1, provides a summary of demographic characteristics of neonates in the breastfeeding and maternal holding groups. Based on the neonate’s age, it reveals that, 44 neonates (55%) belongs to < 2 days of age and 36 neonates (45%) belongs to > 2 days of age. According to their gestational age, 48 neonates (60%) were of 36- 38 weeks of gestation and 32 neonates (40%) were of 38-40 weeks of gestation. Regarding the sex of the neonates, out of 80 neonates, 41neonates (51.2%) were male and 39 neonates (48.8%) were female. According to the birth weight of the neonates, 69 neonates (86.3%) was between 2.5- 3.5kg. Most of the neonates 48 (60%) were delivered by LSCS.

22

47% 53% <2days >2days

Figure No: 2 Distribution of Neonates according to the Age in Breastfeeding group

38%

<2 days 62% >2 days

Figure No: 3 Distribution of Neonates according to the Age in Maternal Holding group

23

45% 55% 36-38 38-40

Figure No: 4 Distribution of Neonates according to the Gestation in Breastfeeding group

35%

36-38 65% 38-40

Figure No: 5 Distribution of Neonates according to the Gestation in Maternal Holding group

24

45% 55% male female

Figure No: 6 Distribution of Neonates according to the Sex in Breastfeeding group

43%

57% male female

Figure No: 7 Distribution of Neonates according to the Sex in Maternal Holding group

25

15%

2.5-3.5 kg 3.5-4 kg 85%

Figure No: 8 Distribution of Neonates according to the Birth weight in Breastfeeding group

13%

2.5-3.5 3.5-4

87%

Figure No: 9 Distribution of Neonates according to the Birth weight in Maternal Holding group

26

32%

normal 68% LSCS

Figure No: 10 Distribution of Neonates according to the Mode of delivery in Breastfeeding group

47% 53% normal LSCS

Figure No: 11 Distribution of Neonates according to the Mode of delivery in Maternal Holding group

27

SECTION B DESCRIPTION OF PHYSIOLOGICAL PARAMETERS AMONG BOTH GROUPS UNDERGOING HEEL LANCE

Table -2 Description of mean of physiological parameters of pain in both groups.

(N=80)

Mean SL Physiological Mean (post Groups S.D no. parameters (Baseline) heel lance) Breastfeeding 142.33 150.20 5.151 group 1. Heart rate Maternal holding group 141.93 160.3 5.361

Breastfeeding 98.40 95.43 1.317 group 2. Saturation Maternal holding group 99.13 91.55 1.448

The above table shows that the mean heart rate of the neonates in the breastfeeding and maternal holding groups before the heel lance were 142.33 and 141.93 respectively. The mean saturation of the neonates were 98.40 and 99.13 among breastfeeding and maternal holding groups before heel lance. After heel lance, the mean heart rate of the neonates in the breastfeeding group was 150.20 and that of maternal holding group was 160.3.The mean saturation of the neonates in the breastfeeding group was 99.53 and in maternal holding group it was 91.55 after heel lance.

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165

160

155

150

145

140

135

130

125

120

Baseline heart rate Post heel lance

Figure No.12. Distribution of Heart rate among the Breastfeeding group before and after heel lance.

180

170

160

150

140

130

120 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Baseline heart rate Post heel lance

Figure No.13. Distribution of Heart rate among Maternal holding group before and after the heel lance.

29

Baseline saturation Post heel lance

102

100

98

96

94

92

90

88 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Figure No. 14. Distribution of Saturation among the Breastfeeding group before and after heel lance.

Baseline saturation Post heel lance

105

100

95

90

85

80

75 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Figure No. 15. Distribution of Saturation among Maternal holding group before and after heel lance.

30

165

160 160.3

155 150.2 150

145 142.33 141.93

140

135

130 HEART RATE HEART RATE

Breastfeeding group Maternal holding group

Figure No.16. Description of mean heart rates in both groups before and after heel lance.

100

99.13 98 98.4

96

95.43 94

92 91.55 90

88

86 Saturation Saturation

Breastfeeding group Maternal holding group

Figure No. 17. Description of mean saturation in both groups before and after heel lance.

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SECTION C DESCRIPTION OF PAIN SCORES OF NEONATES IN BREASTFEEDING AND MATERNAL HOLDING GROUPS Table- 3 Description of pain scores in Breast feeding groups (N= 40) Breastfeeding Group Sl.No Demographic Variables Moderate Mild or No Pain Severe Pain Pain 1. Age < 2 days 18 1 0 > 2 days 19 2 2. Gestational age 36-38 weeks 21 1 0 38-40 weeks 16 2 3. Sex Male 18 0 0 Female 19 3 4. Birth weight 2.5-3.5 kg 31 3 0 3.5-4.5 kg 6 0 5. Mode of delivery Normal delivery 14 0 0 LSCS 23 3

The above table shows that the pain scores of the neonates in the breastfeeding group in relation with their demographic variables. While categorizing the age of the neonates 18 had mild pain and 1 neonate hade moderate pain in < 2 days of age and in >2 days of age, 19 had mild pain and 2 had moderate pain. In gestational age, 21 neonates had mild pain and one neonate had moderate pain in 36-38 weeks of gestation and 16 neonates had mild pain and rest two had moderate pain in 38-40 weeks of gestation. 18 male neonates had mild pain and 19 female neonates had mild pain and 3 of them had moderate pain. Neonates who belonged to 2.5 -3.5 kg 31 of them had mild pain and 3 had moderate pain and 6 had mild pain in neonates who had birth weight

32 ranging from3.5-4.5 kg. 14 neonates had mild pain who had normal delivery and in LSCS 23 had mild pain and 3 of them had moderate pain. Table-4 Description of pain scores in Maternal holding groups (N= 40) Maternal Holding Group Sl.no Demographic Variables Mild or No Moderate Severe Pain Pain Pain Age 7 18 1. < 2 days 0 1 14 > 2 days

Gestational age 4 22 2. 36-38 weeks 0 5 9 38-40 weeks

Sex 5 19 3. Male 0 4 12 Female

Birth weight 8 26 4. 2.5-3.5 kg 0 2 4 3.5-4.5 kg

Mode of delivery 6 14 5. Normal delivery 0 1 19 LSCS

The above table shows that the pain scores of the neonates in the maternal holding group in relation with their demographic variables. While categorizing the age of the neonates 7 had moderate pain and 18 neonate had severe pain in < 2 days of age and in >2 days of age, 1 had moderate pain and 14 had severe pain. In gestational age, 4 neonates had moderate pain and 22 neonate had severe pain in 36-38 weeks of gestation and 5 neonates had moderate pain and 9 had severe pain in 38-40 weeks of gestation. 8 male neonates had moderate pain and 26 had severe pain, 2 female neonates had moderate pain and 4 of them had moderate pain. Neonates who belonged to 2.5 - 3.5 kg 8 of them had moderate pain and 26 had moderate pain and 2 had moderate pain and 4 had severe pain in birth weight ranging from3.5-4.5 kg. 6 neonates had moderate pain, 14 had severe pain who had normal delivery and in LSCS 1had moderate pain and 19 had severe pain.

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Table 5- Description of level of pain among neonates

Breastfeeding Maternal holding Sl.no Category Frequency (%) Frequency (%) Mild or no pain 1 37 92.5 0 0 (less than 6) Moderate pain 2 3 7.5 9 22.5 (6-11) Severe pain 3 0 0 31 77.5 (more than 12)

The above table shows the description of pain level among neonates who underwent heel lance. In breastfeeding group 37 (92.5%) of the neonates had mild or no pain, 3 (7.5%) of them had moderate pain and in maternal holding group 9 (22.5%) of the neonates had moderate pain and 31 (77.5%) came under the category of severe pain.

40 37

35 31 30

25

20 Breastfeeding group 15 Maternal holding group

10 9

5 3 0 0 0 Mild or no pain Moderate pain Severe pain

Figure No. 18. Description of level of pain among neonate who underwent heel lance.

34

18

16

14

12

10

8

6

4

2

0 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940

Breastfeeding group Maternal holding group

Figure No.19. Distribution of pain scores of neonates in breastfeeding and maternal holding group

200 180 160 140 120 100 80 60

Duration of cry in seconds in cryof Duration 40 20 0 1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293031323334353637383940 Samples

Breastfeeding group Maternal holding group

Figure. No. 20 Description of duration of cry in Breastfeeding group and Maternal holding group

35

SECTION D DESCRIPTION OF DURATION OF CRY ACCORDING TO THEIR AGE IN BOTH GROUPS

Table 6 Description of duration of cry according to their age in Breastfeeding group

(N=40)

Breastfeeding Group Sl. No Age 30-50 10-30 seconds >50 seconds seconds 1. <2 days 11 6 2 2. >2 days 14 4 3

From the above table the duration of cry according to their age in breastfeeding group revealed that in < 2 days of age 11 neonates cried in range of 10-30 seconds, 6 in 30-60 seconds and 2 neonates in>50 seconds. In > 2 days of age 14 neonates cried in range of 10-30 seconds, 4 in 30-60 seconds and 3 neonates in>50 seconds.

Table 7 Description of duration of cry according to their age in Maternal holding group

(N=40)

Maternal holding Group Sl. No Age 60-80 80-100 >100 seconds seconds seconds 1. <2 days 3 5 17 2. >2 days 1 0 14

From the above table the duration of cry according to their age in breastfeeding group revealed that in < 2 days of age 3 neonates cried in range of 10-30 seconds, 5 in 30-60 seconds and 17 neonates in>50 seconds. In > 2 days of age 1 neonates cried in range of 10-30 seconds, 0 in 30-60 seconds and 14 neonates in>50 seconds.

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SECTION E

COMPARISON OF PAIN SCORES AMONG NEONATES UNDERGOING HEEL LANCE IN BREAST FEEDING AND MATERNAL HOLDING GROUP

Table-8 Comparison of pain scores of behavioral parameters among neonates undergoing heel lance in both group

(N= 80)

Behavioral Sl.No Groups Mean S.D ‘t’ Value parameters Breastfeeding 1.10 0.709 group 1. Behavioral state 6.605** Maternal holding 2.43 0.844 group Breastfeeding .35 0.533 group 2. Brow bulge 14.907** Maternal holding 2.10 0.496 group Breastfeeding .78 0.423 group 3. Eye squeeze 17.670** Maternal holding 2.62 0.490 group Breastfeeding .20 0.405 group 4. Nasolabial furrow 16.153** Maternal holding 1.88 0.404 group **P<0.01

From the above table, the‘t’ value for the behavioral state was 6.605 significant at p<0.01, brow bulge 14.907 significant at p<0.01, eye squeeze 17.670 significant at p<0.01 and Nasolabial furrow were 16.153 significant at p<0.01 respectively It indicates that there is a significant difference in the behavioral cues of neonates among the breastfeeding and maternal holding groups.

37

Table- 9 Comparison of pain scores of physiological parameters among neonates undergoing heel lance in both groups.

(N= 80)

Physiological Sl.no Groups Mean S.D ‘t’ value parameters

Breastfeeding group .90 .379

1. Heart rate Maternal 10.743** holding group 2.18 .594

Breastfeeding group .80 .464

2. Saturation 15.353** Maternal 2.35 .483 holding group

**P<0.01

From the above table, the computed‘t’ value for the heart rate and saturation are 10.743 significant at p<0.01 and 15.353 significant at p<0.01 respectively. It indicates that there exist a significant difference in the physiological cues of neonates among the breastfeeding and maternal holding groups.

38

3

2.5

2

1.5

mean scores mean 1

0.5

0

Behavioral state Brow bulge Eye squeeze Nasolabial furrow

Breastfeeding group Maternal holding group

Figure No.21. Comparison of mean scores of behavioral cues of pain among breastfeeding and maternal holding groups

2.5

2

1.5

1

mean scores mean 2.35 2.18 0.5 0.9 0.8

0 Heart rate Saturation

Breastfeeding group Maternal holding group

Figure No. 22. Comparison of mean scores of physiological cues of pain among breastfeeding and maternal holding groups

39

Table-10 Comparison of the mean pain scores among breast feeding and maternal holding groups

(N=80)

Group Mean S.D ‘t’ value Breastfeeding group 4.10 1.959 Maternal holding 27.136** 13.60 1.033 group **P<0.01

In the above table, the ‘t’ value for the pain score between the breastfeeding and maternal holding group is 27.136 which is greater than the table value and is significant at (P<0.01). It means that there exist a difference between the breastfeeding and maternal holding group in the pain score. The mean pain score of breastfeeding and maternal holding groups are 4.10 and 13.60 respectively. It indicates that babies in the breastfeeding group demonstrated less pain responses with breastfeeding than the children in the maternal holding group.

14

12 13.6 10

8

6 4.1 4

2

0

Breastfeeding group Maternal holding group

Figure No. 23. Comparison of mean pain scores among the breastfeeding and maternal holding group

40

SECTION F COMPARISON OF NEONATE’S DURATION OF CRY ACCORDING TO THEIR AGE IN BOTH GROUPS Table: 11 Comparison of neonate’s duration of cry according to their age in breastfeeding group (N = 40)

Mean Age SD “t” value (seconds) <2 days 31.79 13.903 .434

>2 days 31.38 13.775 (NS)

(NS- Non- Significant)

The above table shows the comparison of mean duration of cry in neonates according to their age in breastfeeding group. Neonates < 2 days had 31.79 mean duration of cry and > 2 days had 31.38 mean duration of cry. The computed paired value .434 was not significantly at p<0.01 levels. This establish that there is no significant difference between the duration of cry and age in breastfeeding group

Table: 12 Comparison of neonate’s duration of cry according to their age in maternal holding group

(N = 40)

Mean Age SD “t” value (seconds) <2 days 124.08 30.245 4.093** >2 days 139.07 24.671

** p<0.01

The above table shows the comparison of mean duration of cry in neonates according to their age in maternal holding group. Neonates < 2 days had 124.08 mean duration of cry and > 2 days had 139.07 mean duration of cry. The computed paired value 4.093 was significant at p<0.0levels. This establish that there is a significant difference between the duration of cry and age in maternal holding group.

41

SECTION G

ASSOCIATION BETWEEN THE NEONATES DEMOGRAPHIC VARIABLES AND THEPAIN SCORES IN BOTH GROUPS

Table -13 Association between the neonates’ demographic variables and the pain scores in breastfeeding

(N=40)

S.N Characteristics Frequency df Chi- square

Age 0.10 1. <2 days 19 1 (NS) >2 days 21 Gestation 0.40 2 36-38 weeks 22 1 (NS) 38-40 weeks 18

Sex 0.40 3 Male 18 1 (NS) Female 22

Birth weight 16.92* 4 2.5-3.5 kg 34 1

3.5-4.5 kg 6

Mode of delivery 4.90* 5 Normal delivery 13 1

LSCS 27

* P<0.05, NS- Non significant

Above table shows the association between the neonates’ demographic variables and the pain scores in breast feeding. The chi- square value for birth weight in breastfeeding group is 16.92 and mode of delivery is 4.90 which indicates significance at p<0.05 level. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight and mode of delivery.

42

Table-14 Association between the neonates’ demographic variables and the pain scores in maternal holding

(N=40)

S.N Characteristics Frequency df Chi- square

Age 1 2.500 1. <2 days 25 (NS) >2 days 15 Gestation 3.600 2 36-38 weeks 26 1 (NS) 38-40 weeks 14

Sex 0.900 3 Male 23 1 (NS) Female 17

Birth weight 22.5* 4 2.5-3.5 kg 35 1

3.5-4.5 kg 5

Mode of delivery 0.752 5 Normal delivery 19 1 (NS) LSCS 21

* P<0.05, NS- Non significant

Above table shows the association between the neonates’ demographic variables and the pain scores in maternal holding. The chi- square value for birth weight in maternal holding group is 22.5 which is significant at p<0.05 level. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight.

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CHAPTER V

DISCUSSION, SUMMARY, CONCLUSION, IMPLICATIONS,

LIMITATIONS AND RECOMMENDATIONS

This chapter deals with the discussion, summary and conclusion. It also clarifies the limitation of the study, implication and recommendations given for the different areas of nursing practice, nursing education, nursing administration and nursing research. In this study the researcher made an attempt to identify the effectiveness of breastfeeding and maternal holding during heel lance among neonates.

Pain is a complex biological, psychological, and social phenomenon. Given this complexity, the subjective individual nature of pain and the infants’ inability to provide self-report, a comprehensive measurement approach combining reliable and valid indicators is required. Pain assessment is the cornerstone of effective management of pain and vital in pediatric care.

Breast-feeding or breast milk feeding involves the presence of a person who cares for the baby. It involves holding the baby closely, which helps in moderating the painful experience. There is also skin-to-skin contact with the caregiver and, additionally, breast milk contains agents that have analgesic properties or can be endogenously converted into analgesic substances. Breast-feeding or breast milk feeding is a natural way to achieve analgesia and, unlike sucrose, does not have any adverse effect on successful breast-feeding. Maternal holding is also a non- pharmacological technique to reduce procedural pain and comfort in irritable babies.

DISCUSSION

The present study was to assess the effectiveness of breastfeeding and maternal holding during heel lance among neonates. The data collected were analyzed statistically and represented as tables and graphs in the previous chapter. The formulated hypothesis is statistically proved and set objectives were achieved.

 Assess the painful responses among neonates in both groups undergoing heel lance procedure. Description of the demographic variables in both groups

44

In the present study, the demographic characteristics of the neonates in breastfeeding group were assessed. Based on their age, 48 percentage belongs to < 2 days and 53 percentage belongs to > 2 days. 55 percentage of neonates belongs 36- 38 weeks of gestation and 45 percentage of neonates belongs to 38-40 weeks of gestation.45 percentage of male and 55 percentage of female neonates were categorized under the sex. While categorizing the birth weight 85 percentage of neonates belongs under 2.5- 3.5 kg and 15 percentage of neonates belongs under 3.5- 4 kg. Most of the neonates i.e. 68 percentage underwent LSCS, and 33 percentage undergone normal delivery.

Demographic characteristics of the neonates in maternal holding group includes, based on their age 63 percentage belongs to < 2 days and 38 percentage belongs to > 2 days.65 percentage of neonates belongs 36- 38 weeks of gestation and 35 percentage of neonates belongs to 38-40 weeks of gestation. 58 percentage of male and 43 percentage of female neonates were categorized under the sex. While categorizing the birth weight 88 percentage of neonates belongs under 2.5-3.5 kg and 13 percentage of neonates belongs under 3.5- 4 kg. Most of the neonates i.e. 53 percentage underwent LSCS, and 48 percentage undergone normal delivery.

Description of mean physiological cues in both groups Here, the mean heart rate of the neonates in the breastfeeding before the heel lance were 142.33 and in maternal holding groups were 141.93 respectively. The mean saturation of the neonates in breastfeeding before heel lance were 98.40 and among maternal holding groups were 99.13. After heel lance, the mean heart rate of the neonates in the breastfeeding group was 150.20 and that of maternal holding group was 160.3.The mean saturation of the neonates in the breastfeeding group was 99.53 and in maternal holding group it was 91.55 after heel lance. Description of pain responses in both groups

The pain responses of the neonates in the breastfeeding group was done in relation with their demographic variables. While categorizing the age of the neonates 18 had mild pain and 1 neonate hade moderate pain in < 2 days of age and in >2 days of age, 19 had mild pain and 2 had moderate pain. In gestational age, 21 neonates had mild pain and one neonate had moderate pain in 36-38 weeks of gestation and 16 neonates had mild pain and rest two had moderate pain in 38-40 weeks of gestation. 18 male neonates had mild pain and 19 female neonates had mild pain and 3 of them had moderate pain.

45

Neonates who belonged to 2.5 -3.5 kg 31 of them had mild pain and 3 had moderate pain and 6 had mild pain in neonates who had birth weight ranging from3.5-4.5 kg. 14 neonates had mild pain who had normal delivery and in LSCS 23 had mild pain and 3 of them had moderate pain. The pain responses of the neonates in the maternal holding group was also done in relation with their demographic variables. While categorizing the age of the neonates 7 had moderate pain and 18 neonate had severe pain in < 2 days of age and in >2 days of age, 1 had moderate pain and 14 had severe pain. In gestational age, 4 neonates had moderate pain and 22 neonate had severe pain in 36-38 weeks of gestation and 5 neonates had moderate pain and 9 had severe pain in 38-40 weeks of gestation. 8 male neonates had moderate pain and 26 had severe pain, 2 female neonates had moderate pain and 4 of them had moderate pain. Neonates who belonged to 2.5 -3.5 kg 8 of them had moderate pain and 26 had moderate pain and 2 had moderate pain and 4 had severe pain in birth weight ranging from3.5-4.5 kg. 6 neonates had moderate pain, 14 had severe pain who had normal delivery and in LSCS 1had moderate pain and 19 had severe pain. Description of pain level among neonates undergoing heel lance in both groups The description of pain level among neonates who underwent heel lance. In breastfeeding group 37 (92.5%) of the neonates had mild or no pain, 3 (7.5%) of them had moderate pain and in maternal holding group 9 (22.5%) of the neonates had moderate pain and 31 (77.5%) came under the category of severe pain.

Compare the pain scores among Neonates with Breastfeeding and Maternal Holding.

Comparison of pain scores of behavioral cues among neonates undergoing heel lance in both group The present study indicates that there was a significant difference in the behavioral cues and physiological cues of neonates among the breastfeeding and maternal holding groups. The‘t’ value for the behavioral state was 6.605, brow bulge 14.907, eye squeeze 17.670 and Nasolabial furrow were 16.153 which is significant at p<0.01 and the‘t’ value for the heart rate and saturation are 10.743 and 15.353 respectively which is significant at p<0.01.

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Comparison of the mean pain scores among breast feeding and maternal holding group. . Hala, Mona, (2015) conducted a randomized clinical trial with 128 full term neonates to determine the efficacy of breast-feeding with maternal holding as compared with maternal holding without breastfeeding in relieving painful responses during heel lance. Independent t test showed significant differences in Premature Infant Pain Profile scale scores among the 2 groups (t =−8.447, P = .000) which was substantial with the present study. The‘t’ value for the pain score between the breastfeeding and maternal holding group was 27.136 which is greater than the table value and is significant at (P<0.01). It means that there exist a difference between the breastfeeding and maternal holding group in the pain score. The mean pain score of breastfeeding and maternal holding groups are 4.10 and 13.60 respectively. It indicates that babies in the breastfeeding group demonstrated less pain responses with breastfeeding than the children in the maternal holding group.  Comparison of neonate’s duration of cry according to their age in breastfeeding and maternal holding group

While comparing the neonates mean duration of cry according to their age, the neonates < 2 days had 31.79 and > 2 days had 31.38 respectively. The computed paired value .434 was not significantly at p<0.01 levels. This established that there is no significant difference between the duration of cry and age in breastfeeding group. Whereas in maternal holding group, neonates < 2 days had 124.08 mean duration of cry and > 2 days had 139.07 mean duration of cry. The computed paired value 4.093 was significant at p<0.01levels. This established that there is a significant difference between the duration of cry and age in maternal holding group.

 Association between the neonates’ demographic variables and the pain scores in breastfeeding The association between the neonates’ demographic variables and the pain scores in breast feeding. The chi- square value for birth weight in breastfeeding group is 16.92 and mode of delivery is 4.90 which indicates significance. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight and mode of delivery.

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 Association between the neonates’ demographic variables and the pain scores in maternal holding The association between the neonates’ demographic variables and the pain scores in maternal holding. The chi- square value for birth weight in maternal holding group is 22.5 which is significant. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight.

The present study revealed the findings that the neonates who were breastfed experienced less pain when comparing to maternal holding. Breast feeding was found to be an effective method in relieving the procedural pain among neonates.it is the simple, cost effective, comfortable and harmless intervention to help neonates to deal with procedural pain.

SUMMARY

The study was undertaken to compare the effectiveness of Breastfeeding and Maternal holding on painful responses among Term Neonates undergoing heel lance for Newborn screening. Breastfeeding and maternal holding was considered as the independent variable and behavioral and physiological responses of pain among neonates undergoing heel lance were considered as the dependent variables.

The objectives of the study were:

 Assess the painful responses among Neonates undergoing heel lance.

 Compare the pain scores among Neonates with breastfeeding and maternal holding.

 Associate the Neonate’s demographic variables with the level of pain who were on breast feeding during heel lance.

 Associate the Neonate’s demographic variables with their level of pain who were on maternal holding during heel lance.

The study tested the hypothesis that there is a significant difference in the pain response of Neonates on Breastfeeding than the Neonates on Maternal holding during heel lance. The study was based on modified Melzack and Wall’s Gate Control theory. Randomized Control Trial post- test only design was adopted for the study. The

48 population was comprised of 80 neonates (40 in each group) from birth to 28 days who are subjected to heel lance procedure. The samples were selected using Simple random sampling technique by Block random method. The tool adopted for the data collection by the researcher was Premature Infant Pain Profile (PIPP) which was developed by Stevens Johnston et.al in 1996. The tool was found to be valid and reliable through pilot study.

The data was collected for a given period of 6 weeks at KMCH. The subjects in the Group1 received Breastfeeding and Group2 received Maternal Holding.

Based on the objectives and hypothesis, data were analyzed by using descriptive and inferential statistics to document the effectiveness of breastfeeding and maternal holding on pain among neonates. Independent‘t’ test was used to test the hypothesis in the study.

MAJOR FINDINGS OF THE STUDY

 The samples in the study based on their age, reveals that, 44 neonates (55%) belongs to < 2 days and 36 neonates (45%) belongs to > 2 days in breastfeeding and maternal holding group.  While grouping the neonates according to their gestational age, 48 neonates (60%) were of 36- 38 weeks of gestation and 32 neonates (40%) were of 38-40 weeks of gestation.  Relating the sex of the neonates, out of 80 neonates, 41neonates (51.2%) were male and 39 neonates (48.8%) were female.  Considering the birth weight of the neonates, 69 neonates (86.3%) were between 2.5- 3.5kg and 11 neonates (13.8%) were between 3.5- 4.5 kg.  Most of the neonates 48 (60%) were delivered by LSCS and 32 (40%) neonates delivered normally.  The mean heart rate of neonates in breastfeeding group was 150.20 and that of the maternal holding group was 160.3. The mean saturation in the breastfeeding group was 99.53 and maternal holding group had 91.55.  The neonates mean duration of cry according to their age, the neonates < 2 days had 31.79 and > 2 days had 31.38 respectively. The computed paired value .434 was not significantly at p<0.01 levels. This established that there is no

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significant difference between the duration of cry and age in breastfeeding group.  In maternal holding group, neonates < 2 days had 124.08 mean duration of cry and > 2 days had 139.07 mean duration of cry. The computed paired value 4.093 was significant at p<0.01levels. This established that there is a significant difference between the duration of cry and age in maternal holding group.  There was a significant difference in the behavioral and physiological cues of pain among the both groups. The computed‘t’ value for behavioral cues were as follows: for behavioral state 6.605 which is significant at level of p<0.01, brow bulge 14.907 which is significant at level of p<0.01, eye squeeze 17.670 which is significant at level of p<0.01 and nasolabial furrow was 16.153 which is significant at level of p<0.01. The‘t’ value for physiological cues were 10.743 and 15.353 respectively.  While assessing the level of pain among neonates who underwent heel lance, in breastfeeding group 37 (92.5%) of the neonates had mild or no pain, 3 (7.5%) of them had moderate pain and in maternal holding group 9 (22.5%) of the neonates had moderate pain and 31 (77.5%) came under the category of severe pain.  The mean pain score of breastfeeding and maternal holding groups were 4.10 and 13.60 respectively with a computed‘t’ value of 27.136 which is significant at level of p<0.01. Babies who received breast feeding as an intervention showed less pain response during heel lance. It shows that there is a significant difference between the two groups and thus alternative hypothesis was accepted.  The computed paired value 4.093 was significant at p<0.01 levels while comparing the duration of cry according to their age. This establish that there is a significant difference between the duration of cry and age in maternal holding group.  The chi- square value for birth weight in breastfeeding group is 16.92 and mode of delivery is 4.90 which indicates significance. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight and mode of delivery.

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 The chi- square value for birth weight in maternal holding group is 22.5 which is significant. It shows there is no association between the neonates’ demographic variables and the pain scores except birth weight.

CONCLUSION

 Breastfeeding is an effective technique in reducing the procedural pain among neonates.  Neonates in the Breast feeding group had only mild pain while heel lance.  Behavioral cues showed that the neonates had less pain in breastfeeding group comparing the maternal holding group.  Physiological cues showed a remarkable increase in the heart rate and decreased saturation in the maternal holding group comparing breastfeeding group.  Breastfeeding group neonates cried less than one minute  Maternal holding neonates cried more than 2 minutes.  Birth weight and mode of delivery in breastfeeding group showed a significant relation with the neonates’ pain scores.  In maternal holding group, birth weight showed a significant relation with the neonates’ pain scores.

IMPLICATIONS Pediatric nurses caring neonates in the pediatric wards and postnatal wards can select and implement non pharmacologic strategies for pain management during diagnostic and therapeutic procedures. An effective, easy to implement and a practical intervention breastfeeding appears to be highly effective in reducing procedural pain in neonates. The findings of the study have several implications in nursing practice, nursing education, nursing administration and nursing research.

Nursing Practice The findings of the study clearly highlights the distress of the babies undergoing heel lance and alert the nurses for effective pain management strategies. The implication of nursing practice from the present study as follows:  The study helps the nurses to gain knowledge regarding the need for the effective pain management among neonates.

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 The study helps the nurses to gain adequate knowledge and skill in assessing neonatal pain and documentation.  Nurses can use different non pharmacological pain management measures as to practice independently.  Effective pain management and providing comfort is the fundamental responsibility of a pediatric nurse. So breastfeeding can be used for routine painful procedures in pediatric and postnatal wards. Nursing education  The study helps to provide knowledge in assessing and documenting neonatal response to pain.  Nurse educator can teach nurses and mothers regarding the different non pharmacological strategies for pain management. Nursing research  The findings of this study can be utilized by future researchers  The findings of the study can be disseminated as to utilize non pharmacological strategies for future research.  As painful procedures are common in pediatric and postnatal wards emphasize must be given to non-pharmacological pain management strategies.  The nurses get motivated to conduct a research on introduction of innovative methods of pain management strategies during painful procedures. Nursing administration  The nurse administrator prepares the clinical manual comprising tools and medical record audit forms regarding various non-pharmacological pain management strategies.  The study information can be utilized by the administrator to convince the nurses regarding the need for effective pain management and this will help in improving patient care.  The administrator must create a conducive environment to practice the strategies effectively in wards.  Organize in service education programmes for nurses to train and motivate the use of non -pharmacological pain management measures during their practice.

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LIMITATIONS  Duration of the pain could not be assessed.  The aftereffect of pain could not be assessed.  The use of the PIPP scale for pain assessment may also be considered as a limitation of the study because pain is based on self-report.

RECOMMENDATIONS  A similar study can be done with a large samples to generalize the results.  A descriptive study can be conducted to assess the nurse’s use of non - pharmacological pain management measures during painful procedures.  A single intervention can be selected for assessing the effectiveness during painful procedures.  A similar study can be conducted during other painful procedure

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ABSTRACT

Study entitled “A comparative study to assess the effectiveness of Breastfeeding and Maternal holding on painful responses among Term Neonates undergoing heel lance for Newborn screening at KMCH, Coimbatore”. Objectives: the main aim of the study was to assess the pain responses among neonates, compare the pain scores among Neonates with Breastfeeding and Maternal holding group and to associate pain scores with demographic variables in both groups. Design: Randomized Control Trial post- test only design. Setting: Kovai Medical Center and Hospital, Coimbatore. Sample size: 80 Neonates, 40 in Breastfeeding group and Maternal holding group from birth to 28 days who fulfill the criteria in the study. Conceptual framework: Modified Gate Control Theory by Melzack and Wall (2012). Data collection procedure: After obtaining ethical clearance from concerned authorities, demographic data was collected from records. The investigator assessed the baseline heart rate and saturation of the neonates before procedure for 15 seconds and measured the variation in the heart rate and saturation and duration of cry by observing the pulse oxymeter which is attached to the neonates during heel lance for 30 seconds. Same way the neonates in control group were mummified and held in their mothers arm with heel exposed during the procedure and the investigator measured the variation in the heart rate and saturation and duration of cry by observing the pulse oxymeter during heel lance. In both group the pain were measured by using the PIPP scale. Results: The mean pain score of breastfeeding and maternal holding groups were 4.10 and 13.60 respectively with a computed‘t’ value of 27.136 which is significant at level of p<0.01. Babies who received breast feeding as an intervention showed less pain response during heel lance. It shows that there is a significant difference between the two groups and thus alternative hypothesis was accepted. Breastfeeding group neonates cried less than one minutes and Maternal holding neonates cried more than 2 minutes. Conclusion: The intervention received by the neonates in breastfeeding group showed less mean pain score compared to maternal holding. So breastfeeding is an effective technique in reducing the procedural pain among neonates.

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injections: A clinical randomized trial: BMC Anesthesiol BMC Anesthesiology, 13(1) 22. http://www.ncbi.nlm.nih.gov/pubmed/24028182 35. Modares. M, Vasegh Rahim Parvar S.F, (2007), Effects of breastfeeding on pain relief in full term Newborn: Journal of Pediatrics, 25, 827, - 832. http://link.springer.com/article/10.1186/1471-2253-13- 22/fulltext.html?view=classic 36. Nimbalkar, S. M., Chaudhary, N. S., 2013. Kangaroo mother care in reducing pain in preterm neonates on heel prick: The Indian journal of pediatrics, 80(1), 6-16. http://www.ncbi.nlm.nih.gov/pubmed/22544676 37. Obeidat, H. M., & Shuriquie, M. A. (2015). Effect of Breast-Feeding and Maternal Holding in Relieving Painful Responses in Full-Term Neonates. The Journal of Perinatal & Neonatal Nursing, 29(3), 248-254. http://www.ncbi.nlm.nih.gov/pubmed/26218818 38. Osinaike, B. B., Oyedeji, A. O., Adeoye, O. T., Dairo, M. D., & Aderinto, D. A. (2007). Effect of breastfeeding during venipuncture in neonates: Annals of Tropical Pediatrics, 27(3), 201-205. https://www.researchgate.net/publication/6124456 39. Prakash S, Lucia, Vibuti Shah. Breastfeeding to alleviate procedural pain in neonates. Breastfeeding medicine.2007; 2(2):74-82 https://www.researchgate.net/publication/6176739 40. Razek, A. A., & El-Dein, N. A. (2009). Effect of breast-feeding on pain relief during infant immunization injections. International Journal of Nursing Practice, 15(2), 99-104. http://www.ncbi.nlm.nih.gov/pubmed/19335527 41. Riddell, R. P., Racine, N., Turcotte, K., Uman, .L. S., Horton, R., Osmun, L. D., Lisi, D. (2012). Non-pharmacological Management of Procedural Pain in Infants and Young Children: An Abridged Cochrane Review. Pain Research and Management, 16(5), 321-330. http://www.ncbi.nlm.nih.gov/pubmed/22059204 42. Saeidi, R., Asnashari, Z., Armurnejad, M., et.al. 2011. Use of kangaroo care to alleviate the intensity of vaccination pain: Iranian journal of pediatrics, 21(1), 99-102 http://www.ncbi.nlm.nih.gov/pubmed/23056772

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43. Shah, P. S., Aliwalas, L. L., & Shah, V. S. (2006). Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews. www.ncbi.nlm.nih.gov/pubmed/16856069,15266438 44. Shah, P. S., Herbozo, C., Aliwalas, L. L., & Shah, V. S. (2012). Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews. https://www.nichd.nih.gov/cochrane 45. Stevens, B., Johnston, C., Petryshen, P., & Taddio, A. (1996). Premature Infant Pain Profile: Development and Initial Validation. The Clinical Journal of Pain, 12(1), 13-22. http://www.ncbi.nlm.nih.gov/pubmed/8722730 46. Stevens, B., Johnston, C., Taddio, A., Gibbins, S., & Yamada, J. (2010). The Premature Infant Pain Profile: Evaluation 13 Years after Development. The Clinical Journal of Pain, 26(9), 813-830. http://www.ncbi.nlm.nih.gov/pubmed/20717010 47. Susan, M., Robert, B., 2005. Skin to skin contact analgesia for preterm infants: AACN clinical issues. 16(3). 373-387. http://www.ncbi.nlm.nih.gov/pubmed/16082239/ 48. Uga, E., Candriella, M., Perino, A., Alloni, V., Angilella, G., Trada, M., Provera, S. (2008). Heel lance in newborn during breastfeeding: An evaluation of analgesic effect of this procedure. Italian Journal of Pediatrics, 34(1), 3. http://www.ncbi.nlm.nih.gov/pubmed/19490654 49. Weissman, A., Aranovitch, M., Blazer. S., Zimmer, E. L., (2009). Heel lancing in newborns: behavioral and spectral analysis assessment of pain control methods: Journal of pediatrics. 124(5). 921-6. http://www.ncbi.nlm.nih.gov/pubmed/19841119 ONLINE REFERENCE 50. International association for the study of pain-IASP. (2012). “Newborns and premature babies feel pain”. http://www.iasp.org. 51. Kate. M. (1999) “Infant pain may have long term effects”. Retrieved from http://www.scienceagogo.com/news. 52. Kendrick. A., Twomey. B., (2016), Clinical guidelines on neonatal pain assessment. http://www.rch.org.

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UNPUBLISHED THESIS

53. Dhanya, “A study to assess the effectiveness of positive touch on mother – infant bonding and behavior cues among high risk newborns admitted in NICU at KMCH, Coimbatore”. Dr. M. G. R. Medical University, 2012. 54. Shiny, K. J., “Effectiveness of swaddling on pain among neonates undergoing heel lance at NICU in KMCH, Coimbatore”. Dr. M. G. R. Medical University, 2012.

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APPENDIX-I

Sample no:

1. Age of the baby…………………………… days

2. Gestation age of the baby…………………

3. Sex

i. Male

ii. Female

4. Birth weight

i. 2500 – 3500 gm

ii. 3500- 4500gm

5. Mode of delivery

i. Normal delivery

ii. LSCS

APPENDIX-II

Premature Infant Pain Profile

Indicator Finding Scores

0 >= 36 weeks

1 32 weeks to 35 weeks 6 days

Gestational age 2

28 weeks to 31 weeks 6 days

3 < 28 weeks

0 active/awake eyes open facial movements

1 Behavioral state quiet/awake eyes open no facial movements

2 active/sleep eyes closed facial movements

3 quiet/sleep eyes closed no facial movements

0 0-4 beats per minute increase

Heart rate maximum 5-14 beats per minute increase 1

15-24 beats per minute increase 2

>= 25 beats per minute increase 3

0 to 2.4% decrease 0

2.5 to 4.9% decrease 1 Oxygen saturation minimum 5.0 to 7.4% decrease 2

7.5 % decrease or more 3

None (<=9% of time) 0

Minimum (10 – 39% of time) 1 Brow bulge Moderate (40 – 69% of time) 2

Maximum (>= 70% of time) 3

0 None (<=9% of time)

Eye squeeze Minimum (10 – 39% of time) 1

Moderate (40 – 69% of time) 2

Maximum (>= 70% of time) 3

None (<=9% of time) 0

Minimum (10 – 39% of time) 1 Nasolabial furrow Moderate (40 – 69% of time) 2

Maximum (>= 70% of time) 3

APPENDIX-III

Observational Performa for assessing Duration of cry in Neonates

Duration of cry (in seconds) S. No. Age Breastfeeding group Maternal holding group

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20. APPENDIX-IV COPY OF PERMISSION LETTER TO CONDUCT THE STUDY

APPENDIX-V

COPY OF ETHICAL CLEARANCE LETTER TO CONDUCT STUDY APPENDIX-VI COPY OF CERTIFICATION FOR CONTENT VALIDITY COPY OF CERTIFICATION FOR CONTENT VALIDITY

COPY OF CERTIFICATION FOR CONTENT VALIDITY

APPENDIX-VII LIST OF EXPERTS 1. Dr. A. R Srinivas, M.D. (Paed), FRACP in Neonatology- Australia Consultant Neonatologist Kovai Medical Center and Hospital, Coimbatore- 14 2. Dr. K. Rajendran, M.B.B.S., M.D Consultant Neonatologist and Pediatrician Kovai Medical Center and Hospital, Coimbatore- 14 3. Dr. R. Balakrishnan M.D. (Paed) DCH (Sydney), Neonatal Fellow (Australia). Consultant Neonatologist (Newborn Care) Kovai Medical Center and Hospital, Coimbatore- 14 4. Mrs. N. B. Mahalakshmi Professor Dept. of Pediatric Nursing KMCH College of Nursing Coimbatore- 14 5. Mrs. R. Sasikala Associate Professor Dept. of Pediatric Nursing KMCH College of Nursing Coimbatore- 14 6. Mrs. Alice Rani Assistant Professor Dept. of Pediatric Nursing KMCH College of Nursing Coimbatore- 14