Review Pain Management For Neonates Health And Social Care Essay

Review of literature is defined as a critical summary of review on a topic of interest, often prepared to put a research problem in contest (Polit & Beck,2006). The review of literature in the research report is a summary of current knowledge about a particular practice problem and includes what is known and not known about the problem. The literature is reviewed to summarize knowledge for use in practices or to provide a basis for conducting a study (Burns, 1997).

This study examined the effects of Expressed Breast Milk (EBM) on behavioural response related to venepuncture in neonates. From the collected review of various associated literature and research studies, topics can be divided as follow;

Section A: Studies related to pain perception of neonates.

Section B: Studies related to non pharmacological pain management for neonates.

Section C: Studies related to expressed breast milk on pain management.

Section D: Studies related to using breast milk in other conditions.

Section A: Studies Related To Pain Perception of Neonates.

Brenda Clain & Zeev Kain (2005) stated in a study which was conducted in a tertiary neonatal intensive care unit to assess the need for improved pain relief measures for neonates. The neurotransmitters and structures required for pain sensation as well as structures needed for long-term memory are developed adequately in the neonate and thus have the potential to affect long-term outcomes. The study indicated that the number of procedures to which each infant was exposed ranged from 0 to 53 per day. On a scale of 0 to 10, the average pain score in these infants ranged from 1.7 for a diaper change to 8.9 for endotracheal intubation. The investigators indicated also that approximately 40% of all neonates did not receive any analgesia at all during the intensive care stay. These findings point to the continuous need to educate the medical community regarding the long-term outcomes of pain management in neonates. In conclusion, the current research in neonatal pain makes it clear that aggressive pain control in the neonate is desirable not only for the management of current pain but also for protection from pain experiences to come.

Ann Victoria Myron, Denise Poirier Maguire & Jane Corrigan wandel (2004) conducted a study on pain perception in the neonate at Boston’s Beth Isreal Hospital. Routine neonatal circumcision is still performed in most centers without the benefit of anesthesia. Newborns were frequently not given analgesic or anesthetic agents during invasive procedures, including surgery. The researcher concluded that the neuro chemical systems now known to be associated with pain transmission and modulation are intact and functioning in newborns. Moreover, although it is unclear that a neonate subjectively experiences pain in a manner similar to older children and adults, there is evidence of “physiologic and perhaps even a psychological form of stress in premature or full-term neonates” in response to painful stimuli.

Dodds (2003) conducted a survey on neonatal procedural pain among nursing staff in children’s hospital research centre, USA. A total of twenty one neonatal nursing staff were selected and administered a self completion questionnaire to investigate about attitude towards neonatal pain assessment, pharmacological and non pharmacological management of pain. The result showed that 48% of nurses using pain assessment tool and for pharmacological management 66% of nurses using non-nutritive sucking for pain management but other non pharmacological methods are rarely used.

Ivy Rouzan (2001) did an analysis of research and clinical practice in neonatal pain management. The purpose of the trial was to review the literature on neonatal pain management with a focus on historical misconceptions, ethical issues, barriers to practice, the role of the advanced practice nurse. Health care professionals agree that neonates experience pain and in turn deserve effective treatment. Research is controversial regarding the extent of pain management necessary in relation to short-term benefits and long-term consequences. Ethical issues arise when research supporting pain management is not consistently utilized in nursing practice.

Section B: Studies Related To Non-Pharmacological Pain Management For Neonates.

Brenda Golianu et al (2007) conducted a study on efficacy of non-pharmacological therapies for neonatal pain management. A number of non pharmacological therapies have been investigated, including nonnutritive sucking with and without sucrose use, swaddling or facilitated tucking, kangaroo care, music therapy, and multi-sensorial stimulation. The researcher concluded that even though the efficacy of these approaches is clearly evident, they cannot provide analgesia for moderate or severe pain in the neonate, non-pharmacological therapies can be used for minor pain management in neonates.

Cignacco et al (2007) reviewed thirteen randomized controlled trials to identify the efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A literature search was conducted via the MedLine, CINAHL, Cochrane Library databases and complemented by a hand search. The literature search covered the period from 1984 to 2004. Data were extracted according to pre-defined criteria by two independent reviewers and methodological quality was assessed. The selected interventions were “non-nutritive sucking”, “music”, “swaddling”, “positioning”, “olfactory and multisensorial stimulation”, “kangaroo care” and “maternal touch”. The researcher concluded that some of the non-pharmacological interventions such as “non-nutritive sucking”, “swaddling” and “facilitated tucking” had shown favourable effect on pulse rate, respiration, oxygen saturation, reduction of motor activity, and on excitation states after invasive measures.

A study was conducted by Eunsook Park (2007) on pain reduction of heel stick procedure among ninety-nine healthy neonates. The purpose of this study was to find the effect of Yakson (i.e. a traditional Korean touching method) and non-nutritive sucking (NNS) on reducing the pain that neonates experience when undergoing the heel stick procedure for blood testing. The study samples were assigned into three groups: group I Yakson (n = 33), group II NNS (n = 33), and group III control group (n = 33). Intervention was provided to the Yakson and NNS groups one minute prior to heel stick till the completion of the heel stick. For the Yakson group, a researcher caressed the belly of a neonate with one hand while supporting the back with the other hand. For the NNS group, a pacifier packed with sterile gauze was put in the neonate’s mouth. The oxygen saturation levels in the Yakson and NNS group neonates were maintained significantly better than in the control group neonates. There was no significant difference between the groups with regard to heart rate and neonatal infant pain, which was measured using Neonatal Infant Pain Scale. Findings indicated that Yakson can be used during heel stick to help neonates to maintain their oxygen saturation level following the heel stick procedure.

A prospective trial was performed by Karen Corff (2006) to identify the effectiveness of facilitated tucking, a non-pharmacologic nursing intervention, as a comfort measure in modulating preterm neonates’ physiologic and behavioral responses to minor pain among thirty preterm neonates belonging to the age group of 25-35 weeks of gestation at Edmond. The objective of the study was that premature neonates will have less variation in heart rate, hemoglobin, oxygen saturation, shorter crying, sleep disruption times, and less fluctuation in sleep states in response to the painful stimulus of a heel-stick with facilitated tucking than without facilitated tucking. In this study, heart rate, oxygen saturation, and sleep state were recorded 12 minutes before, during, and 15 minutes after two heel-sticks, one with and one without facilitated tucking. Neonates demonstrated a lower mean heart rate six to ten minutes post-stick (p < 0.04), shorter mean crying time (p < 0.001), shorter mean sleep disruption time (p < 0.001), and fewer sleep-state changes (p = 0.003) after heel-stick with facilitated tucking than without facilitated tucking. The study had shown that facilitated tucking was an effective comfort measure in attenuating premature neonates psychologic and behavioral responses to minor pain.

Yajai Sitthimongkol et al (2005) did a meta-analysis of the effectiveness of non-pharmacological pain management in reducing pain from heel stick blood sampling in newborns. A number of non-pharmacological pain management interventions which includes swaddling , positioning, holding and rocking, nonnutritive sucking, breast milk or breast feeding, and oral sucrose had been used to reduce pain from heel stick in preterm and full term neonates. The researcher concluded that preterm neonates who were arranged in a side-lying or supine position with flexed arms and legs close to the infant’s trunk demonstrated a lower mean heart rate, a shorter mean crying time, a shorter mean sleep disruption time, and fewer sleep-state changes after the heel stick procedure.

Carbajal (2004) investigated the effectiveness of oral sucrose in alleviating procedural pain. The hypothesis of this study was that non-pharmacological interventions can reduce neonatal pain indirectly by reducing the total amount of noxious stimuli to which infants are exposed directly, by blocking nociceptive transduction or transmission or activation of descending inhibitory pathways or by activating attention and arousal systems that modulate pain. The researcher administered one to two milliliter of oral sucrose or 30% glucose at two minutes before a minor painful procedure in term neonates or neonates weighing more than 2500 gm. For preterm neonates weighing less than 2500gm, 0.5 ml of oral sucrose or 30% glucose and for those weighing less than 1500gm, 0.3 ml of oral sucrose or 30%glucose was administered. The researcher concluded that when newborns were given pacifier with sweet solutions had synergistic effect in alleviating minor procedural pain.

Section C: Studies Related To Expressed Breast Milk On Pain Management In Neonates.

Elodie Zana (2009) conducted a randomized controlled study on analgesic effect of breast milk for procedural pain among forty two preterm infants. The hypothesis of this study was that breast milk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The researcher used a standardized and validated pain scale by Douleur Aigue Nouveau-ne scale (DAN scale).In this study GroupI (Breast milk) and Group II (Oral sucrose) received as analgesic product to avoid procedural pain. The study had shown that breast milk has more powerful analgesic effect than oral sucrose to alleviate procedural pain by using percentage frequency of DAN’s scale score.

A study on heel lance in newborn during breast feeding; an evaluation of analgesic effect of this procedure among 200 healthy full term newborns. for neonatal metabolic screening. Practices such as skin to skin contact, or breastfeeding, in healthy newborn, may represent an alternative to the use of analgesic drugs. The aim of the study is to evaluate the analgesic effect of breastfeeding due to routine invasive procedures like capillary heel sticks blood sampling. Pain assessment was evaluated by DAN scale. The difference in score of pain according to the DAN scale was significant in the two groups of neonates (p = 0.0001); the median score of pain was 5.15 for controls and 2.65 for experimental group (newborns sampled during breastfeeding). The study results have shown the evidence of analgesic effect of breast feeding during heel puncture. ( Elena Uga et al ,2008).

Shah, Aliwalas & Shah (2006) conducted a trial on breastfeeding or supplemental breast milk to alleviate procedural pain in neonates, at Canada. A literature search was performed using MEDLINE, EMBASE, CINAHL and abstracts from the annual meeting of the society for pediatric research. Marked heterogeneity in terms of control intervention and pain assessment measures were noted among the studies. Premature Infant Pain Profile scores were significantly different between the breastfeeding group when compared to placebo group and the group positioned in mother’s arms. Neonates in the breastfeeding group had statistically significant and shows less increase in the heart rate, reduced proportion of crying time and reduced duration of crying compared to swaddled group or pacifier group. Investigator concluded that the breast milk should be used to alleviate procedural pain in neonates.

Emine Efe & Sevim Savafler (2005) did a study on the use of breast feeding for pain relief during neonatal immunization injections at Antalya. The objective of this study was to examine the pain relieving effect of breast feeding during immunization injections in healthy neonates. Sixty six healthy neonates returning to a clinic for their second, third or fourth month immunization with intramuscular diphtheria, tetanus and pertussis were randomized into experimental group and control group. The experimental group received breast milk before, during and after the injection. The control groups were not fed by breast milk before injection according to routine clinic procedure. To assess the pain response of the neonates during and after immunization, the investigators noted their heart rates, oxygen saturation levels and length of crying. The crying time was shorter in the experimental (breast-feeding) group than in the control group .The heart rate and oxygen saturation levels were almost the same in both groups. The study concluded that breast feeding, maternal holding, skin-to-skin contact significantly reduced crying in infants receiving an immunization injection for diphtheria, tetanus and pertussis.

Phillips, Carolin, & Michael (2005) compared the analgesic effects of breastfeeding or pacifier use with maternal holding in procedural pain 96 healthy term neonates. The purpose of study was to assess the differences in outcome measures caused by the effect of breastfeeding (maternal contact).Group I received breast milk, group II were held in the bed by their mothers while giving pacifier and group III neonates were held by the research assistants in bedside chairs while giving pacifier. All the neonates underwent heel lance blood sampling by a single performer. Neonates who were received breast milk (Group I) had shorter duration of cry than mothers held babies in their bed while giving pacifier (group II) while research assistant held infants in bedside chairs (group III). The outcomes measured were crying duration, percentage of infants crying, changes in the heart rate, blood pressure and oxygen saturation. The study had shown breast milk is more analgesic than pacifier use with non-maternal holding.

A study was conducted by Shendurnikar (2005) to compare the effects of breastfeeding to positioning (swaddling) in procedural pain. A total of 100 full term neonates were participated in the study. The neonates were randomized into two groups (50 neonates in each group).Infants in group one were breastfed for 15 minutes prior to heel prick. All neonates underwent heel lance procedure for clinical indication such as measurement of packed cell volume or bilirubin. The outcomes measured were behavioral (state of arousal, cry, facial expression and body movements), physiological (breathing pattern, heart rate). By using standardized pain scale composite score (non validated) between the two groups before, during and after blood collection were measured. Breast feeding group had shown effectiveness on alleviating procedural pain than swaddling group.

Effect of foremilk and hind milk on simple procedural pain among sixty two healthy term neonates at Istanbul, Turkey. The neonates were randomized into three groups. Group I neonates received 2 ml of foremilk, group II hind milk and group III received sterile water. All neonates underwent heel lance blood sampling by single performer. The allocated solution was given by syringe into the baby’s mouth. The heel prick was performed two minutes after administration of the solution. Crying duration and heart rate changes at one, two, and three minutes were recorded from the time of the heel prick. The outcomes measured were crying time, percentage change in heart rate and Neonatal Facial Coding Score at one, two and three minutes. The study concluded that neither foremilk nor hind milk was effective in relieving procedural pain. (Uyan, 2005).

Narayan, Upathayay, Aggarwal, Joshi, Paul & Deorari (2004) investigated a randomized placebo controlled, double-blind trial on analgesic effect of EBM in procedural pain in term neonates. The aim of the study was to assess the effectiveness of EBM in reducing pain due to venepuncture, in term neonates, as measured by behavioural and physiological observation. This trial involved eighty one full terms up to four weeks of neonatal age, who needed venepuncture for blood investigations. Two minutes before the venepuncture, forty babies received five ml of EBM in the experimental group, while forty one babies in control group received five ml of distilled water as placebo. Two observers who are blinded to the intervention recorded the physiological and behavioural parameters. The duration of crying was significantly shorter in babies fed with EBM than in those fed with distilled water . The mean duration of crying in EBM group was shorter by 70.7 seconds. The change in heart rate and oxygen saturation was significantly lower in the EBM group and return to baseline values sooner than in the distilled water group.

Schollin (2004) stated the analgesic effect of EBM on procedural pain in neonates. Prevention, treatment and assessment of neonatal pain have been of major clinical and scientific interest in the last decades. Non-pharmacological interventions such as sweet oral solutions are successful in pain relief. The study concluded that seven percentage of lactose in expressed breast milk was sufficient to alleviate procedural pain in neonates.

Upadhyay (2004) compared the effects of supplemental breast milk with sterile water in procedural pain. This was a randomized controlled trial of 87 full term neonates. The infants were randomized into two groups. Venepuncture was performed based on clinical indications. Data from 81 infants were analyzed. The primary outcome was the duration of the cry after the venepuncture. Only five easily recordable parameters of the Neonatal Facial Coding Score (out of ten) were assessed by investigator. Data on heart rate, oxygen saturation were provided as mean and standard deviation at baseline and three minutes. The mean difference and standard deviation of the difference were calculated assuming 50% correlation between baseline and subsequent findings. The study concluded that supplemental breast milk was effective in reducing pain caused by venepuncture procedure.

A randomized controlled trial investigated to compare the effects of breastfeeding to positioning, sterile water and 30% glucose in procedural pain. This was a of 180 term neonates. In that Group I received breast feeding, group II positioned in mother’s arms, group III received sterile water and group IV were fed 30% glucose. The interventions were started two minutes before the procedure and continued throughout the procedure. Venepuncture was performed when infants were at least 24 hours of age and had not been fed for the previous 30 minutes. The primary outcome was measured by using Douleur Aigue Nouveau-ne scale (DAN), a behavioral scale developed to rate acute pain in term and preterm neonates. The score comprised of three items namely facial expressions, limb movements, and vocal expression with values in each ranging from zero (no pain) to 10 (maximum pain). The study had shown breast feeding has effect on relieving procedural pain than positioning, sterile water and 30% glucose in term neonates. (Carbajal, 2003).

Jatana, Dalal & Wilson ( 2003) conducted study on analgesic effect of oral glucose in neonates undergoing heel punctures for collection of blood for investigations. The sample was 125 full term normal neonates with no history of birth asphyxia or underlying neurological abnormalities requiring heel punctures for collection of blood for various investigations were selected for the study. The study subjects of 125 neonates were divided into five groups of twenty five in each. One group comprised control subjects and was administered sterile water. Three groups were administered one ml of varying strengths of glucose solution i.e., 10%, 20% and 50% respectively. The last group was given one ml of EBM. Prior to heel pricks, state of arousal, baseline heart rate and transcutaneous oxygen saturation were recorded by pulse oximeter in each neonate. Increasing concentration of glucose and EBM have been found to have analgesic effect in full term neonates undergoing heel punctures for routine investigations and can probably be used to provide pain relief in other simple painful procedures.

Larry Gray, Lisa & Barbara (2002) investigated a randomized controlled trial to compare the effects of breastfeeding to positioning in procedural pain at University of Chicago, Illinois. A total of 30 full term neonates were included for this study. The neonates were randomized into two groups (15 neonates in each group).All neonates underwent heel lance for routine neonatal screening procedure. Mean neonatal age at procedure was 46 hours in Group I and 40 hours in Group II. The outcome of the study showed that there were significant differences in crying, grimacing and heart rate in breast feeding groups than positioning group. Thus the researcher concluded that breast feeding reduces procedural pain than positioning during blood collection procedure in neonates.

Leite et al (2002) did a study on effects of breastfeeding on pain relief in full-term newborns. The sample of this randomized clinical trial study consisted of 60 full-term newborns: 31 in the experimental group and 29 in the control group. The experimental group was breastfed five minutes before, during, and for five minutes after the blood collection procedure. Neonates in the control group were held in mothers’ arms but not fed or given a soother. Heart rate was considered as an index of arousal. Sucking frequency was only evaluated in the experimental group. Compared with the control group, the experimental group had significantly lower scores and heart rates changes. In the experimental group sucking frequency was highest during the first five minutes of breastfeeding before the procedure. The conclusion was that breastfeeding was effective in reducing pain caused by blood collection for newborn screening.

Mathi, Natarajan & Rajalakshmi (2002) performed a comparative study of non pharmacological methods to reduce pain in neonates at Coloba, Mumbai. A randomized study was done to compare non pharmacological methods to reduce the pain of heel pricks in 104 stable term neonates. Rocking, massage, 20% sucrose, distilled water (DW) and Expressed Breast Milk (EBM) was used as pain reducing agents. Duration of cry and Douleur Aigue Nouveau-ne (DAN) score were used to assess pain. Physiological parameters were also recorded before and after the stimulus. At 30 seconds after the stimulus, the pain scores were lowest in the sucrose group but this was not sustained at 1, 2 and 4 minutes. At 2 and 4 minutes pain scores were lowest in the expressed breast milk and rocking groups as compared to sucrose, distilled water, and massage. The total duration of crying was also lowest in the EBM and rocking groups.

Blass (2001) conducted a trial on comparison of effects of supplemental breast milk (colostrum) to water and sucrose in procedural pain with 60 full-term neonates. The neonates were between 30 – 55 hrs of age at the time of blood collection for routine neonatal screening using the heel lance procedure. Two ml of the allocated solution was given either by slow administration via syringe over a span of two minutes or by allowing neonates to suck a pacifier dipped in the solution every 30 seconds for two minutes. Prior to the procedure, baseline data were obtained for 60 seconds and continuous monitoring was done throughout and after the procedure during the recovery time. The outcome of the study showed that there was a reduction in the percentage of crying and grimacing times in the supplemental breast milk group during the procedure. The study had also shown that supplemental breast milk was effective than sucrose in alleviating procedural pain in full term neonates.

Ricardo Carbajal, Soocromanien veerapen, Sophie Coudere, Myriam Júgie & Yves Ville (2001) performed randomized controlled trial on analgesic effect of breast feeding among one hundred and eighty term neonates at Poissy-Saint German hospital. The study subjects were randomized into four groups, forty five in each group. During venepuncture the group I neonates were breast fed, group II neonates were held in their mother’s arms without breast feeding , group III neonates received one ml of sterile water as placebo and group IV neonates were given one ml of 30% glucose followed by pacifier. Video recordings of the procedure were assessed by two observers blinded to the purpose of the study. Pain related behaviours were evaluated with two acute pain rating scales: the Douleur Aigue Nouveau-ne scale and the Premature Infant Pain Profile scale. Analysis of the data revealed that there were significant reductions in both scores for the breast feeding and glucose plus pacifier groups compared with the other two groups (p < 0.0001). The study concluded that breast feeding effectively reduces response to pain during minor invasive procedures in term neonates.

A randomized controlled trial was conducted by Bucher (2000) on comparison of effects of artificial sweetener containing ten parts cyclamate and one part saccharin to glycine (sweet amino acid), expressed breast milk and sterile water among eighty full-term infants. by a nurse not involved in the study. Prior to the procedure, two ml of the allocated solution was given via syringe on the anterior part of tongue and baseline data were obtained throughout and after the procedure during the recovery time. The procedure was video taped and evaluated by two independent observers unaware of allocation. The outcomes measured were reduction of heart rate change, percentage of time crying, facial pain score (five components of NFCS) and body pain score during blood collection. Breast milk group had significant reduction in heart rate change, percentage of time crying, facial pain score and body pain score. The study had shown breast milk has effectiveness than artificial sweetener and sterile water.

Okan, Ozdil, Bulbul, Yapici & Nuhoglu (2000) conducted study on analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates at Turky. A randomized, controlled trial was conducted among 107 neonates undergoing heel-lance. Neonates were randomly assigned to three groups. Group I were being breastfed with skin-to-skin contact, group II neonates being held in their mother’s arms with skin-to-skin contact but no breastfeeding, and group III neonates were made to lie on the table before, during and after painful stimulus. Physiological responses to pain were measured by heart rate and oxygen saturation changes and behavioural responses were measured by duration of crying and grimacing. Heart rate, oxygen saturation changes and length of crying were significantly reduced in groups I and II compared with group III. No differences were found between group I and group II. Grimacing was less in group II than in group III. In healthy term neonates, skin-to-skin contact with the mother and breastfeeding with skin-to-skin contact reduces both physiological and behavioural pain response.

Ors (1999) compared the effects of supplemental breast milk to water and 25% sucrose in procedural pain. This was a randomized controlled trial of 102 healthy term neonates. The neonates were randomized into three groups. Group I received supplemental breast milk, group II received sterile water and group III received 25% sucrose. All neonates underwent heel lance blood sampling by a single performer. The allocated solution was given by syringe into the baby’s mouth over one minute. The heel prick was performed two minutes after administration of the solution. Crying duration and heart rate at three minutes were recorded from the time of the heel prick. The outcomes measured were crying time, percentage change in heart rate and recovery time for the heart rate. The supplemental breast milk had shown significant reduction in crying time, percentage change in heart rate than the other two groups.

Skogsdal (1997) performed a randomized controlled trial among 120 neonates to compare the effects of no intervention to 30% oral glucose, 10% oral glucose and breast milk in procedural pain. The neonates were randomly assigned to one of the following groups (30 neonates in each group).The neonates were studied on mean and standard deviation of fifth neonatal age at the time of blood collection for their routine care using the heel lance procedure. One ml of allocated solution was given via syringe by a nurse not aware of allocation. Prior to the procedure, baseline data were obtained and continuous monitoring was done throughout and after the procedure during the recovery time. The blood collection was performed two minutes after administration of solution. The outcomes measured were heart rate change and duration of crying. The study results showed that breast milk was effective on procedural pain than the glucose solution in newborns.

Section D: Studies Related To Using Breast Milk In Other Conditions.

Penjvini, Shahasavari, Gazerani & Abdolkavand (2009) performed a randomized study on the effectiveness of topical use of human breast milk for diaper rash in hospitalized infants at Sanandaj. The study subjects for the study were 50 newborns, which were divided into two groups. Group I received human breast milk application and group II received zinc oxide ointment. After each diaper change the affected area was cleansed with water followed by application of human breast milk or zinc oxide. Infants were assessed twice a day for three days. The diaper rash were measured by using a sterilized ruler put along the lesions in a way that 3’2 cm2 = large size, 2’2 cm2 = moderate size and less than 1’2 cm2 = small size. There were significant differences between human milk and zinc oxide groups. The researcher concluded that topical application of breast milk was effective treatment for diaper rash.

Sergio, Alejandro & Palma (2008) conducted a switch from antibiotic eye drops to instillation of mother’s milk drops as a treatment of infant epiphora. The management of newborns with signs and symptoms of congenital naso lacrimal duct obstruction was switched from topical antibiotic to topical mother’s milk-based regimens. The conservative management of this condition includes frequent cleansing of the lids, digital lacrimal sac massage and application of topical antibiotic drops when there was a mucopurulent discharge. This change was initiated by some others who have applied traditional therapy such as instillation of mother’s milk as eye drops. This study concluded that instillation of mother’s milk drops had effectiveness than antibiotic eye drops in the treatment of infant epiphora.

Gulsen Vural & Sezer Kizar (2006) did a case control design on umbilical cord care: comparing topical human milk, povidone iodine and dry cord care, in Urban University Hospital at Turkey. The study subjects were 150 newborns which were divided into three groups. Each group had 50 newborns. Group I received breast milk on their umbilical cord and group II received povidone iodine and Group III received dry cord care. This study showed that dry cord care and breast milk group had shorter cord separation time than those in povidone iodine group.

Tafazoli, Mohammed Zadeh, Esmaeili & Ghazvini (2006) investigated a randomized clinical trial study on effectiveness of topical application of breast milk on umbilical cord for bacterial colonization at Omolbanin Hospital, Mashhad. The study subjects for this study were 118 newborns, divided into two groups. In each groups 59 newborns were allotted. Group I newborns received breast milk on their umbilical cord whereas group II newborns received dry cord care. All mothers in both groups were instructed about care of umbilical cord within three hours of birth. Group I newborns were applied breast milk to the umbilical stump three hours after birth and continued every 12 hourly until two days after cord separation. Nothing was applied to the umbilical stump of the dry cord care group. The researcher obtained an umbilical swap three hours after birth and the third day of life from the base of the cord. Rate of bacterial colonization were recorded in both groups. The researcher found out that most common cultured organisms were S.epidermidis, S. aureus, E. Coli and Klebsiella pneumonia in the umbilical stump and there were significant differences between dry cord care and human breast milk groups in colonization rate. Topical application of breast milk on umbilical cord leads to reduced bacterial colonization and cord separation time and it can be used as easy, cheap, non-injury methods for umbilical cord care.

A study on application of human colostrum for prophylaxis against sticky-eyes and conjunctivitis in newborn at All India Institute of Medical Science, New Delhi. The study subjects were 150 newborns, which were divided into two groups containing 75 newborns in each. Group I (experimental group) received human colostrums application to their both eyes three times a day for three consecutive days whereas group II (Control group) did not received any application in their eyes. In both experimental and control groups, swabs were taken from two conjuctival sacs within 12 hours after birth for bacterial culture and sensitivity. No special instructions were given regarding cleanliness of the eyes but all mothers were specifically told to avoid the local application of any indigenously prepared eye medications. On the fourth day repeat conjunctival sac swab was taken for bacterial culture and sensitivity from both the groups. A careful examination of the eyes in good day light was made twice a day. The experimental group had significantly lower bacterial colonization rate than in the control group. The researcher concluded that conjunctival application of human colostrums on conjuctival sac was an effective method of prophylaxis against sticky eyes and conjunctivitis in newborns. (Meharban Singh, Sugathan & Bhujwala ,1982).

CHAPTER III

RESEARCH METHODOLOGY

Research methodology refers to the techniques used to structure a study and to gather and analyze information in a systematic fashion (Polit & Hungler, 2008). Methodology includes the steps, procedures and strategies for gathering and analyzing the data in the research investigation.

This chapter consists of research design, variables in the study, setting of the study, population, sample size, sampling technique, criteria for selection of sample, development and description of the tool, scoring key, content validity, pilot study, reliability, data collection procedure and plan for data analysis.

RESEARCH DESIGN

Research design adopted for this study is after-only design of basic experimental design which comes under true experimental design as the study fulfills the criteria such as manipulation, randomization and control. It can be diagrammatically represented as

Group

Intervention

Post Test

Experimental Group

–

RC1

Control Group

X

RE1

Fig 2: Schematic Representation of True Experimental Design.

X – Oral administration of five milliliter of expressed breast milk

RC1- Post test level of behavioural response in randomized control group.

RE1- Post test level of behavioural response in randomized experimental group.

VARIABLES

Independent variable

Expressed breast milk

Dependent variable

Behavioural response

Extraneous variable

Holding, Positioning, Distraction, Breast Feeding before venepuncture, Age, Sex, Birth Weight, Congenital Anomalies.

Setting of the Study

The study was conducted at neonatal ICU in Krishna Maternity Home and Pediatric centre. This is an ISO: 9001-2008 certified organization and located in Palayamkottai, three kilometers from Tirunelveli. The hospital is a 150 bedded multi specialty centre with 24 hours emergency care.

POPULATION

Neonates with gestational age of 38- 42 weeks who were admitted in Krishna Maternity home and Pediatric centre at Tirunelveli. The census of the babies in neonatal Intensive Care Unit (ICU) per day was approximately three to five babies who received venepuncture procedures. which amounts to twenty one to thirty five newborns per week, eighty four to hundred newborns per month.

SAMPLE

The study samples were full term neonates admitted in Krishna Maternity Home and Paediatric Centre and those who fulfilled the inclusive criteria of the study.

SAMPLE SIZE

Total sample size was sixty newborns. Among thirty of them in experimental group and remaining thirty new borns in control group.

SAMPLING TECHNIQUE

The samples were selected by using of probability sampling technique under which the investigator selected the simple random sampling technique by using the tossing a coin. Newborns who came under head will come under the experimental group and newborns who came under tail will come under the control group.

CRITERIA FOR SAMPLE SELECTION:

Inclusive Criteria.

The newborn in the age group of 0 to 28 days and those admitted in Krishna Maternity Home and Pediatric Centre,at Tirunelveli.

The newborns who are born with the gestational age of 38-42 weeks.

The newborn who are present at the time of data collection.

The mothers who are willing to participate with their newborn in this study.

Exclusive Criteria:

The newborn who are critically ill.

The newborn who are having congenital anomalies.

The newborn who are having more than four kgs of birth weight.

Development and Description of Tool

Part : I

Questionnaire to collect demographic data of the samples which consists of four items. They were age, sex, birth weight & congenital anomalies.

Part : II

Consists of Neonatal Infant Pain Scale (NIPS). It consists of facial expression ,cry, breathing patterns , arms , legs ,state of arousal.

Neonatal infant pain scale (NIPS) is the standardized tool which was devised by Lawrence et al (1993) to assess the behavior of preterm and full-term neonates in response to the pain of needle puncture.

SCORING KEY:

Total score – 7

0 -3 Behavioural response which indicates no pain to venepuncture.

4 -7 Behavioural response which indicates pain to venepuncture.

CONTENT VALIDITY

The content of the tool was established on the basis of opinion of one medical expert and three nursing experts in the field of pediatric nursing. Slight modifications were done as per the suggestion of the experts in the tool.

PILOT STUDY

It is a rehearsal for the main study. The researcher got permission from Principal and Research ethical committee of Sri. K. Ramachandran Naidu College of nursing and HOD of child health nursing. A formal permission was obtained from the Director of the Center. The pilot study was conducted in Neonatal ICU for the period of one week (30.03.2010 to 03.04.2010) from 9 am to 6 pm. The concerned ward in charge and duty doctors were also informed and their co-operation was also obtained. The sample size was six newborns and they were selected by using lottery method of simple random sampling technique, in that three of them were allotted to experimental and three of them to control group.

Rapport was established with the mothers and a brief introduction about the study was given. Consent was obtained from each mother and reassurance was provided that the collected data would be kept confidential. The data related to demographic variables were collected from the medical records. Five milliliter of expressed breast milk was collected from the mothers in paladai and orally administered in the anterior tongue by using disposable syringe two minutes before venepuncture to the experimental group. The control group was not fed any solution before venepuncture. Assessment of the behavioural response was done by using NIP scale. The results of the pilot study showed that the experimental group had a favourable behavioural response as compared to the control group. The study was found to be feasible and hence the same procedure was decided to be followed in the main study. There was no modification made in the tool after pilot study. The samples selected for the pilot study were not included for the main study.

RELIABILITY OF THE TOOL

Hence the tool was standardized one and university acceptable the researcher did not check the reliability.

PROCEDURE FOR DATA COLLECTION

The researcher got permission from Principal and research ethical committee and HOD of child health nursing, Sri K. Ramachandran Naidu College of Nursing. Before the data collection a formal permission was obtained from the Director of Krishna Maternity Centre and Pediatric Center, at Tirunelveli for conducting main study.

The data were collected from 03.05.2010 to 29.05.2010, between 8.00 a.m. to 4 p.m, six days in a week. Newborns who required venepuncture were selected by using lottery method of simple random sampling technique according to the inclusive criteria after obtaining the consent from the mothers of the newborn. The researcher collected the neonates’ demographic data from the medical records. Five milliliter of expressed breast milk was collected from the mothers in paladai and it was orally administered in the anterior tongue by using disposable syringe two minutes prior to venepuncture to the experimental group. The control group was not fed any solution before venepuncture. During the procedure, the researcher assessed the neonates’ behavioural response about two minutes with NIPS. The data were collected approximately three to four study subjects per day.

PLAN FOR DATA ANALYSIS

The data were analyzed by using descriptive and inferential statistics.

Descriptive Statistics

1. Frequency and percentage distribution were used to analyze the demographic data.

2. Mean and Standard deviation were used to assess the effectiveness of oral administration of expressed breast milk on behavioural response of term newborns.

Inferential Statistics

1. Unpaired ‘t’ test was used to compare the effectiveness of oral administration of expressed breast milk on behavioural response of newborns among experimental and control group

2. Chi-Square test was used to find out the association of the effectiveness of oral administration of expressed breast milk on behavioural response of newborns with their selected demographic variables of experimental and control group.