Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage [1]. Newborns are especially vulnerable to pain and its deleterious effects. Babies have larger receptive fields for nociceptive impulses and possibly a higher density of nerve endings and concentration of substance P receptors [2,3]. The density of proprioceptive nerve ending is equal to the adult [4]. In neonates, the harmful effects of pain include irritability, fear, sense of mistrust towards caregiver, disturbed sleep and wakefulness cycle, delayed wound healing, altered immunological functions, biochemical alterations in energy metabolism. Negative effects on the developing brain also include long-term adverse effects like subtle behavioral changes that may persist up to childhood. Neonates are exposed to various types of painful stimuli in the indoor and outdoor settings. Hence it is very important to have effective tools for the assessment and management of pain. The responses to pain in a newborn are nonverbal which include physiological, behavioral, biochemical, autonomic change and body movements [5]. These parameters are used for pain assessment in various scales [6].

These can be used by the health functionaries to assess pain and evolve strategies to prevent, reduce or eliminate pain. There have been many pharmacological and nonpharmacological methods which are being evaluated in the recent past for effective management of the pain in newborns. The pharmacological agents like paracetamol, opiates, and local anesthetic agents can be useful for severe pain management [7]. While nonpharmacological methods can be effective for the mild to moderate intensity pain relief. Various nonpharmacological methods mentioned in literature nonnutritive sucking (NNS), glucose solution, breastfeeding (BF), kangaroo position, rocking, music therapy, massage therapy, and distilled water (DW) [8-11]. These methods are low cost, simple and benign and have been found effective. Pain assessment in newborns is a special challenge due to the physiological handicaps of neurological and developmental functions. Various methods used for pain assessment are Neonatal Infant Pain Scale, premature infant pain profile, revised Faces Pain Scale, and Douleur Aigue Nouuveau-ne (DAN). DAN score designed in 1997 is acute pain rating scale in neonates. DAN score is a reliable and valid method of pain assessment in the procedural pain. It is based on the 3 parameters; facial expression, limb movements, and vocal expression. The score is assigned on these parameters depending upon the response of newborn to the painful stimulus. Total of the scores on 3 parameters is used to quantify pain experienced by the newborn [6].

Vaccination during the neonatal period is one of the most common mild to moderate painful experience to which newborns are subjected to universally [12]. So it will be worthwhile to find the effectiveness of various nonpharmacologic methods in reducing the pain in newborns during the vaccination. So, we planned this study to find and compare the effectiveness of various nonpharmacological methods in the newborn pain management during the vaccination.

The aims and objectives are as follows: (1) To study the effectiveness of various nonpharmacological methods i.e.; ① BF, ② nonnutritive sucking, ③ rocking, ④ 25% sucrose, and ⑤ water in reducing the pain in newborns induced during the first dose of intramuscular hepatitis B vaccine. (2) To compare the effectiveness of various nonpharmacological methods i.e.; ① BF, ② nonnutritive sucking, ③ rocking, ④ 25% sucrose, and ⑥ water in reducing pain on the duration of cry after vaccination and DAN score at 30, 60, and 120 seconds.

Three hundred newborns were studied over a period of 6 months. There were 159 males (53.1%) and 141 females (46.9%). The demographic profile of the newborn enrolled in the study under various groups was comparable (Table 1). Comparison of mean duration of cry in different intervention groups with the control group using unpaired t test showed that there was a decrease in duration of cry in all the intervention groups after vaccination in comparison to control group (P<0.05) (Table 2). The difference observed in BF, NNS, and 25% sucrose groups were statistically significant (P value while in rocking and DW groups, the difference was not significant). The difference was statistically highly significant in the group receiving 25% sucrose and BF (P<0.000). ANOVA was conducted to compare the difference in analgesic effect of various interventions groups namely BF, NNS, rocking, 25% sucrose, and DW in reducing pain assessed by DAN scores at 30, 60, and 120 seconds. It was observed that there was significant difference of DAN (30 seconds) at P<0.05 between different interventions (F [5, 294]=5.049, P≤0.000). Post hoc comparison using Tukey honestly significant difference (HSD) indicated that mean DAN (30 seconds) score for sucrose intervention (3.10±1.875) was significantly different from the DAN (30 seconds) score in BF (4.54±1.727), NNS (4.64±1.526), rocking (4.58±2.139), and control (5.00±2.283). While ANOVA exhibited no significant effect of DW intervention (3.97±2.025) on DAN (30 seconds) score. Similarly it was observed that there was significant difference of DAN (60 seconds) at P<0.05 between different interventions (F [5, 294]=8.8081, P=0.000) on post hoc comparison using Tukey HSD mean DAN (60 seconds) score for sucrose intervention (0.58±0.8) was significantly different from NNS (1.9±1.5), rocking (2.23±2.3), DW (1.65±1.7), and control (2.82±2.3) while ANOVA exhibited no significant effect when compared with breastfed group (P>0.05) means these intervention are equally effective in reducing pain scores after 60 seconds of painful stimuli. For DAN (120 seconds) scores found to be significantly different in sucrose (0.05±0.22) and rocking (1.04±2.05) intervention (P<0.05) while no significant difference was observed with other interventions. DAN score was reduced in all the intervention groups at 30, 60, and 120 seconds in comparison to control except at 30 seconds for DW group. However, this decrease was significant (P<0.05) only in 25% sucrose at 30, 60, and 120 seconds and at 60 and 120 seconds in BF group. In intergroup comparison, a significant difference was observed for DAN (30 seconds) at P<0.05 between sucrose and other interventions. On post hoc comparison using Tukey HSD indicated that mean DAN (30 seconds) score for sucrose intervention was significantly lower than BF.

Similarly, a significant difference was observed for DAN (60 seconds) at P<0.05 between different interventions. Mean DAN score (60 seconds) for sucrose intervention group was significantly lower than NNS followed by rocking and DW group while ANOVA exhibited no significant difference between 25% sucrose with BF group (P>0.05). Further, DAN score (120 seconds) found to be significantly lower in 25% sucrose in comparison to rocking intervention P<0.05 while it showed no significant difference with other interventions. The pain intensity was significantly lower at 30 seconds in BF and 25% sucrose group. Comparison of DAN scores at 30, 60, and 120 seconds in intervention groups with control group have shown statistically significant reduction (P<0.05) at one or more point i.e., at 30, 60, or 120 seconds in BF and 25% sucrose intervention group when compared with control (Table 3).

The analgesic effects of various nonpharmacological methods in newborns have been studied in the past and their results are varying. However, there are no comprehensive and definite recommendations for their regular use in day to day clinical scenarios. Our study has been carried out for the same purpose. We have studied the effectiveness of 5 nonpharmacological methods during painful stimulus of HBV vaccination. We conducted our study over a period of months involving 300 newborns divided into 6 equal groups. Groups 1–5 received 1 of the 5 nonpharmacological methods and constituted the intervention groups while the group 6 acted as the control. Most of these studies done in this regard had quite a less number of the cases as compared to our study. Above this, most of them evaluated 2 or 3 methods in a particular study as compared to our study where we have evaluated the analgesic effect of 5 nonpharmacological methods simultaneously. Gray et al. [14] studied the analgesic effect of skin-to-skin contact during heel stick in newborns and found it to be potent intervention in reducing the pain. Carbajal et al. [15] 2003 studied the effectiveness of BF and a combination of sucrose and pacifier in pain reduction and the result were comparable between 2 groups. Gray et al. [16] found that newborns if put on BF before, during, and after the heel prick had reduced crying and grimacing and it also prevented an increase in heart rate. Yılmaz et al. [17] reported that holding the baby in arms in the upright position decreased the duration of crying during painful stimulus of heel prick. Ozdemir and Tüfekci [18] recorded lower pain score and shorter crying duration in response to vaccination using music as an intervention.

Our study has shown that all the intervention groups 1–5 lower mean duration of cry after vaccination as compared to control group. Mean duration of cry in 3 groups namely 25% sucrose, BF, and NNS was 19.90, 31.51, and 36.93 seconds, respectively which was statically significantly lower as compared to control group which has the mean duration of the cry of 52.86 seconds. The mean duration of cry was lowest in 25% sucrose group. The difference between BF and 25% sucrose group was not significant.

The mean duration of cry in rocking and DW group was lower as compared to control but the difference was not significant. On serial observation of the DAN score at 30, 60, and 120 seconds after vaccination it was observed that DAN score was lower in all the intervention groups as compared to control group except DW group at 30 seconds. Their results were same as found in our study and both the methods [15]. Taddio et al. [8] studied analgesic effect of sucrose during various procedures in newborn and found that the effectiveness of sucrose was limited to venipuncture for the newborn and not during the intramuscular vitamin K injection. Carbajal et al. [15] reported the analgesic effect of sucrose and pacifiers during venipuncture and found that the analgesic was even better when both used together. On intergroup comparison in various intervention groups, sucrose was found to be the best as it significantly reduced the pain as shown by the serial observations of DAN scores. BF was the secondbest option in pain reduction as it also reduced the pain intensity significantly at all the observations except DAN at 30 seconds. NNS has reduced the duration of cry significantly after painful stimulus but the decrease in DAN scores was though seen but not significant. DW and rocking have shown to decrease the duration of cry and DAN scores but these observations were not significant. Above observations demonstrate that sucrose and NNS are the effective nonpharmacological means of reducing the pain during mild to moderate painful stimuli. Sucrose has shown a better analgesic effect in comparison to BF only at DAN score at 30 seconds. At the rest of the observations, both these interventions were comparable. BF is a physiological phenomenon and its great benefits to the newborn, mothers and community on various aspects are well established and beyond doubt. So, it is recommended that BF is one of the effective and useful ways to decrease pain in newborns. During nonavailability of BF other methods like 25% sucrose or NNS can be employed in the pain management of newborns.

Limitations in our study were as follows: blinding of observer doing DAN scoring and observing total duration of cry was not possible in various groups. Secondly during DAN scoring in the BF group only half of the face was visible to the observer.

Pain has short- and long-term negative effects in newborns. Various nonpharmacological methods are safe, simple, easily available, and effective tools in pain management in newborn. BF is a physiological phenomenon and along with its all other advantages, can be used as an effective tool to manage mild to moderate pain in newborns and during nonavailability of BF other methods like 25% sucrose or NNS can be employed. Efficacy of nonpharmacological interventions in reducing mild to moderate procedural pain is already proven in many studies still there are no definite guidelines which method is superior. We comprehensively studied 5 parameters at the same time in contrast to the other studies in past who had studied 1 or 2 interventions. Moreover, we had a higher number of the subjects in each group in contrast to previous studies. In addition to breast feeding hence our findings carry better meanings in the formulation of operational guidelines.