The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns
Condition: Newborn; Pain; Maternal; Procedure; Needle Stick
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      This study was planned to evaluate the effect of two different non-pharmacologic pain relief
      methods (swaddling and maternal holding) on healthy term newborn's pain levels during heel
      stick.

      Study hypotheses are; Hypothesis 1. Swaddling is effective at relieving pain due to heel
      stick procedures in newborns. Hypothesis 2. Maternal holding is effective at relieving pain
      due to heel stick in newborns. Hypothesis 3. Maternal holding is more effective than
      swaddling at relieving pain due to heel stick in newborns.
    

Detailed description: 
      This study was conducted in the baby's nursery of Bandirma State Hospital, Turkey between
      March and June 2016. It was designed as a prospective randomized clinical trial that
      evaluated and experimentally determined the effects of swaddling and maternal holding during
      heel stick on pain levels in healthy term neonates.

      The study comprised all newborns who came to the baby's nursery for a heel stick procedure
      for routine metabolic screening; the study sample consisted of 105 healthy newborns who
      matched the case selection criteria and underwent heel stick. The inclusion criteria were as
      follows: full term neonates (38-42 weeks of gestation) who underwent heel stick blood drawing
      for routine metabolic screening, were aged 2 to 4 days, and had passed the hearing screening.
      Babies with congenital anomalies were excluded from the study.

      In the power analysis conducted using heel stick literature1,4,9, the sample size required
      for 80% reliability and α=0.05 was 35 in each group; the total was 105. Neonates were
      randomized into three groups and 35 babies were evaluated in each group (swaddling [n=35],
      maternal holding [n=35], control [n=35]) (Figure 1). Numbers from 1-105 were randomly
      distributed by a computer program to the three groups with no number repetition to determine
      which child would be allocated to which group.

      The study data were obtained using an information form and the Neonatal Infant Pain Scale
      (NIPS).

      Information Form: This form contained questions about the sociodemographic characteristics of
      the neonate and family. It consisted of 20 questions in total comprising personal
      characteristics information of the families, and sex, delivery method (vaginal or cesarean),
      gestational age, birth weight, postnatal age (hours after birth) of the neonate and period of
      procedures.

      Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate
      behavioral and physiologic pain responses of preterm and term infants. The scale was adapted
      to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the
      interventional (procedural) pain level of newborns. The scale consists of five behavioral
      (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic
      (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to
      other indicators, and the total score is between 0 and 7. High scores indicate that the
      severity of pain is excessive.

      Data collection All blood sampling was performed in a quiet nursery room between 09:00 AM and
      11:00 AM, 1-2 hours after breastfeeding, the normal time when infants undergo heel stick for
      routine blood collection for metabolic screening. Blood collection was performed in a
      standardized manner by the same nurse who has a minimum of 5 years' experience in the
      performance heel stick and had no conflict of interest. A pediatrician made the clinical
      decision for heel stick.

      Before the procedure, the newborns were kept in a quiet room far away from the cries of other
      babies. The infants' diapers were changed before procedure. For the heel stick procedure, the
      antiseptic solution (70% alcohol), heel stick method, heel region for sampling (the outer
      right side of the ball), needle (21-G needle), and environmental factors such as heat, light,
      and noise were all standardized. The whole procedure was video-recorded until three minutes
      after the procedure.

      At the beginning of the study, the parents of the newborns were informed about the aim and
      content of the research, and parental approval was obtained. Neonatal and family demographics
      were collected using self-report information forms, which included medical history, mother's
      gestational age, neonatal age, sex, birth weight, duration of sampling, total crying time,
      processing time, and the time from the start of the first cry to the first crying during the
      process.

      All blood sampling in the study was performed for clinical purposes, such as newborn
      metabolic screening tests, which were taken on the second to third days following birth. The
      standard protocol for blood sampling involved swabbing the heel with a small gauze pad with
      disinfectant, lancing the heel, and then gently squeezing the heel intermittently until the
      amount of blood required for clinical use was collected.

      All procedures performed in the experimental and control groups were video recorded by the
      researcher from the beginning of the procedure. After the procedure the newborns' pain levels
      and crying duration were evaluated using the video recordings. Assessment of pain was
      conducted independently by the investigator and the nurse using NIPS. At the same time, the
      newborns' total procedural crying time, the duration of the procedure, and the first calming
      time were recorded. The total crying time of the newborns was measured from the start of
      crying due to heel stick to the complete cessation of crying. The time of the procedure was
      measured from the beginning to the end of the heel stick procedure. The calming time was
      measured from the time of the first cry to the first calming time.

      The SPSS (version 19) program was used for statistical analysis. Descriptive statistical
      methods (mean, standard deviation, median, frequency, rate, min., max.) were used when study
      data were evaluated. The one-way Anova test was used in the comparison of data of the three
      groups with normal distribution. The Kruskal-Wallis test was used in the comparison of data
      of the three groups with non-normal distribution. The Mann-Whitney U test was used to
      identify the group that caused the difference. Pearson's Chi-square test and the
      Fisher-Freeman-Halton test were used for the comparison of qualitative data. Significance was
      considered as p<0.05.
    

Intervention name(s): Swaddling; Maternal holding
Intervention type(s): Other; Other
Intervention description(s): Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.; Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.
Other intervention name(s): Group 2; Group 3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Newborn; Pain management; Swaddling; Maternal holding; Heel stick