CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Swaddling +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04625010
NCT04625010N/ACompleted

The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

Istanbul University - Cerrahpasa·interventional·Posted Nov 12, 2020·Updated Nov 12, 2020

In Brief

A clinical study evaluating Swaddling and Maternal holding for Newborn and 3 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 12, 2020
Enrollment StartMar 1, 2016
Primary CompletionJun 1, 2016
Study CompletionDec 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.6 years ago

Interventions

Swaddlingother

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.

Maternal holdingother

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.