CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Breast milk olfactory stimulation +1 morebehavioral
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/NCT05444608
NCT05444608N/ACompleted

Evaluation of the Effect of Use of Breast Milk Odor and White Noise on Pain Management During Heel Lance in Premature Newborns: A Randomized Controlled Study

Ankara University·interventional·Posted Jul 6, 2022·Updated Nov 22, 2023

In Brief

A clinical study evaluating Breast milk olfactory stimulation and White noise auditory stimulation for Pain. Completed, enrolled 66 participants across 1 site.

Detailed Summary

This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial. The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.

Study Details

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

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 6, 2022
Enrollment StartMay 16, 2022
Primary CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.0 years ago

Interventions

Breast milk olfactory stimulationbehavioral

Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.

White noise auditory stimulationbehavioral

Before the intervention, a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure and will continue to listen for 5 minutes after the procedure.