CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Mother voice +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05079594
NCT05079594N/ACompleted

Investigation of Infant Comfort Levels and Mothers' Anxiety Levels in Non-pharmacological Maternal Voice and White Noise Methods in Heel Blood Procedure

Akdeniz University·interventional·Posted Oct 15, 2021·Updated Dec 5, 2023

In Brief

A clinical study evaluating Mother voice and White noise for Pain, Acute. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The heel blood procedure for newborn screening is done for almost all babies within the first 48 hours of birth. It is stated that non-pharmacological methods in reducing pain during the heel blood collection process are simple, effective, free, and very cost-effective. Studies have shown that auditory interventions (such as mother's voice, white noise) used in invasive procedures distract the infant and create a cognitive strategy for pain control. According to this information, one aim of the study is to determine the effect of the mother's voice and white noise, which are non-pharmacological methods, on the comfort level of the baby in the heel blood procedure. It is thought that especially acute painful procedures applied to infants will reduce the level of stress and anxiety in parents. Another aim of this study is to determine the effect of a mother's voice and white noise, which are non-pharmacological methods, on the state anxiety levels of mothers in the heel blood collection process.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 15, 2021
Enrollment StartMar 15, 2021
Primary CompletionJan 15, 2022
Study CompletionJan 16, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago

Interventions

Mother voiceother

Five minutes before the procedure, the mother's voice recording will be played to the baby and the speaker will be placed 30 cm away from the baby. The baby's comfort level will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale" 2 minutes before the procedure begins. Physiological values of the baby will be noted by the researcher 1 minute before the procedure.As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the "Newborn Comfort Behavior Scale" by the researcher. After the procedure, the recording will continue to be played until the baby's mother's voice returns to the basal values. Physiological values and comfort levels of the baby will be noted by the researcher 1 minute and 2 minute after the procedure. 2 minutes after the procedure, the baby's comfort level will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale".

White noiseother

Before Operation The decibel meter will be set to an average of 50-60 dB and the speakers will be played at a distance of 30 cm. Intervention in this group will be made at the elevation. White noise will be played five minutes before the procedure.The baby's comfort level and physiological values will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale" 2 minutes before the procedure begins. Order of Operation As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the "Newborn Comfort Behavior Scale" by the researcher. Post-Processing After the procedure, white noise will continue to be listened to until the baby's physiological values return to basal values. Physiological values and baby's comfort level of the baby will be noted by the researcher 1 minute and 2 minute after the heel blood collection is completed.