The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns

NCT05079594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

  • Pain, Acute

Interventions

OTHER

Mother voice

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".

OTHER

White noise

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.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • Uğur Gül · Akdeniz Universitesi, Akdeniz University Faculty of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-01-15
Completion
2022-01-16

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079594 on ClinicalTrials.gov