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Clinical Trials/NCT06053931
NCT06053931
Not yet recruiting
Not Applicable

The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort During Breastfeeding: a Randomized Controlled Trial

Celal Bayar University1 site in 1 country90 target enrollmentOctober 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music
Sponsor
Celal Bayar University
Enrollment
90
Locations
1
Primary Endpoint
mother's comfort in lullaby group
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

In the literature, music plays an energizing, soothing, stimulating and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby. In addition, it is stated that relaxing music in the early postpartum period supports breastfeeding behaviors of mother and baby. It is stated that lullabies positively affect the newborn's relaxation, falling asleep, and mother-baby communication. however, it facilitates sleep due to its monotonous, emotional and repetitive melody structure, slow tempo and relaxing effect. The sound called white noise is a humming, monotonous and constantly used sound that suppresses the disturbing sounds coming from the environment and has a calming feature. In the literature, it has been found that white noise played to infants with colic reduces crying.

The aim of this study is to determine the effects of lullabies and white noise music played during breastfeeding of the newborn on newborn stress, breastfeeding success and mother's comfort. This study was planned as a randomized controlled trial with term newborns 24 hours after birth.

Detailed Description

The hypotheses are presented below; H1- White noise music played during breastfeeding reduces newborn stress compared to the control group. H2- White noise music played during breastfeeding increases breastfeeding success compared to the control group. H3- White noise music played during breastfeeding increases comfort of the mother compared to the control group. H4- Lullaby music played during breastfeeding reduces newborn stress compared to the control group. H5- Lullaby music played during breastfeeding increases breastfeeding success compared to the control group. H6- Lullaby music played during breastfeeding increases comfort of the mother compared to the control group.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
January 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Over 18 years of age,
  • Able to speak Turkish,
  • Breastfeeding mothers
  • Term and healthy newborn (born at 38-42 weeks, weighing 2500-4000 g, born with an APGAR of 7 or more, without any known congenital disease)

Exclusion Criteria

  • mothers who do not agree to participate in the research
  • mother has a condition that prevents breastfeeding

Outcomes

Primary Outcomes

mother's comfort in lullaby group

Time Frame: from pre-intervention to 15 minutes after listening to lullaby.

Change in mother's comfort from pre-intervention to 15 minutes after listening to lullaby during breastfeeding.

newborn stress level in white noise group

Time Frame: from pre-intervention to 2 minutes after listening to white noise music.

Change in newborn stress level from pre-intervention to 2 minutes after listening to white noise music in the first minute of breastfeeding. "Newborn Stress Scale" including facial expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each parameter was scored on a scale of 0-2. The minimum score was 0, and the maximum score was 16 for this scale, where a higher score represented increased stress levels in newborn.

newborn stress level in lullaby group

Time Frame: from pre-intervention to 2 minutes after listening to lullaby.

Change in newborn stress level from pre-intervention to 2 minutes after listening to lullaby. "Newborn Stress Scale" including facial expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each parameter was scored on a scale of 0-2. The minimum score was 0, and the maximum score was 16 for this scale, where a higher score represented increased stress levels in newborn.

mother's comfort in white noise group

Time Frame: from pre-intervention to 15 minutes after listening to white noise music

Change in mother's comfort from pre-intervention to 15 minutes after listening to white noise music during breastfeeding. The number "0" on the the Visual Analog Scale indicates that it is not comfortable at all, the comfort increases as the numbers get larger, and the number "10" indicates that the comfort is complete.

Secondary Outcomes

  • breastfeeding success in white noise group(At the 15th minute of breastfeeding)
  • breastfeeding success in lullaby group(At the 15th minute of breastfeeding)

Study Sites (1)

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