The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053931
• Other study ID #: Manisa Celal Bayar University
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: January 2024

Study information

• Verified date: September 2023
• Source: Celal Bayar University
• Contact: Asli KARAKUS SELÇUK, PhD
• Phone: +90 0236 233 09 04
• Email: akarakus.ksk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Music
• Newborn

Intervention

Behavioral:
• white noise music
Before the mother starts breastfeeding her baby, white noise music will be turned on to help the baby relax during 2 minutes and during the breastfeeding process, music will be played to the baby and mother for approximately 15 minutes. (https://www.youtube.com/watch?v=5NFHiKMCPvw&t=6478s).
• lullaby music
Before the mother starts breastfeeding her baby, lullaby music will be turned on to help the baby relax during 2 minutes and during the breastfeeding process, music will be played to the baby and mother for approximately 15 minutes. (https://www.youtube.com/watch?v=h0QO8bgysPg)

Locations

Country	Name	City	State
Turkey	Celal Bayar University	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	newborn stress level in white noise group	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.	from pre-intervention to 2 minutes after listening to white noise music.
Primary	newborn stress level in lullaby group	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.	from pre-intervention to 2 minutes after listening to lullaby.
Primary	mother's comfort in white noise group	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.	from pre-intervention to 15 minutes after listening to white noise music
Primary	mother's comfort in lullaby group	Change in mother's comfort from pre-intervention to 15 minutes after listening to lullaby during breastfeeding.	from pre-intervention to 15 minutes after listening to lullaby.
Secondary	breastfeeding success in white noise group	At the 15th minute of breastfeeding in white noise group, breastfeeding success will be evaluated using the LATCH Breastfeeding Assessment Tool.; LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. Each letter of the acronym LATCH denotes an area of assessment. "L" is for how well the infant latches onto the breast. "A" is for the amount of audible swallowing noted. "T" is for the mother's nipple type. "C" is for the mother's level of comfort. "H" is for the amount of help the mother needs to hold her infant to the breast.	At the 15th minute of breastfeeding
Secondary	breastfeeding success in lullaby group	At the 15th minute of breastfeeding in lullaby group, breastfeeding success will be evaluated using the LATCH Breastfeeding Assessment Tool.; LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. Each letter of the acronym LATCH denotes an area of assessment. "L" is for how well the infant latches onto the breast. "A" is for the amount of audible swallowing noted. "T" is for the mother's nipple type. "C" is for the mother's level of comfort. "H" is for the amount of help the mother needs to hold her infant to the breast.	At the 15th minute of breastfeeding