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

September 22, 2023 updated by: Celal Bayar University

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

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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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

Study Overview

Status

Not yet recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Manisa, Turkey
        • Celal Bayar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The women will fill out an descriptive characteristics questionnaire, which include questions such as age, education and employment status, number of pregnancies and children etc. Mothers will be asked to mark before breastfeeding on their comfort on the Visual Analog Scale. The number "0" on the scale indicates that it is not comfortable at all, and the number "10" indicates that the comfort is complete.The baby's stress level will measure with the "Newborn Stress Scale" before breastfeeding. While the mother is breastfeeding her baby, the breastfeeding process will be evaluated by the researcher with the "LATCH Breastfeeding Assessment Tool". Baby's stress level will be evaluated at the 1st minute of breastfeeding with the "Newborn Stress Scale". After the breastfeeding process is completed, the mother will be asked to fill out the "Visual Analog Scale" again to evaluate her comfort.
Experimental: Lullaby group

The women will fill out an descriptive characteristics questionnaire. Mothers will be asked to mark before breastfeeding on their comfort on the scale.

The baby's stress level will measure with the "Newborn Stress Scale" before breastfeeding.

Before the mother starts breastfeeding her baby, lullaby music will be turned on to help the baby relax during 2 minutes.

During the breastfeeding process, music will be played to the baby and mother for approximately 15 minutes.

The baby will be observed by the researcher at the first minute of breastfeeding, and the Newborn Stress Scale will be filled in again.

The LATCH assessment will be done within the first 15 minutes of breastfeeding. After breastfeeding is over, they will be asked to fill in the "Visual Analog Scale" in order to evaluate the comfort of the mother.

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)

Other Names:
  • lullaby
Experimental: White noise group

The women will fill out an descriptive characteristics questionnaire. Mothers will be asked to mark before breastfeeding on their comfort on the scale.

The baby's stress level will measure with the "Newborn Stress Scale" before breastfeeding.

Before the mother starts breastfeeding her baby, white noise music will be turned on to help the baby relax during 2 minutes During the breastfeeding process, music will be played to the baby and mother for approximately 15 minutes.

The baby will be observed by the researcher at the first minute of breastfeeding, and the Newborn Stress Scale will be filled in again.

The LATCH assessment will be done within the first 15 minutes of breastfeeding. After breastfeeding is over, they will be asked to fill in the "Visual Analog Scale" in order to evaluate the comfort of the mother.

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).

Other Names:
  • white noise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from pre-intervention to 2 minutes after listening to white noise music.
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.

from pre-intervention to 2 minutes after listening to lullaby.
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.
from pre-intervention to 15 minutes after listening to white noise music
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.
from pre-intervention to 15 minutes after listening to lullaby.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breastfeeding success in white noise group
Time Frame: At the 15th minute of breastfeeding

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
breastfeeding success in lullaby group
Time Frame: At the 15th minute of breastfeeding

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aslı KARAKUŞ SELÇUK, PhD, Manisa Celâl Bayar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Manisa Celal Bayar University (Other Identifier: 2018-213)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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