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

NCT06053931 | Unknown

• 1 other identifier: Manisa Celal Bayar University
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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

Conditions

Music; Breastfeeding; Newborn; Mother

Keywords

White noise; Lullaby; neonatal stress; comfort

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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

• 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 Outcomes (2)

• breastfeeding success in white noise group

  At the 15th minute of breastfeeding

• breastfeeding success in lullaby group

  At the 15th minute of breastfeeding

Study Arms (3)

Control group

NO INTERVENTION

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.

Lullaby group

EXPERIMENTAL

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.

Behavioral: lullaby music

White noise group

EXPERIMENTAL

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.

Behavioral: white noise music

Interventions

white noise music BEHAVIORAL

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).

Also known as: white noise

White noise group

lullaby music BEHAVIORAL

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)

Also known as: lullaby

Lullaby group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Celal Bayar University

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Aslı KARAKUŞ SELÇUK, PhD

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aslı KARAKUŞ SELÇUK, PhD

CONTACT

+90 0236 233 09 04; akarakus.ksk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The population of the research is consisted of mothers who have just given birth and are hospitalized in the obstetrics and gynecology service at Izmir Bakırçay University Çiğli Training and Research Hospital. No sample selection is made in the research, and all mothers who meet the inclusion criteria and accept the research is constituted the sample. Randomization will be provided to newborns and mothers using the simple randomization method according to their protocol numbers and by using the website https://www.randomizer.org/.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 90 mothers and newborns, 30 lullaby, 30 white noise and 30 control groups, will constituted the sample of the study

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)