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

• ClinicalTrials.gov Identifier: NCT06053931
• Recruitment Status: Not yet recruiting
• First Posted: September 26, 2023
• Last Update Posted: September 26, 2023
• Sponsor: Celal Bayar University
• Information provided by (Responsible Party): Celal Bayar University

Study Description

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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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

Condition or disease	Intervention/treatment	Phase
Music; Breastfeeding; Newborn; Mother	Behavioral: white noise music; Behavioral: lullaby music	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A total of 90 mothers and newborns, 30 lullaby, 30 white noise and 30 control groups, will constituted the sample of the study
• Masking: Single (Participant)

Masking Description

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/.

• Primary Purpose: Prevention
• Official Title: The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort During Breastfeeding: a Randomized Controlled Trial
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

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.	Behavioral: 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); Other Name: 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.	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).; Other Name: white noise

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.

2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Aslı KARAKUŞ SELÇUK, PhD; +90 0236 233 09 04; akarakus.ksk@gmail.com

Locations

Turkey

Celal Bayar University

Manisa, Turkey

Sponsors and Collaborators

Celal Bayar University

Investigators

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

More Information

• Responsible Party: Celal Bayar University
• ClinicalTrials.gov Identifier: NCT06053931
• Other Study ID Numbers: Manisa Celal Bayar University
• First Posted: September 26, 2023
• Last Update Posted: September 26, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celal Bayar University:

White noise; Lullaby; neonatal stress; comfort