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

NCT ID: NCT06053931

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-01-31

Brief Summary

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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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

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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.

Conditions

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Music Breastfeeding Newborn Mother

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 90 mothers and newborns, 30 lullaby, 30 white noise and 30 control groups, will constituted the sample of the study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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/.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

lullaby music

Intervention Type 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)

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.

Group Type EXPERIMENTAL

white noise music

Intervention Type 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).

Interventions

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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).

Intervention Type 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)

Intervention Type BEHAVIORAL

Other Intervention Names

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white noise lullaby

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Celal Bayar University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aslı KARAKUŞ SELÇUK, PhD

Role: PRINCIPAL_INVESTIGATOR

Manisa Celal Bayar University

Locations

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Celal Bayar University

Manisa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Aslı KARAKUŞ SELÇUK, PhD

Role: CONTACT

+90 0236 233 09 04

Other Identifiers

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Manisa Celal Bayar University

Identifier Type: -

Identifier Source: org_study_id

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