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

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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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

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

Conditions
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Music, Breastfeeding, Newborn, Mother

Intervention / Treatment
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* Behavioral: white noise music
* Behavioral: lullaby music


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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<br>* 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)<br>* Other names: lullaby;|
| Experimental: White noise group<br>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<br>* 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).<br>* Other names: white noise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White noise, Lullaby, neonatal stress, comfort