MusicNCT06053931
The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort
A study testing white noise music and lullaby music in people with Music and Breastfeeding, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music, Breastfeeding, Newborn
- What is being tested?
- white noise music and lullaby music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- mothers who do not agree to participate in the research
- mother has a condition that prevents breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby.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.
Read the 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.
- Conditions
- Music, Breastfeeding, Newborn, Mother
- Being tested
- white noise music, lullaby music
- Keywords
- White noise, Lullaby, neonatal stress, comfort
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white noise musicBehavioural
Also called white noise
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).
lullaby musicBehavioural
Also called lullaby
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: white noise music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: At the 15th minute of breastfeeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslı KARAKUŞ SELÇUK, PhD, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053931
- Sponsor's protocol ID
- Manisa Celal Bayar University
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort During Breastfeeding: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06053931
- Acronym / sponsor ID
- Manisa Celal Bayar University
- Conditions
- Music, Breastfeeding, Newborn, Mother
- Keywords
- White noise, Lullaby, neonatal stress, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: lullaby musicThe 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. |
| White noise group | Experimental | Behavioral: white noise musicThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- mothers who do not agree to participate in the research
- mother has a condition that prevents breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| white noise musicAlso: white noiseBefore 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). | Behavioural | White noise group |
| lullaby musicAlso: lullabyBefore 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) | Behavioural | Lullaby group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
breastfeeding success in white noise group
Time frame: At the 15th minute of breastfeeding
breastfeeding success in lullaby group
Time frame: At the 15th minute of breastfeeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı KARAKUŞ SELÇUK, PhD principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white noise music and lullaby music in people with Music and Breastfeeding, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslı KARAKUŞ SELÇUK, PhD (+90 0236 233 09 04, akarakus.ksk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
newborn stress level in white noise group (time frame: from pre-intervention to 2 minutes after listening to white noise music.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.