Sucking BehaviorNCT04807647
the Effect of White Noise on Sucking and Baby Comfort
A study testing Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player. in people with Sucking Behavior, run by Esra Tanrıverdi at 1 site in Turkey (Türkiye).
Trial summary
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborns in babies aged 34-37 weeks who were fed orally by a full enteral mother in the Neonatal Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Sucking Behavior
- What is being tested?
- Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Feb 2022
- 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 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a birth weight of 1800-3600 g,
- Does not have any anatomical and physiological problems,
- Does not show any signs of disease and does not have any congenital disorder,
- Does not have a congenital or acquired malformation related to hearing
- Families without any disability to breastfeed
- Having parental consent
Who cannot join
- • Gestational age cannot be between 34-37 weeks
- Birth weight not in the range of 1800-3600,
- Having any anatomical and physiological problems
- Any signs of illness and congenital disorder
- Having a congenital or acquired malformation related to hearing
- Families who have any disability to breastfeed
- No parental consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit Eğitim Araştırma Research Hospital
Zonguldak, 67100
About this study
Official title: The Effect of White Noise on Sucking Success and Baby Comfort in Premature Babies
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborns in babies aged 34-37 weeks who were fed orally by a full enteral mother in the Neonatal Intensive Care Unit.
Read the detailed description
The Type and Purpose of the Research
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit.
Place and Time of the Study
The research was conducted in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021.
MATERIAL AND METHOD OF THE RESEARCH
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit.
Research Universe
The universe of the study consisted of newborn babies who were born in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021 and who met the inclusion criteria in the study and the babies who were fed by the mother who passed to the mother's room.
Research Sample Thirty control newborn infants who volunteered to participate in the study and met the inclusion criteria were formed by 30 newborns in the white noise group.
Sampling Selection Criteria
- Gestational age between 34-37 weeks,
- Having a birth weight of 1800-3600 g,
- Does not have any anatomical and physiological problems,
- Does not show any signs of disease and does not have any congenital disorder,
- Does not have a congenital or acquired malformation related to hearing
- Families without any disability to breastfeed
- Having parental consent
Materials and Methods
In this study, babies who were called to feed mothers who started to be fed orally with breast milk after leaving intensive care were selected. Informed consent form, Patient Identification Form and Application Registration Form, Premature Infant Comfort Scale, and LATCH Breastfeeding Diagnostic Measurement Tool were used for parents who accepted to participate in the study. The control group and the intervention group were first told about white noise and how it could affect breastfeeding, and the Informed Volunteer form, the Patient Identification Form and the Application Registration Form were filled. The mother and the baby were given the appropriate position and breastfeeding was initiated. No application was applied to the mother during the first breastfeeding. During the second breastfeeding, 30 neonatal groups were listened to the song "Your Baby Don't Cry" from Orhan OSMAN's album "Kolik". During the second breastfeeding, no music was played to the control group. After the procedure was completed, the data were collected by the researcher using the Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. Then the data will be analyzed in the spss 16.0 package program.
Data Collection Tools
- Introductory Information Form for Mother and Baby
- LATCH Breastfeeding Diagnostic Scale
- Premature Baby Comfort Scale Decibel measuring device
- Orhan Osman's Colic album-Don't Let Your Baby Cry II
- Conditions
- Sucking Behavior
- Being tested
- Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.
- Keywords
- newborn, music, comfort
- Medical subject headings
- Sucking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.Other
white noise will be played while breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| music band | Experimental | The starting person will first talk about white noise and explain how he can direct breastfeeding, and fill the Informed Volunteer Form, Patient Identification Form and Application Registration Form. The mother and baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. During the second breastfeeding, 30 newborn group Orhan OSMAN's "Kolik" album will be played on the music player "Your Baby Don't Cry". After the process is completed, a written response will be received for the data Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. Receives: Other: Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player. |
| control | No intervention | First, the mother will be informed about the study. Then the appropriate position will be given. The informed volunteer form, the Patient Identification Form and the Application Registration Form will be filled. The mother and the baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. No intervention will be applied during the second breastfeeding. After the procedure is completed, a written response will be received with the data Premature Infant Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Diagnostic Measurement Tool
This measurement tool consists of five evaluation items, a combination of the first letters of these items. The item is between 0 and 2 points. The highest score that can be obtained from the scale is ten. The measurement tool does not have a cut-off point and the higher the LATCH score, the better the breastfeeding success is evaluated.If we look at the five criteria, breast retention, Seeing the swallowing movement of the baby, Type of nipple, Comfort of dyeing the mother's breast and nipple, Holding the baby is the position.
Measured: 2-6 month
Secondary outcomes (1)
Premature comfort scale
It was developed to measure the pain and stress levels of 0-18 years old children hospitalized in the intensive care unit.
It is considered as 7 parameters such as Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each group is a 5-point Likert type scored from 1 to 5, from bad to good. Accordingly, the comfort of the baby is interpreted on the total score. According to this score, 35 is the lowest and 7 the highest comfort score. A high score on the scale indicates that the baby's comfort level is low. If the total score received is 17, the cut-off value of the scale is the limit for the baby's comfort level, indicating the need for an intervention to reduce pain.
Measured: 2-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sucking BehaviorStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra Tanrıverdi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra Tanrıverdi, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807647
- Sponsor's protocol ID
- 12102020100153
- Status last verified
- Nov 2021
- First submitted
- 17 Feb 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise on Sucking Success and Baby Comfort in Premature Babies
- ClinicalTrials.gov ID
- NCT04807647
- Acronym / sponsor ID
- 12102020100153
- Conditions
- Sucking Behavior
- Keywords
- newborn, music, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Esra TanrıverdiUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 19 Mar 2021 (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.
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborns in babies aged 34-37 weeks who were fed orally by a full enteral mother in the Neonatal Intensive Care Unit.
Detailed description
The Type and Purpose of the Research
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit.
Place and Time of the Study
The research was conducted in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021.
MATERIAL AND METHOD OF THE RESEARCH
The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit.
Research Universe
The universe of the study consisted of newborn babies who were born in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021 and who met the inclusion criteria in the study and the babies who were fed by the mother who passed to the mother's room.
Research Sample Thirty control newborn infants who volunteered to participate in the study and met the inclusion criteria were formed by 30 newborns in the white noise group.
Sampling Selection Criteria
- Gestational age between 34-37 weeks,
- Having a birth weight of 1800-3600 g,
- Does not have any anatomical and physiological problems,
- Does not show any signs of disease and does not have any congenital disorder,
- Does not have a congenital or acquired malformation related to hearing
- Families without any disability to breastfeed
- Having parental consent
Materials and Methods
In this study, babies who were called to feed mothers who started to be fed orally with breast milk after leaving intensive care were selected. Informed consent form, Patient Identification Form and Application Registration Form, Premature Infant Comfort Scale, and LATCH Breastfeeding Diagnostic Measurement Tool were used for parents who accepted to participate in the study. The control group and the intervention group were first told about white noise and how it could affect breastfeeding, and the Informed Volunteer form, the Patient Identification Form and the Application Registration Form were filled. The mother and the baby were given the appropriate position and breastfeeding was initiated. No application was applied to the mother during the first breastfeeding. During the second breastfeeding, 30 neonatal groups were listened to the song "Your Baby Don't Cry" from Orhan OSMAN's album "Kolik". During the second breastfeeding, no music was played to the control group. After the procedure was completed, the data were collected by the researcher using the Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. Then the data will be analyzed in the spss 16.0 package program.
Data Collection Tools
- Introductory Information Form for Mother and Baby
- LATCH Breastfeeding Diagnostic Scale
- Premature Baby Comfort Scale Decibel measuring device
- Orhan Osman's Colic album-Don't Let Your Baby Cry II
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music band | Experimental | Other: Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.The starting person will first talk about white noise and explain how he can direct breastfeeding, and fill the Informed Volunteer Form, Patient Identification Form and Application Registration Form. The mother and baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. During the second breastfeeding, 30 newborn group Orhan OSMAN's "Kolik" album will be played on the music player "Your Baby Don't Cry". After the process is completed, a written response will be received for the data Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. |
| control | No intervention | –First, the mother will be informed about the study. Then the appropriate position will be given. The informed volunteer form, the Patient Identification Form and the Application Registration Form will be filled. The mother and the baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. No intervention will be applied during the second breastfeeding. After the procedure is completed, a written response will be received with the data Premature Infant Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Having a birth weight of 1800-3600 g,
- Does not have any anatomical and physiological problems,
- Does not show any signs of disease and does not have any congenital disorder,
- Does not have a congenital or acquired malformation related to hearing
- Families without any disability to breastfeed
Key exclusion criteria (7 listed)
- • Gestational age cannot be between 34-37 weeks
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 |
|---|---|---|
| Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.white noise will be played while breastfeeding | Other | music band |
Primary outcome
LATCH Breastfeeding Diagnostic Measurement Tool
Time frame: 2-6 month
This measurement tool consists of five evaluation items, a combination of the first letters of these items. The item is between 0 and 2 points. The highest score that can be obtained from the scale is ten. The measurement tool does not have a cut-off point and the higher the LATCH score, the better the breastfeeding success is evaluated.If we look at the five criteria, breast retention, Seeing the swallowing movement of the baby, Type of nipple, Comfort of dyeing the mother's breast and nipple, Holding the baby is the position.
1 secondary outcome
Premature comfort scale
Time frame: 2-6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. Study protocol
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player. in people with Sucking Behavior, run by Esra Tanrıverdi 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 6 inclusion and 7 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 22 Nov 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LATCH Breastfeeding Diagnostic Measurement Tool (time frame: 2-6 month). 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 22 Nov 2021.