Breastfeeding Success in NewbornsNCT07537218
Lullabies and the Effectiveness of White Noise in Breastfeeding
A study testing A Woman's Voice Lullaby, A man's voice singing a lullaby and White Noise in people with Breastfeeding Success in Newborns, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study aims to examine the effect of lullabies and white noise on breastfeeding success in newborns. Method: The study was conducted using a randomized controlled experimental design. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Success in Newborns
- What is being tested?
- A Woman's Voice Lullaby, A man's voice singing a lullaby and White Noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Jul 2019
- 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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 38 and 42 weeks Birth weight between 2,500 and 4,000 grams Apgar scores of 8 or higher at 1 and 5 minutes No anatomical, physiological, congenital, or auditory anomalies No family history of childhood hearing loss Healthy newborns for whom parental consent was obtained
Who cannot join
- Preterm or post-term newborns (gestational age <37 weeks or >42 weeks) Newborns with congenital anomalies or health problems Mothers with hearing impairment Mothers with communication barriers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat State Hospital
Tokat Province, Tokat Province
About this study
Official title: The Effects of Lullabies and White Noise on Breastfeeding Success in Newborns: A Randomized Controlled Trial
Objective: The study aims to examine the effect of lullabies and white noise on breastfeeding success in newborns.
Method: The study was conducted using a randomized controlled experimental design. The sample size, determined based on power analysis, consisted of 160 newborns, and participants were divided into four groups (female voice lullaby=40, male voice lullaby=40, white noise=40, control=40). Infants in the experimental groups were exposed to the relevant auditory stimulus during breastfeeding, while no intervention was made in the control group. Data were collected using the mother and newborn information form and the LATCH Breastfeeding Assessment Scale.
- Conditions
- Breastfeeding Success in Newborns
- Being tested
- A Woman's Voice Lullaby, A man's voice singing a lullaby, White Noise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Woman's Voice LullabyOther
Mircan Kaya - The lullaby "I Set Out on Foot from Çamlıbel" was played at a sound level of 55 dB during the first 15 minutes of breastfeeding.
A man's voice singing a lullabyOther
Kadim Tekin - "I Set Out on Foot from Çamlıbel" lullaby was played at a sound level of 55 dB during the first 15 minutes of breastfeeding.
White NoiseOther
Orhan Osman - Don't Let Your Baby Cry: Two white noise recordings were played at a sound level of 55 dB during the first 15 minutes of breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: | No intervention | Control Group: No auditory stimulus was applied. Mothers and newborns were observed under natural conditions with appropriate breastfeeding positioning. |
| Female Lullaby Group: | Experimental | Female Lullaby Group: Female lullaby (Mircan Kaya - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding. Receives: Other: A Woman's Voice Lullaby |
| Male Lullaby Group: | Experimental | Male Lullaby Group: Male lullaby (Kadim Tekin - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding. Receives: Other: A man's voice singing a lullaby |
| White Noise Group: | Experimental | White Noise Group: White noise (Orhan Osman - Bebeğiniz Ağlamasın 2) was played at 55 dB during the first 15 minutes of breastfeeding. Receives: Other: White Noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Assessment Scale Score
The LATCH scale consists of five subcategories: L (Latching-on), A (Audible swallowing), T (Type of nipple), C (Comfort), and H (Help). Each subcategory is scored on a scale of 0 to 2. The total score ranges from 0 to 10, with a higher score indicating better breastfeeding success.
Measured: Within the first 15 minutes of breastfeeding during the first 24 hours after birth
LATCH Breastfeeding Assessment Tool Score
The LATCH scale consists of 5 components (Latching-on, Audible swallowing, Type of nipple, Comfort, Help) each scored 0-2. Total score ranges from 0 to 10, with higher scores indicating better breastfeeding success.
Measured: Within the first 15 minutes of breastfeeding at 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Dec 2018
- Primary completion1 Feb 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Success in NewbornsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four parallel groups: Control, Female lullaby, Male lullaby, and White noise groups. In all intervention groups, auditory stimuli were applied at 55 dB and evaluated with the LATCH scale during the first 15 minutes of breastfeeding.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESMA KIR, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537218
- Sponsor's protocol ID
- 2018/10-01
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lullabies and White Noise on Breastfeeding Success in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537218
- Acronym / sponsor ID
- 2018/10-01
- Conditions
- Breastfeeding Success in Newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 Apr 2026 (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.
Objective: The study aims to examine the effect of lullabies and white noise on breastfeeding success in newborns.
Method: The study was conducted using a randomized controlled experimental design. The sample size, determined based on power analysis, consisted of 160 newborns, and participants were divided into four groups (female voice lullaby=40, male voice lullaby=40, white noise=40, control=40). Infants in the experimental groups were exposed to the relevant auditory stimulus during breastfeeding, while no intervention was made in the control group. Data were collected using the mother and newborn information form and the LATCH Breastfeeding Assessment Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four parallel groups: Control, Female lullaby, Male lullaby, and White noise groups. In all intervention groups, auditory stimuli were applied at 55 dB and evaluated with the LATCH scale during the first 15 minutes of breastfeeding.
| Arm | Type | Receives |
|---|---|---|
| Control Group: | No intervention | –Control Group: No auditory stimulus was applied. Mothers and newborns were observed under natural conditions with appropriate breastfeeding positioning. |
| Female Lullaby Group: | Experimental | Other: A Woman's Voice LullabyFemale Lullaby Group: Female lullaby (Mircan Kaya - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding. |
| Male Lullaby Group: | Experimental | Other: A man's voice singing a lullabyMale Lullaby Group: Male lullaby (Kadim Tekin - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding. |
| White Noise Group: | Experimental | Other: White NoiseWhite Noise Group: White noise (Orhan Osman - Bebeğiniz Ağlamasın 2) was played at 55 dB during the first 15 minutes of breastfeeding. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age between 38 and 42 weeks Birth weight between 2,500 and 4,000 grams Apgar scores of 8 or higher at 1 and 5 minutes No anatomical, physiological, congenital, or auditory anomalies No family history of childhood hearing loss Healthy newborns for whom parental consent was obtained
Key exclusion criteria (1 listed)
- Preterm or post-term newborns (gestational age <37 weeks or >42 weeks) Newborns with congenital anomalies or health problems Mothers with hearing impairment Mothers with communication barriers
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 |
|---|---|---|
| A Woman's Voice LullabyMircan Kaya - The lullaby "I Set Out on Foot from Çamlıbel" was played at a sound level of 55 dB during the first 15 minutes of breastfeeding. | Other | Female Lullaby Group: |
| A man's voice singing a lullabyKadim Tekin - "I Set Out on Foot from Çamlıbel" lullaby was played at a sound level of 55 dB during the first 15 minutes of breastfeeding. | Other | Male Lullaby Group: |
| White NoiseOrhan Osman - Don't Let Your Baby Cry: Two white noise recordings were played at a sound level of 55 dB during the first 15 minutes of breastfeeding. | Other | White Noise Group: |
Primary outcome
LATCH Breastfeeding Assessment Scale Score
Time frame: Within the first 15 minutes of breastfeeding during the first 24 hours after birth
The LATCH scale consists of five subcategories: L (Latching-on), A (Audible swallowing), T (Type of nipple), C (Comfort), and H (Help). Each subcategory is scored on a scale of 0 to 2. The total score ranges from 0 to 10, with a higher score indicating better breastfeeding success.
LATCH Breastfeeding Assessment Tool Score
Time frame: Within the first 15 minutes of breastfeeding at 24 hours postpartum
The LATCH scale consists of 5 components (Latching-on, Audible swallowing, Type of nipple, Comfort, Help) each scored 0-2. Total score ranges from 0 to 10, with higher scores indicating better breastfeeding success.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding Success in Newborns
Recruiting
Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns
Newborn Pain, Newborn Stress
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 A Woman's Voice Lullaby, A man's voice singing a lullaby and White Noise in people with Breastfeeding Success in Newborns, run by Tokat Gaziosmanpasa 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Assessment Scale Score (time frame: Within the first 15 minutes of breastfeeding during the first 24 hours after birth). The study lists 2 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 17 Apr 2026.