Lullabies and the Effectiveness of White Noise in Breastfeeding

April 12, 2026 updated by: ESMA KIR, Tokat Gaziosmanpasa University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Tokat Province
      • Tokat Province, Tokat Province, Turkey (Türkiye)
        • Tokat State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group:
Control Group: No auditory stimulus was applied. Mothers and newborns were observed under natural conditions with appropriate breastfeeding positioning.
Experimental: Female Lullaby Group:
Female Lullaby Group: Female lullaby (Mircan Kaya - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding.
Other: A Woman's Voice Lullaby
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.
Experimental: Male Lullaby Group:
Male Lullaby Group: Male lullaby (Kadim Tekin - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding.
Other: A man's voice singing a lullaby
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.
Experimental: White Noise Group:
White Noise Group: White noise (Orhan Osman - Bebeğiniz Ağlamasın 2) was played at 55 dB during the first 15 minutes of breastfeeding.
Other: White Noise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within the first 15 minutes of breastfeeding during the first 24 hours after birth
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.
Within the first 15 minutes of breastfeeding at 24 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/10-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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