NCT07537218

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 14, 2026

Last Update Submit

April 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Within the first 15 minutes of breastfeeding at 24 hours postpartum

Study Arms (4)

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.

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.

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.

Other: White Noise

Interventions

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.

Female Lullaby Group:

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.

Male Lullaby Group:

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.

White Noise Group:

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat State Hospital

Tokat Province, Tokat Province, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 14, 2026

First Posted

April 17, 2026

Study Start

December 1, 2018

Primary Completion

February 1, 2019

Study Completion

July 1, 2019

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations