- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07537218
Lullabies and the Effectiveness of White Noise in Breastfeeding
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tokat Province
-
Tokat Province, Tokat Province, Turkey (Türkiye)
- Tokat State Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018/10-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Breastfeeding Success in Newborns
-
Fortaleza UniversityCompletedOrofacial Difficulties in Newborns | Maternal Breastfeeding in Newborns | Newborns in Rooming-in
-
Selcuk UniversityCompletedMotivation | Breastfeeding | Self-Efficacy | SuccessTurkey
-
Mersin UniversityCompletedHealthy Newborns | Comfort in NeonatesTurkey (Türkiye)
-
Al-Azhar UniversityCompletedAdult Pulpotomy Success in Diabetic PatientsEgypt
-
Hospices Civils de LyonRecruitingEndocrine Disruptors in Newborns and InfantsFrance
-
University of Medicine and Pharmacy at Ho Chi Minh...175 Military hospitalCompletedClinical and Radiographic Success in 6 MonthsVietnam
-
University Hospital, BrestTerminatedClinical and Radiographic Success in 24 MonthsFrance
-
Oregon Research Behavioral Intervention Strategies...National Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingAcademic Support for Black Middle School Student Success in STEM
-
Mongi Slim HospitalCompletedAccuracy of DE and DTF in Prediction of Extubation SuccessTunisia
-
Universidade Federal do Rio de JaneiroMaternidade Escola da UFRJ; Instituto de Puericultura e Pediatria Martagão...Completed
Clinical Trials on A Woman's Voice Lullaby
-
National Yang Ming UniversityRecruiting
-
VA Office of Research and DevelopmentCompleted
-
Izmir Tinaztepe UniversityNot yet recruitingMusic Therapy | Neonatal Intensive Care | Pain Responses
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPreterm InfantUnited States
-
Celal Bayar UniversityNot yet recruitingUnconscious StateTurkey (Türkiye)
-
University of ValenciaUniversitat Politècnica de València; Iniciativa Social Integral; Las NavesNot yet recruitingDepression | Quality of Life | Anxiety | Loneliness
-
Centre d'Etudes et de Recherche pour l'Intensification...Suspended
-
Papa Giovanni XXIII HospitalCompletedLactate Values During Labour in Women Receiving Neuraxial AnaesthesiaItaly
-
Weill Medical College of Cornell UniversityIthaca CollegeNot yet recruitingTransitioning Voice of Transgender and Gender Diverse PeopleUnited States
-
Swiss Tropical & Public Health InstituteInnovations for Poverty ActionCompletedImmunization CoverageGhana