THE EFFECT OF BRAHMS' LULLABY DURING SPONGE BATH ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS

March 9, 2026 updated by: Gamze Gocmen

THE EFFECT OF BRAHMS' LULLABY PLAYED DURING SPONGE BATH IN THE NEONATAL INTENSIVE CARE UNIT ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS

This study aims to examine the effect of playing Brahms' lullaby during sponge bathing on neonatal comfort and physiological parameters in a neonatal intensive care unit. The main questions this study aims to answer are whether listening to Brahms' lullaby during sponge bathing improves neonatal comfort and stabilizes physiological parameters such as heart rate, respiratory rate, oxygen saturation, and body temperature. Researchers will compare newborns who receive sponge bathing accompanied by Brahms' lullaby with those who receive routine sponge bathing without music. A total of 70 newborns who meet the inclusion criteria will be randomly assigned to either an intervention group or a control group. Newborn comfort will be evaluated using the COMFORTneo Scale, and physiological parameters including heart rate, respiratory rate, oxygen saturation, and body temperature will be recorded before and after bathing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • 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)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye)
        • Ege University Faculty of Medicine 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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newborns whose parents provide written informed consent for participation
  • Gestational age of 37 weeks or more
  • Birth weight ≥2500 grams
  • Postnatal age between 24 hours and 7 days
  • Newborns who will receive their first bath after birth
  • Physiologically stable newborns
  • Presence of spontaneous breathing
  • No skin condition preventing sponge bathing
  • No congenital or acquired hearing impairment
  • Newborns born by spontaneous vaginal delivery or cesarean section

Exclusion Criteria:

  • Use of sedative and/or muscle relaxant medications
  • Newborns receiving mechanical ventilation support
  • Diagnosis of asphyxia
  • Being within the first 72 hours of the postoperative period
  • Impaired skin integrity
  • Presence of cranial hemorrhage or major congenital, chromosomal, or neurological anomalies

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTERVENTION GROUP
Newborns in this group receive sponge bathing while Brahms' lullaby is played during the bathing procedure in the neonatal intensive care unit.
Behavioral: Brahms' Lullaby
Brahms' lullaby is played to newborns during sponge bathing in the neonatal intensive care unit to evaluate its effect on neonatal comfort and physiological parameters.
Behavioral: Routine Sponge Bath
Routine sponge bathing is performed without music in newborns hospitalized in the neonatal intensive care unit as part of standard nursing care.
Experimental: CONTROL GROUP
Newborns in this group receive routine sponge bathing without music in the neonatal intensive care unit.
Behavioral: Routine Sponge Bath
Routine sponge bathing is performed without music in newborns hospitalized in the neonatal intensive care unit as part of standard nursing care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Comfort (COMFORTneo Scale Score)
Time Frame: Before bathing, immediately after bathing, and 15 minutes after bathing.
Neonatal comfort will be assessed using the COMFORTneo Scale before sponge bathing, immediately after bathing, and 15 minutes after bathing.
Before bathing, immediately after bathing, and 15 minutes after bathing.

Collaborators and Investigators

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

Sponsor

Gamze Gocmen

Investigators

  • Principal Investigator: Nazan Tuna Oran, Prof. Dr., Faculty of Health Sciences, Ege 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)

April 15, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-4T/95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional and ethical restrictions.

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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