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

NCT07468682 | Completed

• 1 other identifier: 25-4T/95
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn Basic Care Training

Keywords

Brahms' lullaby, sponge bath, newborn, comfort

Outcome Measures

Primary Outcomes (1)

• Neonatal Comfort (COMFORTneo Scale Score)

  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.

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

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; Behavioral: Routine Sponge Bath

CONTROL GROUP

EXPERIMENTAL

Newborns in this group receive routine sponge bathing without music in the neonatal intensive care unit.

Behavioral: Routine Sponge Bath

Interventions

Brahms' Lullaby BEHAVIORAL

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.

INTERVENTION GROUP

Routine Sponge Bath BEHAVIORAL

Routine sponge bathing is performed without music in newborns hospitalized in the neonatal intensive care unit as part of standard nursing care.

CONTROL GROUP; INTERVENTION GROUP

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gamze Gocmen: lead

Study Sites (1)

Ege University Faculty of Medicine Hospital

Izmir, İzmir, Turkey (Türkiye)

Location

Study Officials

• Nazan Tuna Oran, Prof. Dr.

  Faculty of Health Sciences, Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ebe

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: April 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)