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Completed

NCT Number: NCT07468682

THE EFFECT OF BRAHMS' LULLABY DURING SPONGE BATH 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.

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Key information

Conditions

Newborn Basic Care Training

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine Hospital

Izmir, İzmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gamze Gocmen

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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