THE EFFECT OF BRAHMS' LULLABY DURING SPONGE BATH ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS (NCT07468682) | Clinical Trial Compass
CompletedNot Applicable
THE EFFECT OF BRAHMS' LULLABY DURING SPONGE BATH ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS
Turkey (Türkiye)70 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
1 Day – 7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neonatal Comfort (COMFORTneo Scale Score)
Timeframe: Before bathing, immediately after bathing, and 15 minutes after bathing.