Newborn Basic Care TrainingNCT07468682
THE EFFECT OF BRAHMS' LULLABY DURING SPONGE BATH ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS
A study testing Brahms' Lullaby and Routine Sponge Bath in people with Newborn Basic Care Training, run by Gamze Gocmen at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Newborn Basic Care Training
- What is being tested?
- Brahms' Lullaby and Routine Sponge Bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine Hospital
Izmir, İzmir
About this study
Official title: 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.
- Conditions
- Newborn Basic Care Training
- Being tested
- Brahms' Lullaby, Routine Sponge Bath
- Keywords
- Brahms' lullaby, sponge bath, newborn, comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brahms' LullabyBehavioural
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 BathBehavioural
Routine sponge bathing is performed without music in newborns hospitalized in the neonatal intensive care unit as part of standard nursing care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Sponge Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before bathing, immediately after bathing, and 15 minutes after bathing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Apr 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn Basic Care TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Gocmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gamze Gocmen, Ege University
- Investigators
- Nazan Tuna Oran, Prof. Dr., Principal investigator, Faculty of Health Sciences, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468682
- Sponsor's protocol ID
- 25-4T/95
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF BRAHMS' LULLABY PLAYED DURING SPONGE BATH IN THE NEONATAL INTENSIVE CARE UNIT ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS
- ClinicalTrials.gov ID
- NCT07468682
- Acronym / sponsor ID
- 25-4T/95
- Conditions
- Newborn Basic Care Training
- Keywords
- Brahms' lullaby, sponge bath, newborn, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gamze GocmenUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Behavioral: Brahms' Lullaby, Behavioral: Routine Sponge BathNewborns in this group receive sponge bathing while Brahms' lullaby is played during the bathing procedure in the neonatal intensive care unit. |
| CONTROL GROUP | Experimental | Behavioral: Routine Sponge BathNewborns in this group receive routine sponge bathing without music in the neonatal intensive care unit. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brahms' LullabyBrahms' lullaby is played to newborns during sponge bathing in the neonatal intensive care unit to evaluate its effect on neonatal comfort and physiological parameters. | Behavioural | INTERVENTION GROUP |
| Routine Sponge BathRoutine sponge bathing is performed without music in newborns hospitalized in the neonatal intensive care unit as part of standard nursing care. | Behavioural | CONTROL GROUP, INTERVENTION GROUP |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazan Tuna Oran, Prof. Dr. principal investigator
Faculty of Health Sciences, Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brahms' Lullaby and Routine Sponge Bath in people with Newborn Basic Care Training, run by Gamze Gocmen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Comfort (COMFORTneo Scale Score) (time frame: Before bathing, immediately after bathing, and 15 minutes after bathing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.