Neonatal Intensive Care Unit (NICU)NeoMusicNCT07837180
Effects of TUMATA and Mozart Music on Sleep and Comfort in NICU Newborns
A study testing TUMATA Music and Mozart Classical Music in people with Neonatal Intensive Care Unit (NICU), run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of two different types of music played in the neonatal intensive care unit on newborns' sleep and comfort levels. In this prospective, single-blind, crossover randomized controlled trial, newborns will receive TÜMATA music, Mozart classical music, and routine care (control) in… Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intensive Care Unit (NICU)
- What is being tested?
- TUMATA Music and Mozart Classical Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The infant must be in the neonatal period (aged 0-28 days).
- The infant must have been admitted to the Neonatal Intensive Care Unit.
- The infant must have been born at term (38 weeks or more).
- The infant must be breathing spontaneously.
- The infant must have finished feeding at least 30 minutes prior to the procedure.
- The infant must not have received any analgesics and/or sedatives within the last 8 hours.
- The parents must have consented to participate in the study.
- The infant must have been admitted for at least 24 hours.
Who cannot join
- Newborns readmitted during the data collection period.
- Newborns with respiratory problems.
- Newborns whose parents declined to participate in the study.
- Criteria for Withdrawal from the Study:
- A change in the newborn's vital signs.
- The parent's request to withdraw the newborn from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karaman Training and Research Hospital
Karaman
Hatice Dönmez, PhD, +90 5067715841, hdonmez@kmu.edu.tr
About this study
Official title: The Effect of Two Different Types of Music Played in a Neonatal Intensive Care Unit on Newborns' Sleep and Comfort Levels: A Crossover Randomized Controlled Trial
This study aims to evaluate the effects of two different types of music played in the neonatal intensive care unit on newborns' sleep and comfort levels. In this prospective, single-blind, crossover randomized controlled trial, newborns will receive TÜMATA music, Mozart classical music, and routine care (control) in different study periods. Sleep duration and comfort levels will be assessed using validated measurement tools to determine the effectiveness of music interventions in improving newborn comfort and sleep in the neonatal intensive care unit.
Read the detailed description
Sleep disturbances and discomfort are common among newborns admitted to neonatal intensive care units because of environmental stimuli and routine nursing procedures. Music interventions have been suggested as a safe, non-pharmacological approach to promote relaxation and improve neonatal well-being. However, evidence regarding the comparative effects of different types of music on newborn sleep and comfort remains limited.
The aim of this study is to compare the effects of Turkish Music (TÜMATA), Mozart classical music, and routine care on sleep and comfort levels in newborns hospitalized in a neonatal intensive care unit. This study is designed as a prospective, single-blind, crossover randomized controlled trial. Eligible newborns will receive each intervention according to the randomized crossover sequence. Sleep duration and comfort levels will be assessed using validated measurement tools at predetermined time points. The findings of this study are expected to provide evidence regarding the effectiveness of music interventions in supporting sleep and comfort among newborns in neonatal intensive care units.
- Conditions
- Neonatal Intensive Care Unit (NICU)
- Being tested
- TUMATA Music, Mozart Classical Music
- Keywords
- Newborn, Music therapy, Sleep, Comfort, Randomized controlled trial, Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUMATA MusicOther
Pentatonic music recommended by TÜMATA will be played to newborns through a music player during the intervention period.
Mozart Classical MusicOther
Mozart classical music will be played to newborns through a music player during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| TÜMATA Music | Experimental | Within the scope of this study, pentatonic music, as recommended by TÜMATA, will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up. Receives: Other: TUMATA Music |
| Mozart Classical Music | Experimental | Within the scope of this study, Mozart Classical Music will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up. Receives: Other: Mozart Classical Music |
| Routine Care | No intervention | Participants receive routine neonatal intensive care without music intervention. Standard nursing care is provided according to unit protocols. Sleep and comfort are assessed at the same time points as in the music intervention periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep latency
Sleep latency is defined as the time elapsed from the start of the music intervention (minute 0) until the newborn falls asleep. The time will be observed and recorded in minutes by the researcher.
Measured: From the start of the 45-minute music intervention (minute 0) until sleep onset
Total sleep duration
The time elapsed from sleep onset until spontaneous awakening will be observed and recorded in minutes by the researcher.
Measured: From sleep onset until spontaneous awakening
Neonatal comfort level
Newborn Comfort Behavior Scale The Scale (NICS) is a Likert-type scale consisting of six parameters: wakefulness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In addition to determining comfort, the Neonatal Comfort Behavior Scale (NICS) is an assessment tool that includes quantitative rating scales to enable nurses to evaluate the baby's pain and distress. Each item on the scale is scored from 1 to 5. The total score is evaluated. The lowest possible score on the Neonatal Comfort Behavior Scale (NICS) is 6, and the highest is 30. If the total score is between 14 and 30, it indicates that the baby is in pain or distress, is uncomfortable, and requires interventions to provide comfort. Nurses or observers assess infants' pain and distress based on observations using numerical rating scales ranging from 0 to 10. Scores of 4-6 indicate moderate pain and distress, while scores of 7-10 indicate severe pain and distress.
Measured: Immediately before the intervention, at the 10th minute of the intervention, and immediately after the newborn awakens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive Care Unit (NICU)Studies 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
- Crossover
- Model description
- Participants will receive all study interventions according to a randomized crossover sequence. Each newborn will receive TÜMATA music, Mozart classical music, and routine care during separate study periods. Sleep and comfort outcomes will be assessed after each intervention period, allowing within-subject comparison of the interventions
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hatice Dönmez, Karamanoğlu Mehmetbey University
- Investigators
- hatice dönmez, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837180
- Sponsor's protocol ID
- KMU-SBF-HD-3
- Acronym
- NeoMusic
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Types of Music Played in a Neonatal Intensive Care Unit on Newborns' Sleep and Comfort Levels: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07837180
- Acronym / sponsor ID
- NeoMusic / KMU-SBF-HD-3
- Conditions
- Neonatal Intensive Care Unit (NICU)
- Keywords
- Newborn, Music therapy, Sleep, Comfort, Randomized controlled trial, Nursing care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 23 Sep 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 evaluate the effects of two different types of music played in the neonatal intensive care unit on newborns' sleep and comfort levels. In this prospective, single-blind, crossover randomized controlled trial, newborns will receive TÜMATA music, Mozart classical music, and routine care (control) in different study periods. Sleep duration and comfort levels will be assessed using validated measurement tools to determine the effectiveness of music interventions in improving newborn comfort and sleep in the neonatal intensive care unit.
Detailed description
Sleep disturbances and discomfort are common among newborns admitted to neonatal intensive care units because of environmental stimuli and routine nursing procedures. Music interventions have been suggested as a safe, non-pharmacological approach to promote relaxation and improve neonatal well-being. However, evidence regarding the comparative effects of different types of music on newborn sleep and comfort remains limited.
The aim of this study is to compare the effects of Turkish Music (TÜMATA), Mozart classical music, and routine care on sleep and comfort levels in newborns hospitalized in a neonatal intensive care unit. This study is designed as a prospective, single-blind, crossover randomized controlled trial. Eligible newborns will receive each intervention according to the randomized crossover sequence. Sleep duration and comfort levels will be assessed using validated measurement tools at predetermined time points. The findings of this study are expected to provide evidence regarding the effectiveness of music interventions in supporting sleep and comfort among newborns in neonatal intensive care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will receive all study interventions according to a randomized crossover sequence. Each newborn will receive TÜMATA music, Mozart classical music, and routine care during separate study periods. Sleep and comfort outcomes will be assessed after each intervention period, allowing within-subject comparison of the interventions
| Arm | Type | Receives |
|---|---|---|
| TÜMATA Music | Experimental | Other: TUMATA MusicWithin the scope of this study, pentatonic music, as recommended by TÜMATA, will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up. |
| Mozart Classical Music | Experimental | Other: Mozart Classical MusicWithin the scope of this study, Mozart Classical Music will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up. |
| Routine Care | No intervention | –Participants receive routine neonatal intensive care without music intervention. Standard nursing care is provided according to unit protocols. Sleep and comfort are assessed at the same time points as in the music intervention periods. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The infant must be in the neonatal period (aged 0-28 days).
- The infant must have been admitted to the Neonatal Intensive Care Unit.
- The infant must have been born at term (38 weeks or more).
- The infant must be breathing spontaneously.
- The infant must have finished feeding at least 30 minutes prior to the procedure.
Key exclusion criteria (6 listed)
- Newborns readmitted during the data collection period.
- Newborns with respiratory problems.
- Newborns whose parents declined to participate in the study.
- A change in the newborn's vital signs.
- The parent's request to withdraw the newborn from the study.
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 |
|---|---|---|
| TUMATA MusicPentatonic music recommended by TÜMATA will be played to newborns through a music player during the intervention period. | Other | TÜMATA Music |
| Mozart Classical MusicMozart classical music will be played to newborns through a music player during the intervention period. | Other | Mozart Classical Music |
Primary outcome
Sleep latency
Time frame: From the start of the 45-minute music intervention (minute 0) until sleep onset
Sleep latency is defined as the time elapsed from the start of the music intervention (minute 0) until the newborn falls asleep. The time will be observed and recorded in minutes by the researcher.
Total sleep duration
Time frame: From sleep onset until spontaneous awakening
The time elapsed from sleep onset until spontaneous awakening will be observed and recorded in minutes by the researcher.
Neonatal comfort level
Time frame: Immediately before the intervention, at the 10th minute of the intervention, and immediately after the newborn awakens.
Newborn Comfort Behavior Scale The Scale (NICS) is a Likert-type scale consisting of six parameters: wakefulness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In addition to determining comfort, the Neonatal Comfort Behavior Scale (NICS) is an assessment tool that includes quantitative rating scales to enable nurses to evaluate the baby's pain and distress. Each item on the scale is scored from 1 to 5. The total score is evaluated. The lowest possible score on the Neonatal Comfort Behavior Scale (NICS) is 6, and the highest is 30. If the total score is between 14 and 30, it indicates that the baby is in pain or distress, is uncomfortable, and requires interventions to provide comfort. Nurses or observers assess infants' pain and distress based on observations using numerical rating scales ranging from 0 to 10. Scores of 4-6 indicate moderate pain and distress, while scores of 7-10 indicate severe pain and distress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
hatice dönmez principal investigator
Karamanoğlu Mehmetbey 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 TUMATA Music and Mozart Classical Music in people with Neonatal Intensive Care Unit (NICU), run by Karamanoğlu Mehmetbey University 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 8 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: looking for participants now, as of the sponsor's last update on 23 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Dönmez, PhD (+90 0 506 771 58 41, hdonmez@kmu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep latency (time frame: From the start of the 45-minute music intervention (minute 0) until sleep onset). The study lists 3 primary outcomes in all. 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 23 Sep 2026.