SleepNCT07127419
Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis
An observational study of Sleep and Newborn, run by Istanbul University - Cerrahpasa.
Trial summary
Sleep in the neonatal period is a fundamental biological requirement for regulating growth, neurodevelopment, and the immune system. However, disruptions in sleep patterns during this period are common among both term and preterm infants. Read more about this study
- Who is it for?
- Ages 26 to 37 weeksHealthy volunteers can take part
- How many people
- 1,415 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2025to 1 Dec 2025
- Phase
- Observational
- 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 26 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: This meta-analysis includes preterm (gestational age 26-37 weeks) neonates who were exposed to music therapy, lullabies, or other sound-based interventions in randomized controlled or quasi-experimental studies.
Who may be able to join
- Premature infants who are clinically stable and between 26 and 37 weeks' gestational age.
- Infants monitored in the neonatal intensive care unit (NICU).
- A music-based intervention
- Sleep outcomes and/or physiological parameters measured.
- Randomised controlled design Full-text studies are available.
Who cannot join
- Non-neonatal infants (aged over 28 days). Term infants (≥37 weeks).
- Non-neonatal age groups
- Only assessing secondary outcomes, such as parental anxiety or caregiver stress
- Case reports, conference abstracts, letters, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Sleep in the neonatal period is a fundamental biological requirement for regulating growth, neurodevelopment, and the immune system. However, disruptions in sleep patterns during this period are common among both term and preterm infants. Preterm infants have a more fragile sleep structure due to incomplete neurological maturation, while term infants may also experience sleep difficulties during the postnatal adaptation process. Improving sleep onset and sleep quality in newborns is crucial for the well-being and quality of life of both the infant and the family.
Read the detailed description
Music therapy-particularly lullabies-has been a traditional approach used for centuries to help infants fall asleep. It is believed that music and lullabies promote relaxation by regulating respiration and heart rate in infants, reducing stress responses, and thereby enhancing sleep quality. In recent years, there has been growing interest in music-based interventions in neonatal intensive care units, as these methods offer non-invasive, easily applicable, and cost-effective alternatives. However, research findings on the effects of music therapy and lullabies on neonatal sleep are varied. Due to the physiological and behavioral differences in preterm infants, their responses to music-based interventions may differ from those of term infants. Therefore, comprehensive evaluations of studies involving both preterm and term neonates are crucial for synthesizing current evidence and guiding healthcare professionals.
The aim of this systematic review and meta-analysis is to evaluate the effects of lullaby and music therapy interventions on sleep quality, sleep duration, and sleep onset latency in both preterm and term neonates, and to provide an up-to-date summary of the existing literature.
- Keywords
- lullaby, music therapy, Sound-Based Interventions, newborn, sleep, preterm, term
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lullaby and/or Music Therapy Group | Other Sound-Based Interventions Group | |
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality in Neonates
- Weight gain Sleep-related indicators: sleep duration, duration of quiet sleep, sleep-wake cycle and brain activity, as measured by aEEG.
Measured: During or within 24 hours after the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Beyazgül, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127419
- Sponsor's protocol ID
- İstanbul Universty Cerrahpaşa
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis
- ClinicalTrials.gov ID
- NCT07127419
- Acronym / sponsor ID
- İstanbul Universty Cerrahpaşa
- Keywords
- lullaby, music therapy, Sound-Based Interventions, newborn, sleep, preterm, term
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,415 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Aug 2025 (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.
Sleep in the neonatal period is a fundamental biological requirement for regulating growth, neurodevelopment, and the immune system. However, disruptions in sleep patterns during this period are common among both term and preterm infants. Preterm infants have a more fragile sleep structure due to incomplete neurological maturation, while term infants may also experience sleep difficulties during the postnatal adaptation process. Improving sleep onset and sleep quality in newborns is crucial for the well-being and quality of life of both the infant and the family.
Detailed description
Music therapy-particularly lullabies-has been a traditional approach used for centuries to help infants fall asleep. It is believed that music and lullabies promote relaxation by regulating respiration and heart rate in infants, reducing stress responses, and thereby enhancing sleep quality. In recent years, there has been growing interest in music-based interventions in neonatal intensive care units, as these methods offer non-invasive, easily applicable, and cost-effective alternatives. However, research findings on the effects of music therapy and lullabies on neonatal sleep are varied. Due to the physiological and behavioral differences in preterm infants, their responses to music-based interventions may differ from those of term infants. Therefore, comprehensive evaluations of studies involving both preterm and term neonates are crucial for synthesizing current evidence and guiding healthcare professionals.
The aim of this systematic review and meta-analysis is to evaluate the effects of lullaby and music therapy interventions on sleep quality, sleep duration, and sleep onset latency in both preterm and term neonates, and to provide an up-to-date summary of the existing literature.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lullaby and/or Music Therapy Group | – | –Other Sound-Based Interventions Group |
| 1 | – | – |
Who may qualify
- Ages
- 26 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This meta-analysis includes preterm (gestational age 26-37 weeks) neonates who were exposed to music therapy, lullabies, or other sound-based interventions in randomized controlled or quasi-experimental studies.
Key inclusion criteria (5 listed)
- Premature infants who are clinically stable and between 26 and 37 weeks' gestational age.
- Infants monitored in the neonatal intensive care unit (NICU).
- A music-based intervention
- Sleep outcomes and/or physiological parameters measured.
- Randomised controlled design Full-text studies are available.
Key exclusion criteria (4 listed)
- Non-neonatal infants (aged over 28 days). Term infants (≥37 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep Quality in Neonates
Time frame: During or within 24 hours after the intervention period
- Weight gain Sleep-related indicators: sleep duration, duration of quiet sleep, sleep-wake cycle and brain activity, as measured by aEEG.
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 17 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Newborn, run by Istanbul University - Cerrahpasa.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Sevgili Beyazgül Beyazgül Sevgi, Yükseklisans (+90 546 920 81 71, svg_hll_byzgl@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality in Neonates (time frame: During or within 24 hours after the intervention period). 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 17 Aug 2025.