Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis

August 11, 2025 updated by: Sevgi Beyazgül, Istanbul University - Cerrahpasa
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Lullaby and/or Music Therapy Group
Other Sound-Based Interventions Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During or within 24 hours after the intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 1, 2025

First Submitted That Met QC Criteria

August 11, 2025

First Posted (Actual)

August 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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