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NCT Number: NCT07127419

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sevgili Beyazgül Beyazgül Sevgi, Yükseklisans

CONTACT

[email protected]

+90 546 920 81 71

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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