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

NCT07127419 | Not Yet Recruiting

• 1 other identifier: İstanbul Universty Cerrahpaşa
• Study Type: observational
• Target: 1,415
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sleep; Newborn

Keywords

lullaby; music therapy; Sound-Based Interventions; newborn; sleep; preterm; term

Outcome Measures

Primary Outcomes (1)

• 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.

  During or within 24 hours after the intervention period

Study Arms (2)

Lullaby and/or Music Therapy Group

Other Sound-Based Interventions Group

1

Eligibility Criteria

• Age: 26 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Sevgili Beyazgül Beyazgül Sevgi, Yükseklisans

CONTACT

+90 546 920 81 71; svg_hll_byzgl@outlook.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sevgi Beyazgül

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 17, 2025
• Study Start: August 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08