Clinical Trial

Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)

Study acronym: SONATA
Unknown
View on ClinicalTrials.gov →
Record status
This record was last updated April 1, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins). The main question it aims to answer is: Can the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates? Researchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers. Participants will be exposed to recorded music for 5 consecutive days.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT06650189
Lead Sponsor University of West Attica
Collaborators: General and Maternity Hospital of Athens Elena Venizelou, Attikon Hospital
Conditions Premature Neonates
Enrollment 70 participants
Start Date 2024-07-01
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-01