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

NCT06650189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Premature Neonates

Interventions

OTHER

Music intervention

Recorded music created by a certified music therapist

Sponsors & Collaborators

  • General and Maternity Hospital of Athens Elena Venizelou

    collaborator OTHER

  • Attikon Hospital

    collaborator OTHER

  • University of West Attica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650189 on ClinicalTrials.gov