Music in the NICU: TÜMATA and Mozart to help newborns sleep and feel comfy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this prospective, single-blind, crossover study, newborns in the NICU will experience three conditions—TÜMATA music, Mozart classical music, and routine care—across separate study periods. Sleep duration and comfort will be measured with validated tools at predefined times to compare the effects of the different music types versus standard care. Eligible infants are term, breathing on their own, within 0-28 days old, and admitted to the NICU for at least 24 hours. The study aims to determine if music interventions can improve sleep and comfort in this setting while ensuring safety and parental consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The infant must be in the neonatal period (aged 0-28 days).
* The infant must have been admitted to the Neonatal Intensive Care Unit.
* The infant must have been born at term (38 weeks or more).
* The infant must be breathing spontaneously.
* The infant must have finished feeding at least 30 minutes prior to the procedure.
* The infant must not have received any analgesics and/or sedatives within the last 8 hours.
* The parents must have consented to participate in the study.
* The infant must have been admitted for at least 24 hours.

Exclusion Criteria:

* Newborns readmitted during the data collection period.
* Newborns with respiratory problems.
* Newborns whose parents declined to participate in the study.

Criteria for Withdrawal from the Study:

* A change in the newborn's vital signs.
* The parent's request to withdraw the newborn from the study.

Where it's running

• Karaman Training and Research Hospital
  Karaman, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: hatice dönmez — Karamanoğlu Mehmetbey University
• Study coordinator: Hatice Dönmez, PhD
• Email: hdonmez@kmu.edu.tr
• Phone: +90 0 506 771 58 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.