The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters

NCT07564882 · tracked via the Priya Life Science Turkey tracker

Sponsor

Baskent University

Phase

Not applicable

Started

2026-06-30

Last updated

2026-09-03

Condition(s) studied

Congenital Heart Disease (CHD)Chest Tube Removal

Investigational drug(s) / intervention(s)

Music GroupMusical Mobile Group

Music Group: Soft, slow-tempo instrumental music will be played starting 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure.

Musical Mobile Group: A musical mobile providing audio-visual stimulation (soft, slow-tempo instrumental music with visual movement) will be used starting 10 minutes before the procedure, during, and for 5 minutes after.

Study summary

Chest tube removal in infants undergoing surgery for congenital heart disease is an invasive procedure associated with significant pain and physiological stress responses. This randomized controlled trial evaluates the effects of music and musical mobile interventions on pain and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months are randomly assigned to music, musical mobile, or control groups. Pain is assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation \[SpO₂\]) are monitored. Measurements are obtained at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). The findings aim to support evidence-based non-pharmacological pain management in pediatric intensive care settings.

Eligibility

Sex

ALL

Min age

2 Months

Max age

12 Months

Healthy volunteers

Inclusion Criteria: * Infants aged 2 to 12 months * Undergoing surgery due to congenital heart disease * Having a single chest tube * Not receiving mechanical ventilation support * Parent(s) voluntarily agree to participate in the study Exclusion Criteria: * Receiving mechanical ventilation support * Administration of analgesics within 2 hours prior to chest tube removal * Presence of a neurodevelopmental disorder * Parent(s) do not consent to participate in the study

Primary outcome measure(s)

Pain level assessed by FLACC Scale — [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

Trial sites (1)

Facility	City	Region	Status
Başkent University Ankara Hospital	Ankara	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07564882 on ClinicalTrials.gov ↗ ← All trials in Turkey