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NOT YET RECRUITING
NCT07564882
NA

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

Sponsor: Baskent University

View on ClinicalTrials.gov

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.

Official title: The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery

Key Details

Gender

All

Age Range

2 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-04-30

Completion Date

2027-06-30

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.