RecruitingNot ApplicableNCT07564882

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

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

Sponsor

Baskent University

Enrollment

54 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Chest Tube Removal Congenital Heart Disease (CHD)

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

Min Age: 2 MonthsMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Music Group and a behavioral approach called Musical Mobile Group for people with chest tube removal and congenital heart disease (chd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Months to 12 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMusic 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.

BEHAVIORALMusical 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.