Clinical Trial

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

Study acronym: Music Pain Inf
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-15
Trial Details
NCT Number NCT07564882
Lead Sponsor Baskent University
Conditions Congenital Heart Disease (CHD), Chest Tube Removal
Enrollment 54 participants
Start Date 2026-06-30
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-14