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Recruiting NCT07564882

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

Conditions: Congenital Heart Disease (CHD), Chest Tube Removal

Sex: All
Ages: 2 Months – 12 Months
Healthy volunteers: No
Phase: NA
Enrollment: 54
Sponsor: Baskent University

Location: Başkent University Ankara Hospital Ankara

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07564882). StuddyBuddy aggregates publicly available trial information.