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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Baskent University • ClinicalTrials.gov ID: NCT07564882

Registry updated: 2026-09-03
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Description

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.

Interventions

  • Music Group (Behavioral)
    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 (Behavioral)
    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.

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

Conditions

Congenital Heart Disease (CHD) Chest Tube Removal

Locations

  • Başkent University Ankara Hospital — Ankara, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record