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

Study acronym: Music Pain Inf
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Recruitment opened
    • Start date: Apr 30, 2026 to Jun 30, 2026
    • Study sites: 0 to 1
    v3
  3. Eligibility criteria shortened, about 15 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description shortened, about 26 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07564882
Lead Sponsor Baskent University
Conditions
(from sponsor)		 Congenital Heart Disease (CHD), Chest Tube Removal
Related terms Heart Defects, Congenital
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov