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

NCT07564882 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease (CHD)
  • Chest Tube Removal

Interventions

BEHAVIORAL

Music 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.

BEHAVIORAL

Musical 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.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564882 on ClinicalTrials.gov