Music therapy during pediatric extubation.
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit
See if adding music therapy during extubation helps stabilize vital signs and heart rate variability in children coming off mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | Sanitas University Academic / other |
| Locations | 2 sites (Bogotá, Bogota D.C. and 1 other locations) |
| Trial ID | NCT06591533 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial enrolls pediatric patients undergoing planned extubation at two high-complexity hospitals in Bogotá, Colombia. Participants are randomly assigned to receive standard care with music therapy or to a control group receiving standard care alone during the extubation process. The study continuously records vital signs and heart rate variability around the time of extubation to compare physiologic responses between groups. Results will determine whether music therapy alters immediate physiologic markers linked to stress and potential reintubation risk.
Who should consider this trial
Good fit: Hospitalized pediatric patients who are scheduled for planned extubation from mechanical ventilation at the participating Bogotá hospitals are the intended participants.
Not a fit: Children with accidental extubation (who are excluded) or those who are clinically unstable at the time of extubation may not receive benefit from the intervention.
Why it matters
Potential benefit: If effective, music therapy could reduce stress-related changes in vital signs and heart rate variability during extubation, potentially lowering reintubation risk and improving patient comfort.
How similar studies have performed: Prior studies have shown music therapy can reduce anxiety and stabilize physiologic measures in ventilated adults, but evidence specifically during pediatric extubation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients hospitalized who are undergoing an extubation process. Exclusion Criteria: * Pediatric patients with accidental extubation will be excluded.
Where this trial is running
Bogotá, Bogota D.C. and 1 other locations
- Clínica Reina Sofia Pediátrica y Mujer — Bogotá, Bogota D.C., Colombia (Recruiting)
- Clínica Infantil Santa María del Lago — Bogotá, Bogota D.C., Colombia (Recruiting)
Study contacts
- Study coordinator: Mark Ettenberger, PhD
- Email: mark.ettenberger@gmx.at
- Phone: 57 + 3112847635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.