NCT06591533 The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
| NCT ID | NCT06591533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claudia Aristizábal |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking. The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia. This study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.
Eligibility Criteria
Inclusion Criteria: * Pediatric patients hospitalized who are undergoing an extubation process. Exclusion Criteria: * Pediatric patients with accidental extubation will be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06591533 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06591533 currently recruiting?
Yes, NCT06591533 is actively recruiting participants. Contact the research team at mark.ettenberger@gmx.at for enrollment information.
Where is the NCT06591533 trial being conducted?
This trial is being conducted at Bogotá, Colombia, Bogotá, Colombia.
Who is sponsoring the NCT06591533 clinical trial?
NCT06591533 is sponsored by Claudia Aristizábal. The trial plans to enroll 82 participants.