Skip to main content
Clinical Trials/NCT06591533
NCT06591533
Recruiting
Not Applicable

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

Claudia Aristizábal2 sites in 1 country82 target enrollmentSeptember 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Claudia Aristizábal
Enrollment
82
Locations
2
Primary Endpoint
Heart rate
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
December 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Claudia Aristizábal
Responsible Party
Sponsor Investigator
Principal Investigator

Claudia Aristizábal

Director

Sanitas University

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients hospitalized who are undergoing an extubation process.

Exclusion Criteria

  • Pediatric patients with accidental extubation will be excluded.

Outcomes

Primary Outcomes

Heart rate

Time Frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

It will be measured through pulse oximetry every minute.

Secondary Outcomes

  • Respiratory rate(From 5 minutes pre-extubation to 10 minutes post-extubation.)
  • Oxygen saturation(From 5 minutes pre-extubation to 10 minutes post-extubation.)
  • Blood pressure(From 5 minutes pre-extubation to 10 minutes post-extubation.)
  • Heart rate variability(From 5 minutes pre-extubation to 10 minutes post-extubation.)

Study Sites (2)

Loading locations...

Similar Trials