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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
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.
Age
0 - 17 years
Sex
ALL
Healthy Volunteers
No
Clínica Reina Sofia Pediátrica y Mujer
Bogotá, Bogota D.C., Colombia
Clínica Infantil Santa María del Lago
Bogotá, Bogota D.C., Colombia
Start Date
September 1, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
September 24, 2025
82
ESTIMATED participants
Music therapy + standard care
OTHER
Standard Care (in control arm)
OTHER
Lead Sponsor
Claudia Aristizábal
Collaborators
NCT07186933
NCT05686850
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07098611