Clinical trial NCT06591533: The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure
Intensive Care Pediatric
Keywords: vital signs
Pediatric Intensive Care Unit
extubation
music therapy
mechanical ventilation
hear rate
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Sanitas University
First posted: 2024-09-19
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 or deterioration of the respiratory pattern after extubation that precludes monitoring for 10 minutes post-extubation will be excluded.

Primary outcomes:
measure: Heart rate
timeFrame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Secondary outcomes:
measure: Respiratory rate
timeFrame: From 5 minutes pre-extubation to 10 minutes post-extubation.
measure: Oxygen saturation
timeFrame: From 5 minutes pre-extubation to 10 minutes post-extubation.
measure: Blood pressure
timeFrame: From 5 minutes pre-extubation to 10 minutes post-extubation.
measure: Heart rate variability
timeFrame: From 5 minutes pre-extubation to 10 minutes post-extubation.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Clínica Reina Sofia Pediátrica y Mujer
state: Bogotá D.C.
city: Bogotá
country: Colombia
facility: Clínica Infantil Santa María del Lago
state: Bogotá D.C.
Study officials:
References: