The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-17
SponsorClaudia Aristizábal

About this trial

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

Qualifiers

Pediatric patients hospitalized who are undergoing an extubation process.

Disqualifiers

Pediatric patients with accidental extubation will be excluded.

Trial design

Treatments tested in this trial

  • Music therapy + standard care
  • Standard Care (in control arm)

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Claudia Aristizábal

Lead sponsor

Sanitas University

Sponsor institution

Sanitas University

Collaborator