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

Claudia Aristizábal

Status: Enrolling

Conditions: Respiratory Failure; Intensive Care Pediatric

Treatments: Other: Standard Care (in control arm); Other: Music therapy + standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06591533

INV-MT EXTUBACION

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients hospitalized who are undergoing an extubation process.

Exclusion criteria

• Pediatric patients with accidental extubation will be excluded.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Music therapy + standard care

Experimental group

Treatment:

Other: Music therapy + standard care

Standard care

Other group

Treatment:

Other: Standard Care (in control arm)