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

NCT06591533 | Recruiting

• 1 other identifier: INV-MT EXTUBACION
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Failure; Intensive Care Pediatric

Keywords

vital signs; Pediatric Intensive Care Unit; extubation; music therapy; mechanical ventilation; hear rate

Outcome Measures

Primary Outcomes (1)

• Heart rate

  It will be measured through pulse oximetry every minute.

  From 5 minutes pre-extubation to 10 minutes post-extubation.

Secondary Outcomes (4)

• 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 Arms (2)

Music therapy + standard care

EXPERIMENTAL

Other: Music therapy + standard care

Standard care

OTHER

Other: Standard Care (in control arm)

Interventions

Music therapy + standard care OTHER

In the pre-extubation and extubation phase, the musical characteristics will be based on a slow to medium tempo, simple harmonic structures (e.g., tonic-subdominant movements), fluid melodies, and avoiding large intervals or abrupt changes of tonalities. The musical instruments used will be a classical guitar with nylon strings (Yamaha C-40) and the voice of the music therapist without lyrics or words. In the post-extubation phase, the musical characteristics will be based on a moderate tempo, introducing chord progressions aiming at tension-resolution (e.g., dominant-tonic), and a more rhythmic application of melodic or harmonic material.

Music therapy + standard care

Standard Care (in control arm) OTHER

Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.

Standard care

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients hospitalized who are undergoing an extubation process.

You may not qualify if:

• Pediatric patients with accidental extubation will be excluded.

Sponsors & Collaborators

• Claudia Aristizábal: lead
• Sanitas University: collaborator

Study Sites (2)

Clínica Reina Sofia Pediátrica y Mujer

Bogotá, Bogota D.C., 110121, Colombia

RECRUITING

Clínica Infantil Santa María del Lago

Bogotá, Bogota D.C., 111051, Colombia

RECRUITING

Related Publications (1)

• Beltran YM, Charum DP, Zuluaga CA, Vega MA, Benavides-Cruz J, Amarillo M, Canon E, Alvarez I, Ramirez-Moreno J, Paez L, Garzon MC, Calderon PD, Quintero TC, Moreno J, Ettenberger M. Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol. BMJ Open. 2025 Nov 19;15(11):e098251. doi: 10.1136/bmjopen-2024-098251.

  PMID: 41263836 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Music Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Mark Ettenberger, PhD

CONTACT

57 + 3112847635; mark.ettenberger@gmx.at

Johana Benavides Cruz, MSc

CONTACT

57+601+ 5948650; jbenavidescr@unisanitas.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)