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NCT Number: NCT06591533

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

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.

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Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Infantil Santa María del Lago, Bogotá, Bogota D.C., Colombia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients hospitalized who are undergoing an extubation process.

Exclusion criteria

  • Pediatric patients with accidental extubation will be excluded.

Treatment and study plan

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.

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.

Primary outcomes

  1. Heart rate

    Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

    It will be measured through pulse oximetry every minute.

Secondary outcomes

  1. Respiratory rate

    Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

    It will be measured through pulse oximetry every minute.

  2. Oxygen saturation

    Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

    It will be measured through pulse oximetry every minute.

  3. Blood pressure

    Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

    Diastolic, systolic, and mean BP will be measured on the forearm with an age-appropriate cuff, at the level of the brachial artery in the right antecubital fossa, every 5 minutes.

  4. Heart rate variability

    Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.

    It will be measured with the electrocardiogram by standard monitoring.

Study contacts

Contact information is provided by the study sponsor or research team.

Johana Benavides Cruz, MSc

CONTACT

[email protected]

57+601+ 5948650 ext. 5715593

Mark Ettenberger, PhD

CONTACT

[email protected]

57 + 3112847635

Sponsors and collaborators

Lead sponsor

Claudia Aristizábal

Other

Collaborators

  • Sanitas University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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