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

Not Applicable

Not yet recruiting

• Conditions: Respiratory Failure; Intensive Care Pediatric
• Interventions: Other: Music therapy + standard care; Other: Standard Care (in control arm)

• Registration Number: NCT06591533
• Lead Sponsor: Claudia Aristizábal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Pediatric patients hospitalized who are undergoing an extubation process.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy + standard care	Music therapy + standard care	-
Standard care	Standard Care (in control arm)	-

Primary Outcome Measures

Name	Time	Method
Heart rate	From 5 minutes pre-extubation to 10 minutes post-extubation.	It will be measured through pulse oximetry every minute.

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	From 5 minutes pre-extubation to 10 minutes post-extubation.	It will be measured through pulse oximetry every minute.
Oxygen saturation	From 5 minutes pre-extubation to 10 minutes post-extubation.	It will be measured through pulse oximetry every minute.
Blood pressure	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.
Heart rate variability	From 5 minutes pre-extubation to 10 minutes post-extubation.	It will be measured with the electrocardiogram by standard monitoring.

Trial Locations

Locations (2)

Clínica Reina Sofia Pediátrica y Mujer; 🇨🇴 Bogotá, Bogotá D.C., Colombia

Clínica Infantil Santa María del Lago; 🇨🇴 Bogotá, Bogotá D.C., Colombia