The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
NCT ID: NCT06591533
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2025-09-01
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Music therapy + standard care
Music therapy + standard care
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
Standard Care (in control arm)
Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.
Interventions
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Music therapy + standard care
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)
Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
17 Years
ALL
No
Sponsors
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Sanitas University
OTHER
Claudia Aristizábal
OTHER
Responsible Party
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Claudia Aristizábal
Director
Locations
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Clínica Reina Sofia Pediátrica y Mujer
Bogotá, Bogota D.C., Colombia
Clínica Infantil Santa María del Lago
Bogotá, Bogota D.C., Colombia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INV-MT EXTUBACION
Identifier Type: -
Identifier Source: org_study_id
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