The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music therapy + standard care, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Respiratory Failure, Intensive Care Pediatric. Basic parameters: 1 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Other 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, i - Other 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.
Primary outcome measures
- Heart rate [Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.]
Secondary outcome measures (4)
- Respiratory rate [Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.]
- Oxygen saturation [Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.]
- Blood pressure [Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.]
- Heart rate variability [Time frame: From 5 minutes pre-extubation to 10 minutes post-extubation.]
Eligibility criteria
Inclusion criteria
- Pediatric patients hospitalized who are undergoing an extubation process.
Exclusion criteria
- Pediatric patients with accidental extubation will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Colombia · 2 centers
- Clínica Reina Sofia Pediátrica y Mujer — Bogotá
- Clínica Infantil Santa María del Lago — Bogotá
Publications
- 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. PMID 41263836
Identifiers
NCT: NCT06591533 · INV-MT EXTUBACION