Condition: Respiratory Failure · Intensive Care Pediatric · Sponsor: Claudia Aristizábal
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.
This description comes directly from the study's public registry record.
Mark Ettenberger, PhD · 57 + 3112847635 · mark.ettenberger@gmx.at
Johana Benavides Cruz, MSc · 57+601+ 5948650 · jbenavidescr@unisanitas.edu.co
Always discuss trial participation with your own doctor first.
| Clínica Reina Sofia Pediátrica y Mujer | Bogotá, Bogota D.C., Colombia | Recruiting |
| Clínica Infantil Santa María del Lago | Bogotá, Bogota D.C., Colombia | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06591533