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NCT06591533
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.
NA trial testing Music therapy + standard care in Respiratory Failure in 82 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Claudia Aristizábal |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 82 |
| Start date | 1 September 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Colombia |
Drugs / interventions tested
- Music therapy + standard care
- Standard Care (in control arm) — full drug profile →
Conditions studied
- Respiratory Failure — all drugs for Respiratory Failure →
- Intensive Care Pediatric — all drugs for Intensive Care Pediatric →
Sponsor
Claudia Aristizábal
Who can join
Adults 1 Month to 17, any sex, with Respiratory Failure or Intensive Care Pediatric. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Beltrán YM, Charum DP, Zuluaga CA, Vega MA, et al · · 2025 · PMID 41263836 · DOI 10.1136/bmjopen-2024-098251
Verify or expand the search:
- PubMed search for NCT06591533
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Claudia Aristizábal trials
Trials by the same sponsor.
- NCT06577324 — Music Therapy on State Anxiety Levels and Well-being During Chemotherapy · NA · not yet recruiting
- NCT06510153 — Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit · NA · recruiting
- NCT06408064 — The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate · NA · completed
- NCT04645290 — Efficacy of a Multicomponent and Interdisciplinary Intervention on the Care Ability and Burden of Family Caregivers of P · NA · unknown
- NCT03985930 — Non-immersive Virtual Reality for Pediatric Pain Management · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06591533 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Claudia Aristizábal
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06591533.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing