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NCT06951269
Music Therapy During Hypothermia in the NICU
NA trial testing Live entrained music therapy in Music Therapy in 22 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | Fundación Santa Fe de Bogota |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 30 October 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 1 August 2027 |
| Sites | 1 location across Colombia |
Drugs / interventions tested
- Live entrained music therapy
Conditions studied
- Music Therapy — all drugs for Music Therapy →
- Pain — all drugs for Pain →
- Allodynia — all drugs for Allodynia →
- Neonates — all drugs for Neonates →
Sponsor
Fundación Santa Fe de Bogota — full company profile →
Who can join
Adults 35 Weeks to 44 Weeks, any sex, with Music Therapy or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures. Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings. Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06951269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Music Therapy
Currently open trials in the same condition.
- NCT07398898 — Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients · NA · recruiting
- NCT06939426 — Music Therapy and Humanization in ED Healthcare Professionals · NA · recruiting
- NCT07064733 — Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life · NA · recruiting
- NCT07296731 — Anxiety in Cataract Patients Using Preoperative Music Therapy · NA · active not recruiting
- NCT06970431 — Therapy on Perioperative Anxiety and Pain in Patients · NA · recruiting
Other Fundación Santa Fe de Bogota trials
Trials by the same sponsor.
- NCT06939426 — Music Therapy and Humanization in ED Healthcare Professionals · NA · recruiting
- NCT06118775 — Evaluating Dynamic Arterial Elastance in Septic Shock Patients. · NA · not yet recruiting
- NCT05988853 — Biosafety of Musical Instruments in the ICU · completed
- NCT04571255 — Music Therapy and Pain Management in Burn Patients. · NA · completed
- NCT04654962 — Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Cente · unknown
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 NCT06951269 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Santa Fe de Bogota
- Last refreshed: 23 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/NCT06951269.
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