Using music therapy to reduce stress in critically ill patients on mechanical ventilation
Musical Intervention on Stress Effects in Critically Ill Patients
This study is testing if music therapy can help reduce stress in critically ill patients on mechanical ventilation in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oviedo Academic / other |
| Locations | 1 site (Oviedo, Asturias) |
| Trial ID | NCT06120660 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of music therapy on stress-related biomarkers and physiological parameters in sedated patients undergoing invasive mechanical ventilation in an ICU setting. The study involves a randomized design where participants are divided into an intervention group receiving music therapy and a control group receiving standard care. Key variables measured include serum cortisol, prolactin, interleukin-6 levels, and various physiological parameters to assess hemodynamic status. Data will be collected before, during, and after the intervention to determine the effectiveness of music therapy in this population.
Who should consider this trial
Good fit: Ideal candidates are adults who are intubated, sedated, and undergoing invasive mechanical ventilation in the ICU.
Not a fit: Patients with severe neurological or psychiatric conditions, hearing impairments, or those expected to die within 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stress and improve physiological outcomes in critically ill patients.
How similar studies have performed: Previous studies have shown promising results for music therapy in reducing anxiety and stress in various patient populations, suggesting potential success for this approach in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults * Admitted to the ICU for a minimum of 24 hours * Intubated patients undergoing invasive mechanical ventilation * Arterial catheter carriers / central venous catheter * Sedation level: BIS: 40 - 60 * No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale * Not having previously undergone any other musical intervention. Exclusion Criteria: * Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.) * Severe psychiatric illness * Suspected or confirmed drug or alcohol overdose/intoxication/abstinence * Hearing impairment * Skull lesions that preclude the use of headphones * Patients with limitation of therapeutic effort or death expected within 24 hours * Brain death diagnosis * Failure to obtain informed consent from the legal representative within 72 hours of presentation * Refusal of the responsible physician.
Where this trial is running
Oviedo, Asturias
- Hospital Universitario Central de Asturias — Oviedo, Asturias, Spain (Recruiting)
Study contacts
- Principal investigator: Alba Maestro-González, Ph.D. — University of Oviedo
- Study coordinator: Alba Maestro-González, Ph.D.
- Email: maestroalba@uniovi.es
- Phone: +34662186658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.