Effects of music therapy on ICU patients on mechanical ventilation
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
This study is testing if live music therapy can help ICU patients on mechanical ventilation breathe easier and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT03642002 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of live music therapy on adult patients requiring mechanical ventilation in the ICU. It involves 178 patients who will be randomly assigned to either a music therapy group or a control group, with careful matching based on diagnosis, co-morbidities, age, and gender. The music therapy will be tailored to each patient's cultural preferences and will focus on promoting relaxation and comfort through a certified music therapist. The primary goal is to reduce the duration of mechanical ventilation by 35% compared to the control group, while also assessing secondary outcomes such as sedation levels and ICU length of stay.
Who should consider this trial
Good fit: Ideal candidates are adult patients with acute respiratory distress syndrome or acute respiratory failure who are expected to require mechanical ventilation for at least 48 hours.
Not a fit: Patients under 18 years of age, those with hearing disorders, or those with severe comorbidities such as active seizures or cardiac arrest may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the duration of mechanical ventilation and improve overall patient comfort and recovery in the ICU.
How similar studies have performed: While music therapy has shown promise in reducing anxiety and pain in various settings, this specific approach of entrained live music therapy in mechanically ventilated ICU patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation * Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study Exclusion Criteria: * Under 18 years of age * Identified hearing disorder * Prior history of chronic respiratory failure requiring mechanical ventilation * RASS score of -4, or -5 * Active seizures, or status epilepticus * Cardiac arrest * Coma * End of life * More than 2 vasopressors
Where this trial is running
New York, New York and 2 other locations
- Mount Sinai West — New York, New York, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Joanne Loewy, DA, LCAT, MT-BC — Icahn School of Medicine at Mount Sinai
- Study coordinator: Joanne Loewy, DA, LCAT, MT-BC
- Email: joanne.loewy@mountsinai.org
- Phone: (212) 420-3484
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.