NCT03642002 The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
| NCT ID | NCT03642002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2018-12-12 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2018-12-12 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.
Eligibility 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
Contact & Investigator
Joanne Loewy, DA, LCAT, MT-BC
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT03642002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03642002 currently recruiting?
Yes, NCT03642002 is actively recruiting participants. Contact the research team at joanne.loewy@mountsinai.org for enrollment information.
Where is the NCT03642002 trial being conducted?
This trial is being conducted at New York, United States, Houston, United States, Houston, United States.
Who is sponsoring the NCT03642002 clinical trial?
NCT03642002 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Joanne Loewy, DA, LCAT, MT-BC at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 178 participants.