The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 178
- Locations
- 3
- Primary Endpoint
- Cumulative Length of Time on Ventilator
Study Overview
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.
Detailed Description
The study will include 178 adult patients on mechanical ventilation. These patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. The music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. The primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. Secondary outcomes include: Amount of sedation, Richmond Agitation-Sedation Scale (RASS), delirium and pain score, ICU and hospital length of stay. The researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, ICU and hospital length of stay.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •End of life
- •More than 2 vasopressors
Arms & Interventions
Process
Processing of experience
Intervention: Process (Behavioral)
Holding Harmonic Container
Intervention: Holding Harmonic Container (Other)
Toning
Vocal Tonal Holding
Intervention: Toning (Other)
Ocean drum & SOK melody
Ocean drum followed by melody of song of kin
Intervention: Ocean drum & SOK melody (Other)
SOK
Song of kin with lyric content
Intervention: SOK (Other)
Outcomes
Primary Outcomes
Cumulative Length of Time on Ventilator
Time Frame: average 14 days
Secondary Outcomes
- Heart Rate(15 minute intervals over 30 minute intervention)
- Oxygen Saturation(15 minute intervals over 30 minute intervention)
- Amount of sedation(14 days)
- Richmond Agitation-Sedation Scale (RASS)(14 days)
- Pain score(14 days)
- ICU length of stay(average 14 days)
- State-Trait Anxiety Inventory (STAI) (Short Form)(14 days)
- Respiration Rate(15 minute intervals over 30 minute intervention)
- Confusion Assessment Method for the ICU (CAM-ICU)(14 days)
- Cumulative Length of Stay in Hospital(average 14 days)
- Wong-Baker FACES ® Pain Rating Scale(14 days)
Investigators
Joanne Loewy
Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel
Icahn School of Medicine at Mount Sinai