Clinical trial NCT03642002: The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Official title: The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Acute Hypoxemic Respiratory Failure
Acute Hypercapnic Respiratory Failure
Keywords: music therapy
song of kin
music medicine
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Outcomes Assessor will be unfamiliar with desired outcomes
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Cumulative Length of Time on Ventilator
timeFrame: average 14 days
Secondary outcomes:
measure: Cumulative Length of Stay in Hospital
timeFrame: average 14 days
measure: Respiration Rate
timeFrame: 15 minute intervals over 30 minute intervention
measure: Heart Rate
timeFrame: 15 minute intervals over 30 minute intervention
measure: Oxygen Saturation
timeFrame: 15 minute intervals over 30 minute intervention
measure: Amount of sedation
timeFrame: 14 days
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: 14 days
measure: State-Trait Anxiety Inventory (STAI) (Short Form)
timeFrame: 14 days
measure: Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: 14 days
measure: Pain score
timeFrame: 14 days
measure: Wong-Baker FACES ® Pain Rating Scale
timeFrame: 14 days
measure: ICU length of stay
timeFrame: average 14 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne Loewy, DA, LCAT, MT-BC
role: PRINCIPAL_INVESTIGATOR
References:
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