The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU

Mount Sinai Health System

Status: Enrolling

Conditions: Acute Hypercapnic Respiratory Failure; Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome

Treatments: Other: SOK; Other: Toning; Other: Holding Harmonic Container; Other: Ocean drum & SOK melody; Behavioral: Process

Study type: Interventional

Funder types: Other

Identifiers

NCT03642002

GCO 18-1079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 5 patient groups

Toning

Experimental group

Description:

Vocal Tonal Holding

Treatment:

Other: Toning

Ocean drum & SOK melody

Other group

Description:

Ocean drum followed by melody of song of kin

Treatment:

Other: Ocean drum & SOK melody

SOK

Experimental group

Description:

Song of kin with lyric content

Treatment:

Other: SOK

Process

Experimental group

Description:

Processing of experience

Treatment:

Behavioral: Process

Holding Harmonic Container

Experimental group

Treatment:

Other: Holding Harmonic Container