Back to Trials
NCT03642002NARecruiting

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

Icahn School of Medicine at Mount Sinai

Start Date

12/12/2018

Completion Date

12/1/2028

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

Age Range: 18 years to No maximum

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

Interventions

OTHER

Toning

OTHER

Ocean drum & SOK melody

OTHER

SOK

BEHAVIORAL

Process

OTHER

Holding Harmonic Container

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Respiratory Distress SyndromeAcute Hypoxemic Respiratory FailureAcute Hypercapnic Respiratory Failure

Locations

Mount Sinai West

New York, New York 10019

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Houston Methodist Research Institute

Houston, Texas 77030

United States