Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03642002

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-09

178

Participants Needed

3

Research Sites

520 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
  • Patients anticipated to need invasive mechanical ventilation for 48 hours or more
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Identified hearing disorder
  • Prior history of chronic respiratory failure requiring mechanical ventilation
  • Richmond Agitation-Sedation Scale (RASS) score of -4 or -5
  • Active seizures or status epilepticus
  • Cardiac arrest
  • Coma
  • End of life status
  • Receiving more than 2 vasopressors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

2

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

3

Houston Methodist Research Institute

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

Joanne Loewy, DA, LCAT, MT-BC

CONTACT

C

Christopher Pizzute, MA, LCAT-LP, MT-BC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

5

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