Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03642002

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

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of live entrained music therapy on adult patients requiring mechanical ventilation in the intensive care unit (ICU). This study focuses on patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and acute respiratory distress syndrome (ARDS). The goal is to assess whether live music therapy, tailored to the patient's cultural preferences and synchronized with their vital signs, can reduce the duration of mechanical ventilation and improve related clinical outcomes. The study will enroll 178 adult patients on mechanical ventilation who will be randomly assigned to either a music therapy group or a control group, matched by diagnosis, age, gender, and co-morbidities. The music therapy involves a certified music therapist providing live music using techniques such as vocal toning, ocean drum with song melodies, song of kin with lyrics, processing patient experiences, and creating a harmonic sound environment. These interventions are designed to promote relaxation and comfort through interaction with the patient. Participants will be monitored for various clinical outcomes including the total time spent on mechanical ventilation, amount of sedation given, agitation and sedation levels, delirium, pain scores, and length of ICU and hospital stay. Vital signs such as respiration rate, heart rate, and oxygen saturation will be recorded at 15-minute intervals during the 30-minute music therapy sessions. The study will evaluate these measures over an average period of 14 days. The research aims to understand the impact of music therapy on these important health indicators in ICU patients.

CONDITIONS

Brief 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, or acute respiratory distress syndrome admitted to the ICU requiring mechanical ventilation
  • Patients expected to remain on 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
  • Use of more than 2 vasopressors

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 14 days or until extubation

Participants receive music therapy sessions led by a certified music therapist involving breathing exercises, live music entrainment, and processing of their experience to support comfort while on mechanical ventilation.

Daily sessions during mechanical ventilation

Follow-up

Duration - Up to 14 days after treatment

Participants are monitored for clinical outcomes including sedation levels, agitation, delirium, pain, and length of ICU and hospital stay after the treatment period.

Daily assessments for up to 14 days

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

C

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

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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Published Research Related To This Trial

Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation.

Bryan C Hunter, Rosemary Oliva, Olle Jane Z Sahler...

https://pubmed.ncbi.nlm.nih.gov/21275332

Effects of Music Intervention on State Anxiety and Physiological Indices in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit.

Chiu-Hsiang Lee, Chien-Ying Lee, Ming-Yi Hsu...

https://pubmed.ncbi.nlm.nih.gov/27655993