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

April 7, 2025 updated by: Joanne Loewy, Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Jennifer Townsend, Master of Music Therapy
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Contact:
        • Principal Investigator:
          • Jennifer Townsend

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toning
Vocal Tonal Holding
Other: Toning
Music therapist will begin gentle breathing and toning on a descending "Ah" vowel to stimulate vibration in the chest and increase awareness of the breath. The patient will be encouraged to join the music therapist as is comfortable
Other: Ocean drum & SOK melody
Ocean drum followed by melody of song of kin
Other: Ocean drum & SOK melody
Music therapist will introduce ocean drum to mimic breathing sounds and will hum the melody of Song of Kin to begin entrainment process. Patient will be invited to join the music therapist in humming as is comfortable
Experimental: SOK
Song of kin with lyric content
Other: SOK
Music therapist will introduce sung lyric content of Song of Kin accompanied on guitar. Patient will be invited to sing with music therapist as is comfortable.
Experimental: Process
Processing of experience
Behavioral: Process
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
Experimental: Holding Harmonic Container
Other: Holding Harmonic Container
Music therapist will provide a holding harmonic container of IM7 - IVM7 and will improvise a repeating melody on "ah" based on the ambient sounds in the patient's immediate environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative Length of Time on Ventilator
Time Frame: average 14 days
average 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Length of Stay in Hospital
Time Frame: average 14 days
average 14 days
Respiration Rate
Time Frame: 15 minute intervals over 30 minute intervention
15 minute intervals over 30 minute intervention
Heart Rate
Time Frame: 15 minute intervals over 30 minute intervention
15 minute intervals over 30 minute intervention
Oxygen Saturation
Time Frame: 15 minute intervals over 30 minute intervention
15 minute intervals over 30 minute intervention
Amount of sedation
Time Frame: 14 days
14 days
Richmond Agitation-Sedation Scale (RASS)
Time Frame: 14 days
RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
14 days
Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame: 14 days
CAM-ICU is a delirium monitoring instrument for ICU patients, scored for two possibilities: CAM-ICU Positive (where delirium is present for a patient) or CAM-ICU Negative (where delirium is not present for a patient).
14 days
Pain score
Time Frame: 14 days
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
14 days
Wong-Baker FACES ® Pain Rating Scale
Time Frame: 14 days
Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)
14 days
ICU length of stay
Time Frame: average 14 days
average 14 days
State-Trait Anxiety Inventory (STAI) (Short Form)
Time Frame: 14 days

To calculate the total STAI score (range 20-80):

  • Reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2, and 4=1;
  • Sum all six scores;
  • Multiply total score by 20/6
  • Scores are interpreted such that a "normal" score is approximately 24-36, Higher score indicates more anxiety
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 18-1079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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