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

Not Applicable

Recruiting

• Conditions: Acute Hypercapnic Respiratory Failure; Acute Respiratory Distress Syndrome; Acute Hypoxemic Respiratory Failure
• Interventions: Other: Toning; Behavioral: Process; Other: Ocean drum & SOK melody; Other: SOK; Other: Holding Harmonic Container

• Registration Number: NCT03642002
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2018-12-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toning	Toning	Vocal Tonal Holding
Process	Process	Processing of experience
Ocean drum & SOK melody	Ocean drum & SOK melody	Ocean drum followed by melody of song of kin
SOK	SOK	Song of kin with lyric content
Holding Harmonic Container	Holding Harmonic Container	-

Primary Outcome Measures

Name	Time	Method
Cumulative Length of Time on Ventilator	average 14 days

Secondary Outcome Measures

Name	Time	Method
Amount of sedation	14 days
Richmond Agitation-Sedation Scale (RASS)	14 days	RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
Heart Rate	15 minute intervals over 30 minute intervention
Oxygen Saturation	15 minute intervals over 30 minute intervention
Pain score	14 days	Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
ICU length of stay	average 14 days
State-Trait Anxiety Inventory (STAI) (Short Form)	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
Respiration Rate	15 minute intervals over 30 minute intervention
Confusion Assessment Method for the ICU (CAM-ICU)	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).
Cumulative Length of Stay in Hospital	average 14 days
Wong-Baker FACES ® Pain Rating Scale	14 days	Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)

Trial Locations

Locations (2)

Mount Sinai West; 🇺🇸 New York, New York, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States