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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Other: Toning
* Other: Ocean drum & SOK melody
* Other: SOK
* Behavioral: Process
* Other: Holding Harmonic Container


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Outcomes Assessor will be unfamiliar with desired outcomes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toning<br>Vocal Tonal Holding | Other: Toning<br>* 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<br>|
| Other: Ocean drum & SOK melody<br>Ocean drum followed by melody of song of kin | Other: Ocean drum & SOK melody<br>* 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<br>|
| Experimental: SOK<br>Song of kin with lyric content | Other: SOK<br>* 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.<br>|
| Experimental: Process<br>Processing of experience | Behavioral: Process<br>* Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.<br>|
| Experimental: Holding Harmonic Container<br> | Other: Holding Harmonic Container<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Length of Time on Ventilator |  | average 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Length of Stay in Hospital |  | average 14 days | 
| Respiration Rate |  | 15 minute intervals over 30 minute intervention | 
| Heart Rate |  | 15 minute intervals over 30 minute intervention | 
| Oxygen Saturation |  | 15 minute intervals over 30 minute intervention | 
| Amount of sedation |  | 14 days | 
| Richmond Agitation-Sedation Scale (RASS) | RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation. | 14 days | 
| State-Trait Anxiety Inventory (STAI) (Short Form) | 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 | 
| Confusion Assessment Method for the ICU (CAM-ICU) | 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 | 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 | 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 |  | average 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, song of kin, music medicine