The Impact of Receptive Music Therapy in the ICU

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.

Official Title
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The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or greater On a Mechanical Ventilator Exclusion Criteria: Airborne and Special Contact Isolation Non English or Spanish Speaking LARs Pregnant Prisoners Brain Dead Unstable bradycardia or hypotension Patients who have been referred to music therapy with a goal of stimulation.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music Therapy Intervention<br>Receiving one thirty minute music therapy intervention. | Other: Music Therapy<br>* Single thirty minute receptive music therapy intervention.<br>|
| No Intervention: Usual Care<br>Receiving usual care for a patient in the ICU during a 30 minute intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Physiologic Intervention | 30 minutes | 
| Change in respiratory rate | Physiologic Intervention | 30 minutes | 
| Change in Oxygenation | Physiologic Intervention | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical Care Pain Observation Tool (CPOT): Range of 0-8 Includes 2 points for: Facial expression, body movements, muscle tension, compliance with the ventilator/vocalization. Intent is decrease in pain level. | Pain | 30 minutes | 
| RASS: The Richmond Agitation and Sedation Scale (RASS) 0 (Alert and Calm) -1 -5: Drowsy/Unarousable +1-+4 Agitated/Combative Intent is decrease in agitation level | Agitation | 30 minutes |