The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inova Health Care Services
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change in respiratory rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Masking Description
Patients are assigned to either the intervention or control group based on flipping a coin.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Prisoners
- •Brain Dead
- •Unstable bradycardia or hypotension
- •Patients who have been referred to music therapy with a goal of stimulation.
Arms & Interventions
Music Therapy Intervention
Receiving one thirty minute music therapy intervention.
Intervention: Music Therapy (Other)
Usual Care
Receiving usual care for a patient in the ICU during a 30 minute intervention.
Outcomes
Primary Outcomes
Change in respiratory rate
Time Frame: 30 minutes
Physiologic Intervention
Change in Oxygenation
Time Frame: 30 minutes
Physiologic Intervention
Change in heart rate
Time Frame: 30 minutes
Physiologic Intervention
Secondary Outcomes
- 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.(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(30 minutes)