Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients: A Pilot, Prospective, Single-center Study of Therapeutic Music
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Change in perceived relaxation visual analog scale
Study Overview
Brief Summary
Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff.
Detailed Description
Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain. The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff. The results of this study will inform clinicians on best practices for redesigning, implementing and evaluating a patient and family focused therapeutic music program in the ICU.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient Inclusion Criteria:
- •Current hospitalization in adult ICU at Vanderbilt University Medical Center
Exclusion Criteria
- •Airborne or special contact isolation
- •Unstable hypotension or bradycardia
- •Pregnancy
- •Current prisoner status
- •The inability to communicate either verbally or in writing in English to complete the therapeutic music evaluations
- •Refusal to participate
- •Family Member Inclusion Criteria
- •Family member of ICU patient
- •Family Member Exclusion Criteria
- •The inability to communicate either verbally or in writing English to complete the therapeutic music evaluations
- •Refusal to participate
- •ICU Clinical Staff Inclusion Criteria
- •ICU clinical staff who are in the patient's room during the music session
- •ICU Clinical Staff Exclusion Criteria
- •Refusal to participate
Arms & Interventions
Therapeutic Music Session
Intervention: Therapeutic Music Session (Behavioral)
Outcomes
Primary Outcomes
Change in perceived relaxation visual analog scale
Time Frame: Immediately before and after therapeutic music session (about 20 minutes long)
Comparison of patient reported perceived relaxation visual analog score using an 11-point numerical rating scale ranging from 0 (not relaxed at all) to 10 (completely relaxed).
Change in perceived anxiety visual analog score
Time Frame: Immediately before and after therapeutic music session (about 20 minutes long)
Comparison of patient reported perceived anxiety visual analog score using an 11-point numerical rating scale ranging from 0 (no anxiety) to 10 (worst possible anxiety).
Change in perceived pain visual analog score
Time Frame: Immediately before and after therapeutic music session (about 20 minutes long)
Comparison of patient reported perceived pain visual analog score using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Secondary Outcomes
- Acceptability of Intervention Measure (AIM)(After conclusion of therapeutic music session (about 20 minutes))
- Intervention Appropriateness Measure (IAM)(After conclusion of therapeutic music session (about 20 minutes))
- Feasibility of Intervention (FIM)(After conclusion of therapeutic music session (about 20 minutes))
- Patient Perceived Impact(After conclusion of therapeutic music session (about 20 minutes))
- Perceived Barriers(After conclusion of therapeutic music session (about 20 minutes))
Investigators
Joseph Schlesinger
Assistant Professor of Anesthesiology
Vanderbilt University Medical Center