Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients

Not Applicable

• Conditions: Critical Illness; Relaxation; Anxiety; Pain
• Interventions: Behavioral: Therapeutic Music Session

• Registration Number: NCT03948984
• Lead Sponsor: Vanderbilt University Medical Center

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.

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: 2019-05-06
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2022-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Current hospitalization in adult ICU at Vanderbilt University Medical Center

Patient

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapeutic Music Session	Therapeutic Music Session	-

Primary Outcome Measures

Name	Time	Method
Change in perceived relaxation visual analog scale	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	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	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 Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure (AIM)	After conclusion of therapeutic music session (about 20 minutes)	Assessment of acceptability of therapeutic music session using the AIM which is a 4-item survey where each item is scored on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total AIM scores indicate greater implementability. This assessment will be completed by patients, family members, and ICU clinical staff.
Intervention Appropriateness Measure (IAM)	After conclusion of therapeutic music session (about 20 minutes)	Assessment of appropriateness of therapeutic music session using the IAM which is a 4-item survey where each item is scored on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total AIM scores indicate greater implementability. This assessment will be completed by ICU clinical staff.
Feasibility of Intervention (FIM)	After conclusion of therapeutic music session (about 20 minutes)	ICU clinical staff perceived feasibility of therapeutic music session intervention will be assessed with the FIM, a 4-item, 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Higher total scores indicate greater feasibility.
Patient Perceived Impact	After conclusion of therapeutic music session (about 20 minutes)	Patient and family member perceived impact will be assessed using the Patient Music Evaluation Form. Patient and family member participants will complete this 2-item word choice question form to assess how live music made them feel (26 word choices offered eg., happy, sad, hopeful, energized) and whether the music performance made them do anything (20 word choices offered eg., laugh, smile, sing).
Perceived Barriers	After conclusion of therapeutic music session (about 20 minutes)	Perceived barriers will be assessed using qualitative analysis of a 2-item multiple response option and open-ended questions asking for feedback about facilitation and barriers to implementation of therapeutic music in ICU.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States