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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Critical Illness; Anxiety; Relaxation
• Intervention / Treatment: Behavioral: Therapeutic Music Session

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• Current hospitalization in adult ICU at Vanderbilt University Medical Center

Patient 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Music Session	Behavioral: Therapeutic Music Session; The 20 minute therapeutic music session will consist of classical music performed by a pianist with or without flute accompaniment with an individual patient's ICU room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived pain visual analog score	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).	Immediately before and after therapeutic music session (about 20 minutes long)
Change in perceived anxiety visual analog score	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).	Immediately before and after therapeutic music session (about 20 minutes long)
Change in perceived relaxation visual analog scale	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).	Immediately before and after therapeutic music session (about 20 minutes long)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	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.	After conclusion of therapeutic music session (about 20 minutes)
Patient Perceived Impact	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).	After conclusion of therapeutic music session (about 20 minutes)
Feasibility of Intervention (FIM)	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.	After conclusion of therapeutic music session (about 20 minutes)
Intervention Appropriateness Measure (IAM)	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.	After conclusion of therapeutic music session (about 20 minutes)
Perceived Barriers	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.	After conclusion of therapeutic music session (about 20 minutes)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Joseph J. Schlesinger, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 190812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No