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

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ClinicalTrials.gov Identifier: NCT03948984
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph Schlesinger, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Pain Critical Illness Relaxation Behavioral: Therapeutic Music Session Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Acceptability of Intervention Measure (AIM) [ Time Frame: 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.

  2. Patient Perceived Impact [ Time Frame: 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).

  3. Feasibility of Intervention (FIM) [ Time Frame: 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.

  4. Intervention Appropriateness Measure (IAM) [ Time Frame: 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.

  5. Perceived Barriers [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948984


Contacts
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Contact: Joseph J. Schlesinger, M.D. 615-343-6268 joseph.j.schlesinger@vumc.org
Contact: Gail Mayo 615-936-1705 gail.mayo@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Joseph J. Schlesinger Vanderbilt University Medical Center
More Information
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Responsible Party: Joseph Schlesinger, Assistant Professor of Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03948984    
Other Study ID Numbers: 190812
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes