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

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Therapeutic Music Session

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Music Session

Arm Description

Outcomes

Primary Outcome Measures

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).

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).

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).

Secondary Outcome Measures

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT03948984

First Posted

May 6, 2019

Last Updated

September 20, 2023

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03948984

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 31, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Pain, Critical Illness, Relaxation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic Music Session

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Therapeutic Music Session

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in perceived pain visual analog score

Description

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).

Time Frame

Immediately before and after therapeutic music session (about 20 minutes long)

Title

Change in perceived anxiety visual analog score

Description

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).

Time Frame

Immediately before and after therapeutic music session (about 20 minutes long)

Title

Change in perceived relaxation visual analog scale

Description

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).

Time Frame

Immediately before and after therapeutic music session (about 20 minutes long)

Secondary Outcome Measure Information:

Title

Acceptability of Intervention Measure (AIM)

Description

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.

Time Frame