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

Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03948984
• Other study ID #: 190812
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Pain
• Relaxation

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)