Clinical trial NCT03948984: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anxiety
Pain
Critical Illness
Relaxation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in perceived pain visual analog score
timeFrame: Immediately before and after therapeutic music session (about 20 minutes long)
measure: Change in perceived anxiety visual analog score
timeFrame: Immediately before and after therapeutic music session (about 20 minutes long)
measure: Change in perceived relaxation visual analog scale
timeFrame: Immediately before and after therapeutic music session (about 20 minutes long)
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: After conclusion of therapeutic music session (about 20 minutes)
measure: Patient Perceived Impact
timeFrame: After conclusion of therapeutic music session (about 20 minutes)
measure: Feasibility of Intervention (FIM)
timeFrame: After conclusion of therapeutic music session (about 20 minutes)
measure: Intervention Appropriateness Measure (IAM)
timeFrame: After conclusion of therapeutic music session (about 20 minutes)
measure: Perceived Barriers
timeFrame: After conclusion of therapeutic music session (about 20 minutes)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Joseph J. Schlesinger
role: PRINCIPAL_INVESTIGATOR
References: