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

NCT03948984 | Completed

• 1 other identifier: 190812
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Critical Illness; Relaxation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Acceptability of Intervention Measure (AIM)

  After conclusion of therapeutic music session (about 20 minutes)

• Patient Perceived Impact

  After conclusion of therapeutic music session (about 20 minutes)

• Feasibility of Intervention (FIM)

  After conclusion of therapeutic music session (about 20 minutes)

• Intervention Appropriateness Measure (IAM)

  After conclusion of therapeutic music session (about 20 minutes)

• Perceived Barriers

  After conclusion of therapeutic music session (about 20 minutes)

Study Arms (1)

Therapeutic Music Session

EXPERIMENTAL

Behavioral: Therapeutic Music Session

Interventions

Therapeutic Music Session BEHAVIORAL

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.

Therapeutic Music Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current hospitalization in adult ICU at Vanderbilt University Medical Center

You may not qualify if:

• 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 of ICU patient
• The inability to communicate either verbally or in writing English to complete the therapeutic music evaluations
• Refusal to participate
• ICU clinical staff who are in the patient's room during the music session
• Refusal to participate

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Critical Illness

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Joseph J. Schlesinger

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 14, 2019
• Study Start: May 31, 2022
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)