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

NCT ID: NCT03948984

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2025-02-02

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.

Conditions

Anxiety; Pain; Critical Illness; Relaxation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Therapeutic Music Session

Group Type: EXPERIMENTAL

Therapeutic Music Session

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current hospitalization in adult ICU at Vanderbilt University Medical Center

• Family member of ICU patient

• ICU clinical staff who are in the patient's room during the music session

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

• The inability to communicate either verbally or in writing English to complete the therapeutic music evaluations
• Refusal to participate

• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Schlesinger

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph J. Schlesinger

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

190812

Identifier Type: -

Identifier Source: org_study_id