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Completed

NCT Number: NCT03948984

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Critical Illness Disease Attributes Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Relaxation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in perceived pain visual analog score

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

    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).

  2. Change in perceived anxiety visual analog score

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

    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).

  3. Change in perceived relaxation visual analog scale

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

    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 outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: After conclusion of therapeutic music session (about 20 minutes)

    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.

  2. Patient Perceived Impact

    Time frame: After conclusion of therapeutic music session (about 20 minutes)

    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).

  3. Feasibility of Intervention (FIM)

    Time frame: After conclusion of therapeutic music session (about 20 minutes)

    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.

  4. Intervention Appropriateness Measure (IAM)

    Time frame: After conclusion of therapeutic music session (about 20 minutes)

    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.

  5. Perceived Barriers

    Time frame: After conclusion of therapeutic music session (about 20 minutes)

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 14, 2019
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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