AnxietyNCT03948984
Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients
A study testing Therapeutic Music Session in people with Anxiety and Pain, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pain, Critical Illness
- What is being tested?
- Therapeutic Music Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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
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.
Read the 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
- Being tested
- Therapeutic Music Session
- Medical subject headings
- Anxiety Disorders, Pain, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Music SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Music Session | Experimental | Not described Receives: Behavioral: Therapeutic Music Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Immediately before and after therapeutic music session (about 20 minutes long)
Secondary outcomes (5)
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.
Measured: After conclusion of therapeutic music session (about 20 minutes)
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).
Measured: After conclusion of therapeutic music session (about 20 minutes)
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.
Measured: After conclusion of therapeutic music session (about 20 minutes)
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.
Measured: After conclusion of therapeutic music session (about 20 minutes)
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.
Measured: After conclusion of therapeutic music session (about 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start31 May 2022
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Schlesinger, Vanderbilt University Medical Center
- Investigators
- Joseph J. Schlesinger, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948984
- Sponsor's protocol ID
- 190812
- Status last verified
- Oct 2025
- First submitted
- 6 May 2019
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03948984
- Acronym / sponsor ID
- 190812
- Conditions
- Anxiety, Pain, Critical Illness, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Music Session | Experimental | Behavioral: Therapeutic Music Session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Music SessionThe 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. | Behavioural | Therapeutic Music Session |
Primary outcome
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).
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).
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).
5 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: After conclusion of therapeutic music session (about 20 minutes)
Patient Perceived Impact
Time frame: After conclusion of therapeutic music session (about 20 minutes)
Feasibility of Intervention (FIM)
Time frame: After conclusion of therapeutic music session (about 20 minutes)
Intervention Appropriateness Measure (IAM)
Time frame: After conclusion of therapeutic music session (about 20 minutes)
Perceived Barriers
Time frame: After conclusion of therapeutic music session (about 20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J. Schlesinger principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Music Session in people with Anxiety and Pain, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived pain visual analog score (time frame: Immediately before and after therapeutic music session (about 20 minutes long)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.