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出境医 / 临床实验 / Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients
Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Pain Critical Illness Relaxation | Behavioral: Therapeutic Music Session | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Estimated Study Start Date : | July 1, 2021 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: Therapeutic Music Session |
Behavioral: 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.
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Outcome Measures
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- 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.
- 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).
- 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.
- 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.
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Joseph J. Schlesinger, M.D. | 615-343-6268 | joseph.j.schlesinger@vumc.org | |
| Contact: Gail Mayo | 615-936-1705 | gail.mayo@vumc.org |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
| Principal Investigator: | Joseph J. Schlesinger | Vanderbilt University Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 6, 2019 | ||||||||
| First Posted Date ICMJE | May 14, 2019 | ||||||||
| Last Update Posted Date | August 31, 2020 | ||||||||
| Estimated Study Start Date ICMJE | July 1, 2021 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: 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.
|
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| Study Arms ICMJE | Experimental: Therapeutic Music Session
Intervention: Behavioral: Therapeutic Music Session
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2023 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Family Member Inclusion Criteria
Family Member Exclusion Criteria
ICU Clinical Staff Inclusion Criteria
ICU Clinical Staff Exclusion Criteria
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03948984 | ||||||||
| Other Study ID Numbers ICMJE | 190812 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Joseph Schlesinger, Vanderbilt University Medical Center | ||||||||
| Study Sponsor ICMJE | Vanderbilt University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Vanderbilt University Medical Center | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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