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出境医 / 临床实验 / The Impact of Receptive Music Therapy in the ICU
The Impact of Receptive Music Therapy in the ICU
Study Description
Brief Summary:
The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Illness | Other: Music Therapy | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 118 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | Patients are assigned to either the intervention or control group based on flipping a coin. |
| Primary Purpose: | Other |
| Official Title: | The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU |
| Actual Study Start Date : | November 26, 2018 |
| Actual Primary Completion Date : | March 30, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Music Therapy Intervention
Receiving one thirty minute music therapy intervention.
|
Other: Music Therapy
Single thirty minute receptive music therapy intervention.
|
|
No Intervention: Usual Care
Receiving usual care for a patient in the ICU during a 30 minute intervention.
|
Outcome Measures
Primary Outcome Measures :
- Change in heart rate [ Time Frame: 30 minutes ]Physiologic Intervention
- Change in respiratory rate [ Time Frame: 30 minutes ]Physiologic Intervention
- Change in Oxygenation [ Time Frame: 30 minutes ]Physiologic Intervention
Secondary Outcome Measures :
- Critical Care Pain Observation Tool (CPOT): Range of 0-8 Includes 2 points for: Facial expression, body movements, muscle tension, compliance with the ventilator/vocalization. Intent is decrease in pain level. [ Time Frame: 30 minutes ]Pain
- RASS: The Richmond Agitation and Sedation Scale (RASS) 0 (Alert and Calm) -1 -5: Drowsy/Unarousable +1-+4 Agitated/Combative Intent is decrease in agitation level [ Time Frame: 30 minutes ]Agitation
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18 years of age or greater
- On a Mechanical Ventilator
Exclusion Criteria:
- Airborne and Special Contact Isolation
- Non English or Spanish Speaking LARs
- Pregnant
- Prisoners
- Brain Dead
- Unstable bradycardia or hypotension
- Patients who have been referred to music therapy with a goal of stimulation.
Contacts and Locations
Locations
| United States, Virginia | |
| Inova Loudoun Hospital | |
| Leesburg, Virginia, United States, 20176 | |
Sponsors and Collaborators
Inova Health Care Services
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | December 19, 2018 | ||||
| First Posted Date ICMJE | April 30, 2019 | ||||
| Last Update Posted Date | February 9, 2021 | ||||
| Actual Study Start Date ICMJE | November 26, 2018 | ||||
| Actual Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT03931733 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Impact of Receptive Music Therapy in the ICU | ||||
| Official Title ICMJE | The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU | ||||
| Brief Summary | The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Masking Description: Patients are assigned to either the intervention or control group based on flipping a coin. Primary Purpose: Other
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| Condition ICMJE | Critical Illness | ||||
| Intervention ICMJE | Other: Music Therapy
Single thirty minute receptive music therapy intervention.
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| Study Arms ICMJE |
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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 | Completed | ||||
| Actual Enrollment ICMJE |
118 | ||||
| Original Estimated Enrollment ICMJE |
172 | ||||
| Actual Study Completion Date ICMJE | March 31, 2020 | ||||
| Actual Primary Completion Date | March 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
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 | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03931733 | ||||
| Other Study ID Numbers ICMJE | 18-3129 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Inova Health Care Services | ||||
| Study Sponsor ICMJE | Inova Health Care Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Inova Health Care Services | ||||
| Verification Date | February 2021 | ||||
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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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