Music in Urgent and Emergent Settings (MUES III)
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Live Preferential Music
Sponsored by
About this trial
This is an interventional health services research trial for Musculoskeletal Pain
Eligibility Criteria
Inclusion Criteria:
- Age: ≥18
- Chief complaint of musculoskeletal pain
- Gender: Male or Female
- Ethnicity: Any
- Physical ability: Any
- Language: English
- Cognitive skill/education: grade 2 reading level or above
- Physically and cognitively able to participate in study procedures
Exclusion Criteria:
- Patients who are unable to participate in the informed consent process
- Prisoners
Sites / Locations
- Unversity of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Music group
Outcomes
Primary Outcome Measures
Pain reduction
Secondary Outcome Measures
Cost of care
Full Information
NCT ID
NCT03327077
First Posted
October 26, 2017
Last Updated
March 27, 2020
Sponsor
University of Florida
Collaborators
National Endowment for the Arts, United States
1. Study Identification
Unique Protocol Identification Number
NCT03327077
Brief Title
Music in Urgent and Emergent Settings
Acronym
MUES III
Official Title
Music in Urgent and Emergent Settings (MUES) Trial: Phase Three
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Endowment for the Arts, United States
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED.
Detailed Description
The purpose of this study is to study the impact of Live Preferential Music on the patient perception of pain and management of pain syndromes in the ED. This study follows a prospective experimental design where patients will be assigned to two groups: one that receives the music intervention and one that does not receive music intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Participant
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Music group
Intervention Type
Other
Intervention Name(s)
Live Preferential Music
Intervention Description
Trained musicians will play live preferential music to ED patients who consent to participate.
Primary Outcome Measure Information:
Title
Pain reduction
Time Frame
60 to 90 minutes
Secondary Outcome Measure Information:
Title
Cost of care
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: ≥18
Chief complaint of musculoskeletal pain
Gender: Male or Female
Ethnicity: Any
Physical ability: Any
Language: English
Cognitive skill/education: grade 2 reading level or above
Physically and cognitively able to participate in study procedures
Exclusion Criteria:
Patients who are unable to participate in the informed consent process
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Tyndall, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Music in Urgent and Emergent Settings
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