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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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age: ≥18
  2. Chief complaint of musculoskeletal pain
  3. Gender: Male or Female
  4. Ethnicity: Any
  5. Physical ability: Any
  6. Language: English
  7. Cognitive skill/education: grade 2 reading level or above
  8. Physically and cognitively able to participate in study procedures

Exclusion Criteria:

  1. Patients who are unable to participate in the informed consent process
  2. 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

First Posted
October 26, 2017
Last Updated
March 27, 2020
Sponsor
University of Florida
Collaborators
National Endowment for the Arts, United States
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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

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Music in Urgent and Emergent Settings

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