- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363179
Music in the Emergency Department (ED): Phase II (MUES)
July 3, 2017 updated by: University of Florida
Music in Urgent and Emergent Settings (MUES) Trial: Phase Two
The investigators will conduct a prospective quasi-experimental design study of patients in the University of Florida Health Emergency Department.
Live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Every year, over 130 million patients access emergency care in the US.
Emergency Departments are high stress environments and are one of the significant drivers of high costs in healthcare.
The prevalence of anxiety experienced by patients in the emergency department (ED) is abundant and substantial.
Anxiety negatively affects the patient, the ED healthcare environment, and ED healthcare staff.
Additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff.
The University of Florida (UF) Department of Emergency Medicine, in partnership with the UF Center for Arts in Medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care.
The investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ED and level one trauma center setting.
The project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care.
Study Type
Interventional
Enrollment (Actual)
1107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- UF Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Language: english
- Cognitive skill/education: grade 2 reading level or above
Exclusion Criteria:
- Language: Non-english speaking
- Age: Less than 18
- Cognitive skill/education: lower than grade 2 reading level
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Non Music Group
500 non-intervention patients will be consented to serve as the control group
|
|
|
Experimental: Music Intervention Group
500 intervention patients will be consented to participate in the live preferential music intervention
|
Live preferential music will be performed for patients in the emergency department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Medication Utilization
Time Frame: 20 weeks
|
Pain Medication Usage
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of Care
Time Frame: 20 weeks
|
Assessment of the chart associated cost per patient
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph A Tyndall, MD, University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. No abstract available.
- Bengtsson SL, Ullen F, Ehrsson HH, Hashimoto T, Kito T, Naito E, Forssberg H, Sadato N. Listening to rhythms activates motor and premotor cortices. Cortex. 2009 Jan;45(1):62-71. doi: 10.1016/j.cortex.2008.07.002. Epub 2008 Oct 30.
- Gallagher LM. The role of music therapy in palliative medicine and supportive care. Semin Oncol. 2011 Jun;38(3):403-6. doi: 10.1053/j.seminoncol.2011.03.010.
- Good M. A comparison of the effects of jaw relaxation and music on postoperative pain. Nurs Res. 1995 Jan-Feb;44(1):52-7.
- Good M, Stanton-Hicks M, Grass JA, Anderson GC, Lai HL, Roykulcharoen V, Adler PA. Relaxation and music to reduce postsurgical pain. J Adv Nurs. 2001 Jan;33(2):208-15. doi: 10.1046/j.1365-2648.2001.01655.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
February 9, 2015
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 13, 2015
Study Record Updates
Last Update Posted (Actual)
July 6, 2017
Last Update Submitted That Met QC Criteria
July 3, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201500083
- 15-8503 (Other Grant/Funding Number: FL DEPT OF STATE DIV OF CULTURAL AFFAIRS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.