## Protocol Section
### Identification Module
**NCT ID:** NCT02363179

**Acronym:** MUES

**Brief Title:** Music in the Emergency Department (ED): Phase II

**Official Title:** Music in Urgent and Emergent Settings (MUES) Trial: Phase Two

#### Organization Study ID Info
**ID:** IRB201500083
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
#### Secondary ID Infos
**Domain:** FL DEPT OF STATE DIV OF CULTURAL AFFAIRS
**ID:** 15-8503
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-07-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05

**Type:** ACTUAL

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2015-02-13
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-09
**Study First Submit QC Date:** 2015-02-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Florida Department of State Division Of Cultural Affairs

**Class:** FED

**Name:** National Endowment for the Arts, United States

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Music Therapy

- Patient Satisfaction

**Keywords:**

- Emergency Service, Hospital

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 1107

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 500 non-intervention patients will be consented to serve as the control group

**Label:** Non Music Group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 500 intervention patients will be consented to participate in the live preferential music intervention

**Intervention Names:**

- Behavioral: Live preferential music

**Label:** Music Intervention Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music Intervention Group

**Description:** Live preferential music will be performed for patients in the emergency department.

**Name:** Live preferential music

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Pain Medication Usage

**Measure:** Pain Medication Utilization

**Time Frame:** 20 weeks

#### Secondary Outcomes

**Description:** Assessment of the chart associated cost per patient

**Measure:** Cost of Care

**Time Frame:** 20 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gainesville

**Country:** United States

**Facility:** UF Health

**State:** Florida

**Zip:** 32608

#### Overall Officials

**Official 1:**

**Affiliation:** University of Florida

**Name:** Joseph A Tyndall, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. No abstract available.

**PMID:** 2602211

**Citation:** 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.

**PMID:** 19041965

**Citation:** 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.

**PMID:** 21600370

**Citation:** Good M. A comparison of the effects of jaw relaxation and music on postoperative pain. Nurs Res. 1995 Jan-Feb;44(1):52-7.

**PMID:** 7862546

**Citation:** 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.

**PMID:** 11168704

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
