Music in Urgent and Emergent Settings | NCT03327077

Studies
Music in Urgent and Emergent Settings

NCT03327077

Sponsor

University of Florida

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

304Actual

Phase

Not Applicable

Conditions

Musculoskeletal Pain

Interventions

Live Preferential Music

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
15-3800-7018	Other Grant/Funding Number	US National Endowment for the Arts

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2017Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Oct 26, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2020

Last Update Posted Date

Mar 30, 2020Actual

Name	Class
National Endowment for the Arts, United States	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention
Intervention Group	Experimental	Music group	Other: Live Preferential Music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Live Preferential Music	Other	Trained musicians will play live preferential music to ED patients who consent to participate.	Intervention Group

Measure	Description	Time Frame
Pain reduction		60 to 90 minutes

Measure	Description	Time Frame
Cost of care		20 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Tyndall, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unversity of Florida		Gainesville	Florida	32611	United States

Condition Browse Module

MeSH Terms

ID	Term
D059352	Musculoskeletal Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided