NCT03327077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

October 26, 2017

Last Update Submit

March 27, 2020

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    60 to 90 minutes

Secondary Outcomes (1)

  • Cost of care

    20 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

Music group

Other: Live Preferential Music

Interventions

Live Preferential MusicOTHER

Trained musicians will play live preferential music to ED patients who consent to participate.

Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are unable to participate in the informed consent process
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Tyndall, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

October 31, 2017

Study Start

October 30, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

US(1)