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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02363179
Other study ID # IRB201500083
Secondary ID 15-8503
Status Completed
Phase N/A
First received February 9, 2015
Last updated July 3, 2017
Start date May 2015
Est. completion date June 2017

Study information

Verified date July 2017
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1107
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States UF Health Gainesville Florida

Sponsors (3)

Lead Sponsor Collaborator
University of Florida Florida Department of State Division Of Cultural Affairs, National Endowment of the Arts

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bengtsson SL, Ullén 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. — View 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. — View 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. — View 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. — View Citation

Rothrock SG, Johnson NE. Pain management in the pediatric emergency department. Pediatr Emerg Care. 1989 Dec;5(4):298. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Medication Utilization Pain Medication Usage 20 weeks
Secondary Cost of Care Assessment of the chart associated cost per patient 20 weeks
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