NCT04727697CompletedNot Applicable
Patient Reported Outcomes, Satisfaction, and Understanding Following Orthopaedic Ambulatory Procedures Using Augmented/Virtual Reality as an Education Tool
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Change in Anxiety as measured by the state-trait anxiety inventory (STAI)
Study Overview
Brief Summary
The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients 18 years old or greater
- •Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.
Exclusion Criteria
- •Any patient not scheduled for procedures
- •Cognitively incapacitated
- •Prisoners.
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Outcomes
Primary Outcomes
Change in Anxiety as measured by the state-trait anxiety inventory (STAI)
Time Frame: Baseline, up to 14 days
STAI has scores ranging from 20 to 80 with higher scores corresponding to greater levels of anxiety.
Secondary Outcomes
- Change in comfort level as measured by perioperative comfort questionnaire(Baseline, up to 14 days)
Investigators
Lee Kaplan
Professor
University of Miami
Study Sites (2)
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