Augmented Reality Perioperative Training and Patient Satisfaction

Anxiety State Clinical Trial

Official title:

Patient Reported Outcomes, Satisfaction, and Understanding Following Orthopaedic Ambulatory Procedures Using Augmented/Virtual Reality as an Education Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04727697
• Other study ID #: 20201439
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: October 4, 2022

Study information

• Verified date: November 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 4, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Minors
• 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.

Related Conditions & MeSH terms

• Anxiety State

Intervention

Other:
• Augmented Reality
Patients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes.
• Standard of Care preoperative teaching and handouts
At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Anxiety as measured by the state-trait anxiety inventory (STAI)	STAI has scores ranging from 20 to 80 with higher scores corresponding to greater levels of anxiety.	Baseline, up to 14 days
Secondary	Change in comfort level as measured by perioperative comfort questionnaire	Perioperative comfort questionnaire ranges from 1-5 with higher scores indicating greater levels of comfort.	Baseline, up to 14 days