Augmented Reality Perioperative Training and Patient Satisfaction

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety State
• Intervention / Treatment: Other: Standard of Care preoperative teaching and handouts; Other: Augmented Reality

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care, preoperative teaching group; The participants in this group will receive the preoperative teaching and handouts as is the current standard of care.	Other: Standard of Care preoperative teaching and handouts; At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.
Experimental: Augmented Reality perioperative experiences group; The participants in this group will receive the preoperative teaching and handouts as is the current standard of care in addition to receiving the augmented reality (AR) perioperative experience.	Other: Standard of Care preoperative teaching and handouts; At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Lee Kaplan, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20201439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No