Augmented Reality Perioperative Training and Patient Satisfaction

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04727697

Collaborator

(none)

120

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety State	Other: Augmented Reality Other: Standard of Care preoperative teaching and handouts	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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: Augmented Reality Patients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes. 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.

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: Augmented Reality

Patients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes.

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.

Outcome Measures

Primary Outcome Measures

Change in Anxiety as measured by the state-trait anxiety inventory (STAI) [Baseline, up to 14 days]
STAI has scores ranging from 20 to 80 with higher scores corresponding to greater levels of anxiety.

Secondary Outcome Measures

Change in comfort level as measured by perioperative comfort questionnaire [Baseline, up to 14 days]
Perioperative comfort questionnaire ranges from 1-5 with higher scores indicating greater levels of comfort.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Lee Kaplan, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lee Kaplan, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04727697

Other Study ID Numbers:

20201439

First Posted:

Jan 27, 2021

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 22, 2022