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Augmented Reality Perioperative Training and Patient Satisfaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04727697
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Lee Kaplan, University of Miami

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in comfort level as measured by perioperative comfort questionnaire [ Time Frame: Baseline, up to 14 days ]
    Perioperative comfort questionnaire ranges from 1-5 with higher scores indicating greater levels of comfort.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727697


Contacts
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Contact: Michael Rizzo, MD 305-689-1328 michael.rizzo@jhsmiami.org

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Michael Rizzo, MD    305-689-1328    michael.rizzo@jhsmiami.org   
Principal Investigator: Lee Kaplan, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Lee Kaplan, MD University of Miami
More Information
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Responsible Party: Lee Kaplan, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04727697    
Other Study ID Numbers: 20201439
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No