Augmented Reality Perioperative Training and Patient Satisfaction

NCT04727697 | Completed

• 1 other identifier: 20201439
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in comfort level as measured by perioperative comfort questionnaire

  Baseline, up to 14 days

Study Arms (2)

Standard of Care, preoperative teaching group

ACTIVE COMPARATOR

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

Augmented Reality perioperative experiences group

EXPERIMENTAL

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; Other: Standard of Care preoperative teaching and handouts

Interventions

Augmented Reality OTHER

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

Augmented Reality perioperative experiences group

Standard of Care preoperative teaching and handouts OTHER

At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.

Augmented Reality perioperative experiences group; Standard of Care, preoperative teaching group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 years old or greater
• Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.

  PMID: 37589975 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Lee Kaplan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: May 15, 2021
• Primary Completion: September 22, 2022
• Study Completion: October 4, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)