A Study to Assess Virtual Reality by Healthcare Providers: A Pilot Study

Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial

The purpose of this study is to evaluate the acceptability of using Virtual Reality intervention to help reduce anxiety and burnout symptoms and improve focus in the workplace.

Study Overview

• Status: Completed
• Conditions: Anxiety; Burn Out
• Intervention / Treatment: Other: Random assigned paradigm viewing order

Detailed Description

The proposed investigation will apply two novel paradigms using proprietary Virtual Reality interventions designed to reduce anxiety and inattention. We will explore whether this intervention is safe and acceptable, and whether it can impact the stress, anxiety, and difficulty in focus of employees in the workplace. Participants will view two different nature videos in two different formats. Each video will be experienced through Virtual Reality or non- Virtual Reality.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older at the time of consent.
• Healthcare Professional with the Mayo Clinic.
• Not pregnant by participant self-report at time of consent.
• Have the ability to provide informed consent.
• Have no contraindicated comorbid health conditions as determined by the clinical investigators.

Exclusion Criteria:

• Currently (within the past 3 weeks) practicing mindfulness training on a weekly/regular basis.
• Currently (within the past 3 weeks) undergoing an additional program (e.g., Complementary and Alternative Medicine [CAM]) to improve quality of life.
• Currently (within 3 weeks) enrolled in another clinical or research program (e.g., CAM) which impacts the patients' quality of life (QOL), stress or anxiety.
• Currently has photosensitivity.
• Cannot tolerate virtual reality experiences.
• An unstable medical or mental health condition as determined by the physician investigator (e.g., pre-existing eye strain, seizures, dizziness, nausea)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A = Virtual Reality paradigm A; Begin with Paradigm A virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Active Comparator: B = Virtual Reality paradigm B; Begin with Paradigm B virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Sham Comparator: C = Non-Virtual Reality paradigm A; Begin with Paradigm A without virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Sham Comparator: D = Non-Virtual Reality paradigm B; Begin with Paradigm B without virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (STAI Y1)	STAI Y1 anxiety measurement of the change from post-test score to pre-test score. The STAI Y1 has 20 questions on a scale from 1 to 4. The minimum score is 20 and the maximum is 80. The lower the score the better the outcome. Our outcome looks at the difference between the post-test from the pre-test, so the minimum change score is -60 and the maximum change score is 60. A higher change in score would mean that a subject experienced a worse outcome after the paradigm, while a lower change in score shows a better outcome after the paradigm than before.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Was the Study Worthwhile	Acceptability of Virtual Reality measured by a question from the satisfaction survey done at the end of the study. The question asked was "Was it worthwhile for you to participate in this research study?".	2 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Reulay Inc
• Investigators: Study Director: Brent Bauer, MD, Mayo Clinic; Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic

Publications and helpful links

General Publications

• Croghan IT, Hurt RT, Aakre CA, Fokken SC, Fischer KM, Lindeen SA, Schroeder DR, Ganesh R, Ghosh K, Bauer BA. Virtual Reality for Health Care Professionals During a Pandemic: A Pilot Program. J Prim Care Community Health. 2022 Jan-Dec;13:21501319221086716. doi: 10.1177/21501319221086716.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: anxiety; burnout
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Burnout, Psychological; Anxiety Disorders
• Other Study ID Numbers: 20-009579

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