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

Not Applicable

Completed

• Conditions: Anxiety; Burn Out
• Interventions: Other: Random assigned paradigm viewing order

• Registration Number: NCT04622527
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Results First Submitted: 2022-05-04
• Study Completion: 2022-12-01
• Results First Submitted QC: 2023-02-28
• Status Verified: 2023-12
• Results First Posted: 2023-12-08
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D = Non-Virtual Reality paradigm B	Random assigned paradigm viewing order	Begin with Paradigm B without virtual reality headgear
B = Virtual Reality paradigm B	Random assigned paradigm viewing order	Begin with Paradigm B virtual reality headgear
A = Virtual Reality paradigm A	Random assigned paradigm viewing order	Begin with Paradigm A virtual reality headgear
C = Non-Virtual Reality paradigm A	Random assigned paradigm viewing order	Begin with Paradigm A without virtual reality headgear

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI Y1)	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Was the Study Worthwhile	2 weeks	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?".

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States