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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Burn Out

Intervention / Treatment
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* Other: Random assigned paradigm viewing order


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants viewed/were exposed to all 4 paradigms but in different sequence according to the randomization. With 4 paradigms there are a total of 24 ordering sequences. With a sample of N=24, each subject was randomized to one of these 24 sequences with each subject having a unique sequence.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, burnout