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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04622527
Other study ID # 20-009579
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2022

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Random assigned paradigm viewing order
Participants experience the paradigm in a random order

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Reulay Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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