A Study to Assess Virtual Reality by Healthcare Providers to Improve Focus and Reduce Anxiety
Primary Purpose
Anxiety, Burn Out
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Random assigned paradigm viewing order
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring anxiety, burnout
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Sham Comparator
Arm Label
A = Virtual Reality paradigm A
B = Virtual Reality paradigm B
C = Non-Virtual Reality paradigm A
D = Non-Virtual Reality paradigm B
Arm Description
Paradigm A with virtual reality headgear
Paradigm B with virtual reality headgear
Paradigm A without virtual reality headgear
Paradigm B without virtual reality headgear
Outcomes
Primary Outcome Measures
Acceptability of Virtual Reality
Satisfaction survey
Secondary Outcome Measures
Full Information
NCT ID
NCT04622527
First Posted
October 29, 2020
Last Updated
January 14, 2022
Sponsor
Mayo Clinic
Collaborators
Reulay Inc
1. Study Identification
Unique Protocol Identification Number
NCT04622527
Brief Title
A Study to Assess Virtual Reality by Healthcare Providers to Improve Focus and Reduce Anxiety
Official Title
Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Reulay Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Burn Out
Keywords
anxiety, burnout
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Virtual Reality headgear and corresponding non-Virtual Reality are pre-programmed with paradigms. Participants will be unaware of the order of the experience they will view.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A = Virtual Reality paradigm A
Arm Type
Active Comparator
Arm Description
Paradigm A with virtual reality headgear
Arm Title
B = Virtual Reality paradigm B
Arm Type
Active Comparator
Arm Description
Paradigm B with virtual reality headgear
Arm Title
C = Non-Virtual Reality paradigm A
Arm Type
Sham Comparator
Arm Description
Paradigm A without virtual reality headgear
Arm Title
D = Non-Virtual Reality paradigm B
Arm Type
Sham Comparator
Arm Description
Paradigm B without virtual reality headgear
Intervention Type
Other
Intervention Name(s)
Random assigned paradigm viewing order
Intervention Description
Participants experience the paradigm in a random order
Primary Outcome Measure Information:
Title
Acceptability of Virtual Reality
Description
Satisfaction survey
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana T Croghan, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brent Bauer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Assess Virtual Reality by Healthcare Providers to Improve Focus and Reduce Anxiety
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