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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring anxiety, burnout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 29, 2020
Last Updated
January 14, 2022
Sponsor
Mayo Clinic
Collaborators
Reulay Inc
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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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