A Study to Assess Virtual Reality by Healthcare Providers to Improve Focus and Reduce Anxiety

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04622527
• Collaborator: Reulay Inc (Other)
• Enrollment: 24
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Burn Out	Other: Random assigned paradigm viewing order	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (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.
• Primary Purpose: Other
• Official Title: Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A = Virtual Reality paradigm A Paradigm A with virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Active Comparator: B = Virtual Reality paradigm B Paradigm B with virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Sham Comparator: C = Non-Virtual Reality paradigm A Paradigm A without virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order
Sham Comparator: D = Non-Virtual Reality paradigm B Paradigm B without virtual reality headgear	Other: Random assigned paradigm viewing order; Participants experience the paradigm in a random order

Outcome Measures

Primary Outcome Measures

1. Acceptability of Virtual Reality [2 weeks]

   Satisfaction survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Reulay Inc

Investigators

• Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic
• Study Director: Brent Bauer, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Ivana Croghan, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04622527
• Other Study ID Numbers: 20-009579
• First Posted: Nov 10, 2020
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ivana Croghan, Principal Investigator, Mayo Clinic: anxiety; burnout
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jan 19, 2022