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

NCT ID: NCT04622527

Last Updated: 2024-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-01

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.

Conditions

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Anxiety Burn Out

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Virtual Reality headgear and corresponding non-Virtual Reality are pre-programmed with paradigms. Participants were unaware of the order of the experience they will view.

Study Groups

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A = Virtual Reality paradigm A

Begin with Paradigm A virtual reality headgear

Group Type ACTIVE_COMPARATOR

Random assigned paradigm viewing order

Intervention Type OTHER

Participants experience the paradigm in a random order

B = Virtual Reality paradigm B

Begin with Paradigm B virtual reality headgear

Group Type ACTIVE_COMPARATOR

Random assigned paradigm viewing order

Intervention Type OTHER

Participants experience the paradigm in a random order

C = Non-Virtual Reality paradigm A

Begin with Paradigm A without virtual reality headgear

Group Type SHAM_COMPARATOR

Random assigned paradigm viewing order

Intervention Type OTHER

Participants experience the paradigm in a random order

D = Non-Virtual Reality paradigm B

Begin with Paradigm B without virtual reality headgear

Group Type SHAM_COMPARATOR

Random assigned paradigm viewing order

Intervention Type OTHER

Participants experience the paradigm in a random order

Interventions

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Random assigned paradigm viewing order

Participants experience the paradigm in a random order

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Relay Therapeutics, Inc.

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ivana T Croghan, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivana T Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Brent Bauer, MD

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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. doi: 10.1177/21501319221086716.

Reference Type RESULT
PMID: 35352605 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-009579

Identifier Type: -

Identifier Source: org_study_id

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