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

NCT04622527 | Completed Results

• 1 other identifier: 20-009579
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Burn Out

Keywords

anxiety; burnout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Was the Study Worthwhile

  2 weeks

Study Arms (4)

A = Virtual Reality paradigm A

ACTIVE COMPARATOR

Begin with Paradigm A virtual reality headgear

Other: Random assigned paradigm viewing order

B = Virtual Reality paradigm B

ACTIVE COMPARATOR

Begin with Paradigm B virtual reality headgear

Other: Random assigned paradigm viewing order

C = Non-Virtual Reality paradigm A

SHAM COMPARATOR

Begin with Paradigm A without virtual reality headgear

Other: Random assigned paradigm viewing order

D = Non-Virtual Reality paradigm B

SHAM COMPARATOR

Begin with Paradigm B without virtual reality headgear

Other: Random assigned paradigm viewing order

Interventions

Random assigned paradigm viewing order OTHER

Participants experience the paradigm in a random order

A = Virtual Reality paradigm A; B = Virtual Reality paradigm B; C = Non-Virtual Reality paradigm A; D = Non-Virtual Reality paradigm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Relay Therapeutics, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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. doi: 10.1177/21501319221086716.

  PMID: 35352605 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Ivana Croghan
• Organization: Mayo Clinic

gimresearchstudies@mayo.edu

507-284-2511

Study Officials

• Ivana T Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Brent Bauer, MD

  Mayo Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 10, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 2, 2024
• Results First Posted: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)