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| Name | Class |
|---|---|
| Relay Therapeutics, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A = Virtual Reality paradigm A | Active Comparator | Begin with Paradigm A virtual reality headgear |
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| B = Virtual Reality paradigm B | Active Comparator | Begin with Paradigm B virtual reality headgear |
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| C = Non-Virtual Reality paradigm A | Sham Comparator | Begin with Paradigm A without virtual reality headgear |
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| D = Non-Virtual Reality paradigm B | Sham Comparator | Begin with Paradigm B without virtual reality headgear |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Random assigned paradigm viewing order | Other | Participants experience the paradigm in a random order |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Was the Study Worthwhile | Acceptability of Virtual Reality measured by a question from the satisfaction survey done at the end of the study. The question asked was "Was it worthwhile for you to participate in this research study?". | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Mayo Clinic | Principal Investigator |
| Brent Bauer, MD | Mayo Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35352605 | Result | 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. |
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The study included a total of 4 treatment interventions to which every participant was exposed. Subjects were randomized to one of the 24 unique treatment sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | A = First Viewing of Virtual Reality Paradigm A | Paradigm A with virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with viewing paradigm A with Virtual Reality headgear. The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| FG001 | B = First Viewing of Virtual Reality Paradigm B | Paradigm B with virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order viewing paradigm B with Virtual Reality headgear. The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| FG002 | C = First Viewing of Non-Virtual Reality Paradigm A | Paradigm A without virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with viewing paradigm A with Computer screen. The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| FG003 | D = First Viewing of Non-Virtual Reality Paradigm B | Paradigm B without virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigm in a random order beginning with viewing paradigm B with Computer screen. The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | A = First Viewing of Virtual Reality Paradigm A | Begin with Paradigm A virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm A with virtual reality headgear The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All 24 subjects experienced each of the 4 virtual reality paradigms. Before and after each paradigm, a STAI Y1 survey was given. The outcomes below shows the change between post and pre for all subjects, no matter what order they viewed the paradigm. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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2 weeks of study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A = Virtual Reality Paradigm A | Paradigm A with virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivana Croghan | Mayo Clinic | 507-284-2511 | gimresearchstudies@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2020 | May 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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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.
| BG001 | B = First Viewing of Virtual Reality Paradigm B | Begin with Paradigm B virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm B with virtual reality headgear The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| BG002 | C = First Viewing of Non-Virtual Reality Paradigm A | Begin with Paradigm A without virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm A through computer screen The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| BG003 | D = First Viewing of Non-Virtual Reality Paradigm B | Begin with Paradigm B without virtual reality headgear Random assigned paradigm viewing order: Participants experience all 4 paradigm in a random order beginning with Paradigm B through computer screen The 4 paradigms are: A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Paradigm A with virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order |
| OG001 | B = Virtual Reality Paradigm B | Paradigm B with virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order |
| OG002 | C = Non-Virtual Reality Paradigm A | Paradigm A without virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order |
| OG003 | D = Non-Virtual Reality Paradigm B | Paradigm B without virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order |
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| Secondary | Was the Study Worthwhile | Acceptability of Virtual Reality measured by a question from the satisfaction survey done at the end of the study. The question asked was "Was it worthwhile for you to participate in this research study?". | Posted | Count of Participants | Participants | 2 weeks |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | B = Virtual Reality Paradigm B | Paradigm B with virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | C = Non-Virtual Reality Paradigm A | Paradigm A without virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | D = Non-Virtual Reality Paradigm B | Paradigm B without virtual reality headgear Random assigned paradigm viewing order: Participants experience the paradigm in a random order | 0 | 24 | 0 | 24 | 0 | 24 |
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| Unsure |
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