Anxiety, Burn Out
Conditions
Keywords
anxiety, burnout
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.
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 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.
Interventions
OTHERRandom assigned paradigm viewing order
Participants experience the paradigm in a random order
Sponsors
Relay Therapeutics, Inc.
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI Y1) | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Was the Study Worthwhile | 2 weeks | 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?. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 6 |
| 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 | 6 |
| 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 | 6 |
| Total | 24 |
Baseline characteristics
| Characteristic | B = First Viewing of Virtual Reality Paradigm B | C = First Viewing of Non-Virtual Reality Paradigm A | D = First Viewing of Non-Virtual Reality Paradigm B | Total | A = First Viewing of Virtual Reality Paradigm A |
|---|---|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 5.2 | 49.0 years STANDARD_DEVIATION 15.2 | 45.7 years STANDARD_DEVIATION 12.5 | 46.3 years STANDARD_DEVIATION 10.5 | 48.0 years STANDARD_DEVIATION 7.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 4 Participants | 16 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 3 Participants | 14 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A = Virtual Reality Paradigm A | State-Trait Anxiety Inventory (STAI Y1) | -6.4 units on a scale | Standard Deviation 5.98 |
| B = Virtual Reality Paradigm B | State-Trait Anxiety Inventory (STAI Y1) | -5.8 units on a scale | Standard Deviation 9.29 |
| C = Non-Virtual Reality Paradigm A | State-Trait Anxiety Inventory (STAI Y1) | -4.1 units on a scale | Standard Deviation 6.22 |
| D = Non-Virtual Reality Paradigm B | State-Trait Anxiety Inventory (STAI Y1) | -5.0 units on a scale | Standard Deviation 6.89 |
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?.
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A = Virtual Reality Paradigm A | Was the Study Worthwhile | Unsure | 0 Participants |
| A = Virtual Reality Paradigm A | Was the Study Worthwhile | No | 0 Participants |
| A = Virtual Reality Paradigm A | Was the Study Worthwhile | Yes | 6 Participants |
| B = Virtual Reality Paradigm B | Was the Study Worthwhile | Unsure | 0 Participants |
| B = Virtual Reality Paradigm B | Was the Study Worthwhile | No | 0 Participants |
| B = Virtual Reality Paradigm B | Was the Study Worthwhile | Yes | 6 Participants |
| C = Non-Virtual Reality Paradigm A | Was the Study Worthwhile | No | 1 Participants |
| C = Non-Virtual Reality Paradigm A | Was the Study Worthwhile | Yes | 5 Participants |
| C = Non-Virtual Reality Paradigm A | Was the Study Worthwhile | Unsure | 0 Participants |
| D = Non-Virtual Reality Paradigm B | Was the Study Worthwhile | No | 0 Participants |
| D = Non-Virtual Reality Paradigm B | Was the Study Worthwhile | Unsure | 1 Participants |
| D = Non-Virtual Reality Paradigm B | Was the Study Worthwhile | Yes | 5 Participants |