Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial
Phase: NA
Conditions: Anxiety, Burn Out
Sponsor: Mayo Clinic

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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Acceptability of Virtual Reality Experience by 
Health Care Providers for 
Improving Focus and Reducing 
Anxiety:  A Pilot Trial. 
 
 
 
 
NCT04622527 
 
 
 
 
10/23/2020

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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Aims, purpose, or objectives: 
We propose to conduct a pilot study on the safety and impact of two nature-based virtual reality (VR) interventions 
on levels of anxiety and inattention. 
 
Paradigms like this have been used previously to study the impact of VR on anxiety1,2 but this specific intervention 
has not. Thus, it is reasonable to assume that it is feasible, but unique to the study of workplace anxiety and 
inattention, and in its design too.   
 
The proposed investigation will apply two novel paradigms using proprietary VR (R-VR) 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.  Results from this pilot study will be used to 
decide if a larger efficacy study with longer duration of daily VR experience will be developed. 
  
The primary aims: 
1) Evaluate the safety and acceptability of the R-VR 
 
2) Evaluate the adherence to the R-VR 
 
3) Evaluate the impact of using R-VR on anxiety and inattention levels 
 
4) Compare the impact of two R-VR paradigms on anxiety and to correlate this impact with baseline self-
efficacy 
 
The major constructs that will be examined in this proposal are (1) Safety; (2) Anxiety; (3) Inattention; (4) Self-
Efficacy.  It is expected that this exploratory work will lay the foundation for future studies on anxiety and 
inattention interventions at work.   
 
Background:   
 
Is anxiety in the workplace relevant? According to large population-based surveys, up to 33.7 percent of the 
population is affected by an anxiety disorder during their lifetime3. In the workplace, millennials and people who 
fall into the “Gen Z” category are especially vulnerable4, and 54 percent of workers under 23 said they felt anxious 
or nervous due to stress in the preceding month5.  
 
While some anxiety may improve job performance6 by motivating people, many studies now document the 
detrimental impact of anxiety on job performance. Impostor syndrome7, burnout8, and decreased satisfaction with 
work9 are just some of the negative impacts of anxiety. Also, much research also demonstrates that the greater the 
anxiety, the lower degree of hope and sense of possibility10,11, with a subsequent sense of demoralization. In fact, 
anxious CEOs may be risk-averse verging on paranoid12.  
 
Furthermore, anxiety disorders are also very costly. The total costs of anxiety disorders were approximately $40 
Billion in the US in the 1990s13 and € 74.4 billion for 30 European EU countries in 201014. The current costs are 
likely to be much higher.  
 
Do we really need an intervention for anxiety at work? Although there are many conventional treatments for 
anxiety disorders, 40 percent of people who are treated relapse or are refractory15. Also, the percentage of people 

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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with anxiety disorders who seek help is lower than 50 percent. Having an ancillary and readily available 
intervention for state anxiety in the workplace is likely to be helpful. 
 
Why will we not focus on diagnoses per se? The category of “anxiety disorders” has raised much controversy 
recently, and there is a trend to examine traits in research that correlate with biology rather than consider 
diagnostic categories16.  This is a feasibility study in a general population not focused on anxiety disorders but 
focused on the acceptability of such an intervention. 
 
Why will we use nature-based interventions? 
Studies indicate that forest walks are especially helpful in improving anxiety17-19. Even short-term exposures to 
nature decrease anxiety and improve happiness and wellbeing20-24. 
 
In a recent systematic review25, many studies indicate that VR was an effective form of therapy for mental 
disorders compared to “treatment as usual”. In addition, there are an increasing number of studies that have 
demonstrated that VR may be helpful for anxiety26,27. Specifically, it has been shown to be useful where worry is 
excessive28, for social anxiety, post-traumatic stress disorder, and panic attacks26. 
 
For these reasons, combining nature-based interventions with VR is a potentially feasible approach to decrease 
anxiety in the workplace. 
 
While the exact mechanism is unknown, some preliminary data indicates that this might occur by shifting 
proportional power from higher Beta frequencies into lower Beta frequencies, and significantly reduced broadband 
Beta activity in the anterior cingulate cortex2. And even after one session of VR, there is decreased activity in the 
dorsolateral prefrontal cortex and medial prefrontal cortex that increases over subsequent sessions29. 
 
Study Design and Methods 
 
Design: This is a single blinded randomized cross-over study.  The participants will be randomly assigned the 
order of the paradigms viewed in the R-VR or as videos on the computer.  The randomization will be through 
REDCap, as programmed by the study statisticians.  The R-VR with the pre-programmed paradigms and 
corresponding non-VR videos will be labelled A through D.    The coordinators will be informed via REDCap 
about which the experience to provide the participants for each of the study visits: A-D for Visits 1-4.   
 
Data Collection 
 
• Participants will complete study surveys/questionnaires through REDCap.  The coordinator will provide the 
iPad digital or paper copy version of the survey/questionnaire to the participant for the in-person visits and 
by email link or phone interview for the remote visits.   
 
• Survey data collection in this study will utilize REDCap30.  The only anticipated paper source documents 
will be if participant chooses to complete surveys via paper copy or phone collection, which will then have 
select variables entered directly into the REDCap data entry system.  All other data collection will be 
entered directly into this password protected system.   
 
 
 

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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Visit Flow and Timeline 
 
 
Day 0 
Day 1 
Day 4 
Day 7 
Day 10 
Visit Number 
V02 
V1a2 
 
V1b 
V2a 
 
V2b 
V3a 
 
V3b 
V4a 
 
V4b 
 
 
+ 0 day to +7 
days from 
Consent 
VR/Video  
Immediately 
following 
VR/Video 
Prior to 
VR/Video  
VR/Video 
Immediately 
following 
VR/Video 
Prior to 
VR/Video 
VR/Video  
Immediately 
following 
VR/Video 
Prior to 
VR/Video  
VR/Video 
Immediately 
following 
VR/Video 
Informed Consent 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics Form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History  
X 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Events 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Concomitant Medications 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
R-VR Intervention 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Brief Resilience  
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Evaluate Response to the VR 
experience (HUMAN) 
 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
Emotional distress 
 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
Cognitive Function 
 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
Self-efficacy  
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Anxiety 
 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
Satisfaction Survey  
 
 
 
 
 
 
 
 
 
 
 
 
X 
1Consent can be completed digitally in person or through remote consenting 
2Visit 0 and Visit 1 can occur on same day or on separate occasions at the participant’s convenience. 
 
Assessments  
 
Study Entry Screen/Safety: 
• Demographics Form:  This form will collect demographics (age, sex, education, marital status, job title), 
and other lifestyle history of the research participant.  
• Medical History Form: This form will collect history of comorbid conditions such as head injury, seizures, 
major mental illness or anything that could interfere with the VR experience (e.g. eye sight).  This 
information will be collected via self-report and health record abstraction. 
• Adverse Events:  Pre-post measures will be obtained for dizziness; stomach awareness; headaches; 
eyestrain and lightheadedness; nausea; seizures in individuals with photosensitivity; disorientation; 
temporary (short term) loss of spatial awareness. 
• Concomitant Medications:  Current medications (name, dosing, and indications) will be collected at every 
patient encounter. 
 
Outcomes:  
• Anxiety:  State-Trait Anxiety Inventory (STAI-Y1)31-35 This 20 item self-report measure indicates the 
intensity of feelings of anxiety; it distinguishes between state anxiety (a temporary condition experienced in 
specific situations) and trait anxiety (a general tendency to perceive situations as threatening). This uses a 4 
point visual analog scale and the participant indicates how they feel in the moment (1=not at all to 4=very 
much so). 
• Brief Resilience Scale (6 item)36: This brief 6 item survey is a validated way to assess resilience (ability to 
bounce back or recover from stress).  It uses a 5 point visual analog scale to measure ability to bounce back 
where 1 is ‘strongly disagree’ and 5 is ‘strongly agree’ with a resilience focused statement. 

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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• Human (7 items): This form has been developed by the Reulay sponsor and is used by the sponsor to 
individualize the Virtual Reality Experience to each person depending on the issues the person needs 
addressed.  It provides 7 options and the participant will indicate the level of which each item is a current 
issue from 1= not at all to 5=a great deal.  For this study, we will administer this questionnaire and evaluate 
the participant response to the two VR experiences based on how they responded to this survey. 
• Emotional Distress: Adapted from the Emotional Distress-short form 7a (7 items)37.  The PROMIS Anxiety 
item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal 
(tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). 
Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Only 
one behavioral avoidance item is included in the adult item bank; therefore, behavioral fear avoidance is 
not fully evaluated. The anxiety measures are universal rather than disease-specific. The original adult short 
form (7a), which is being used in this study was constructed by the domain team with a focus on 
representing the range of the trait and also representing the content of the item bank. Domain experts 
reviewed short forms to give input on the relevance of each item. Psychometric properties and clinical input 
were both used and likely varied in importance across domains. Each item on the measure is rated on a 5-
point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 
with higher scores indicating greater severity of anxiety. The original form instructed participants to think 
about the past seven days, but for purposes of this study, we will reword the question to focus on the 
current time (‘now’). Therefore due to the change in directions of the reference point, our version of this 
measure is unvalidated and cannot be compared to the general population.   
• Cognitive Function short form 6a (6 items)37 : The PROMIS Cognitive Function and Cognitive Function 
Abilities Subset item banks assess patient-perceived cognitive deficits. Facets include mental acuity, 
concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive 
functions. The extent to which cognitive impairments interfere with daily functioning, whether other people 
observe cognitive impairments, and the impact of cognitive dysfunction on quality of life are also assessed. 
• Self-efficacy (Short Form 4a – 4 items)37:  This PROMIS Self-efficacy Scale defines self-efficacy as 
confidence in one’s ability to successfully perform specific tasks or behaviors. It assesses confidence in 
one’s ability to successfully perform specific tasks or behaviors related to one's health in a variety of 
situations. Each item on the measure is rated on a 5-point scale (1=I am not at all confident; 2=I am a little 
confident; 3=I am somewhat confident; 4=I am quite confident; 5=I am very confident) 
• Satisfaction with the program:  This questionnaire is adapted from Was it Worth it Questionnaire (WIWI)38 
and the Reulay Qualitative Survey (RQS) to  measure study and RV satisfaction.  It will be administered to 
the participants prior to discharge after completing the intervention at the end of the study, probing their 
satisfaction with the research study. These data could be used to assess the feasibility of the intervention by 
asking the patient if the entire research experience was worth it for them. 
 
Acceptability and Adherence to Intervention: 
• Acceptability will be measured through the patient satisfaction survey at the end of the study. 
• Adherence to the R-VR will be assessed by collecting attendance for study visits 1-4. 
 
 
Resources 
REDCap will be utilized for data collection using created online forms. Clinician investigators will provide 
medical oversight. Tools needed for this intervention include one R-VR for each paradigm for a total of 2 R-VRs 
and a computer for the non VR experiences. 
 

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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Study Design 
We will use standardized procedures to ensure uniform instructions and support for all participants for the 
recruitment, screening, and study entry.   
 
Recruitment 
Participants will be recruited from Mayo Clinic healthcare professionals.  We propose to recruit, consent and 
screen a convenient sample of 36 participants through IRB approved contact materials in order to enroll 24 to 
study. All participants who respond to the recruitment message will be pre-screened for inclusion and exclusion 
criteria via a telephone pre-screen.  Those who meet criteria will be invited to a consent visit followed by a study 
screening visit.  After consent and screening has taken place, participants who meet all study entry criteria will be 
invited to participate in the study.  
 
Consent and Screen 
Study coordinator will discuss possible participation with the potential participant who has expressed an interest in 
the study.  The study coordinator will begin by introducing the study details, and after determining that the 
participant has continued interest in study participation, will move on to the study consent.  If the participant 
chooses to consent, the study coordinator will screen the participant for study entry inclusion/exclusion criteria.  If 
study entry criteria are met, the participant will begin their study participation. They will be asked to complete the 
study surveys/questionnaires, and after this is completed the participant will be instructed on the R-VR device and 
the video viewing experiences. 
Video Experience Procedure 
Participants will be scheduled for a 30-min office visit. After a verbal description of the study process and 
completion of IRB consent form, participants will complete the demographic and other baseline questionnaires.  
The coordinator will instruct the participant on certain procedures dependent on the study participant’s 
randomization and visit:  
R-VR Experience: Study participant will be asked to complete a set of questionnaires, following completion they 
will be seated in a swivel chair in the center of the research room, given basic instruction on the VR headgear 
[Oculus Quest], and then offered the opportunity to experience the intervention event.  The approximately 10 
minute VR event involves one of two scenes (randomly selected by REDCap):  Scene 1 is designed for relaxation 
in nature with natural scenery such as trees, streams and deer, or Scene 2 designed to help the participant focus 
with natural scenery such as glowing embers and fireflies. After a VR experience, the headgear will be removed 
and the participants will be asked to complete a second round of questionnaires. 
Computer Video Experience:  Study participant will be asked to complete a set of questionnaires, following by 
being seated at a computer and asked to watch a video with one of two scenes: (Scene 1) natural scenery such as 
trees, streams and deer; (Scene 2) natural scenery such as glowing embers and fireflies.  After this viewing they 
will be asked to complete a set of surveys. 
All will be remunerated up to $40 at the end of their study participation.  This amount will be prorated based on the 
number of visits completed 
This process will provide a within-participant control, allowing us to investigate whether the VR experience is safe 
and results in significantly more change than the Video experience.  
 
Participant Information 

Virtual Reality Pilot 
PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
Page 8 of 10 
 
 
Target accrual: 24 to be randomized (36 to be consented and screened). 
 
Participant population:  24 adults 
 
Inclusion Criteria:  
1. 18 years of age or older at the time of consent 
2. Healthcare Professional at Mayo Clinic 
3. Not pregnant by participant self-report at time of consent 
4. Have the ability to provide informed consent 
5. Have no contraindicated comorbid health conditions as determined by the clinical investigators 
 
Exclusion Criteria:   
1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis 
2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality 
of life  
3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which impacts 
the patients’ QOL, stress or anxiety 
4. Currently has photosensitivity 
5. Cannot tolerate virtual reality experiences 
6. An unstable medical or mental health condition as determined by the physician investigator (e.g. pre-
existing eye strain, seizures, dizziness, nausea) 
 
Data Analysis 
 
Power Statement:  The sample size for this pilot investigation (N=24) was established after considering both the 
statistical implications and the amount of project effort and resources required to recruit and study this unique 
participant population. 
Data Analysis Plan: Data related to participant recruitment will be summarized, including the frequency of calls 
and the reasons for failing screening criteria.  In all cases, data will be summarized using mean ± SD for 
continuous variables and frequency percentages for nominal variables. Details will be documented and 
summarized for any participants who experience adverse events or are unable to complete the 10-minute VR 
experience for any reason. The percentage of participants who undergo the initial VR experience (V2) but 
discontinue study participation without returning for the 2nd VR experience (V3) will be summarized and 
compared between scenes using Fisher’s exact test. Anxiety, stress, cognition will be assessed immediately 
before/after and 24 hours following each VR experience.  Within and between group comparisons will be 
performed using appropriate repeated measures analyses (e.g. paired t-test, repeated measures ANOVA) taking 
into account the two group repeated measures cross-over study design. In all cases, findings will be summarized 
using point estimates and corresponding 95% confidence intervals.  
 
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PI: IT Croghan, PhD 
Mayo Clinic – NCT04622527 
 
 
 
 
 
 
 
 
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