AnxietyNCT04622527
A Study to Assess Virtual Reality by Healthcare Providers: A Pilot Study
A study testing Random assigned paradigm viewing order in people with Anxiety and Burn Out, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Random assigned paradigm viewing order
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial
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.
Read the 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.
- Being tested
- Random assigned paradigm viewing order
- Keywords
- anxiety, burnout
- Medical subject headings
- Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random assigned paradigm viewing orderOther
Participants experience the paradigm in a random order
| Study group | Role | What they receive |
|---|---|---|
| A = Virtual Reality paradigm A | Active comparator | Begin with Paradigm A virtual reality headgear Receives: Other: Random assigned paradigm viewing order |
| B = Virtual Reality paradigm B | Active comparator | Begin with Paradigm B virtual reality headgear Receives: Other: Random assigned paradigm viewing order |
| C = Non-Virtual Reality paradigm A | Sham comparator | Begin with Paradigm A without virtual reality headgear Receives: Other: Random assigned paradigm viewing order |
| D = Non-Virtual Reality paradigm B | Sham comparator | Begin with Paradigm B without virtual reality headgear Receives: Other: Random assigned paradigm viewing order |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
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?".
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Relay Therapeutics, Inc.
- Responsible party
- Principal investigator, Ivana T Croghan, PhD, Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Principal investigator, Mayo ClinicBrent Bauer, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622527
- Sponsor's protocol ID
- 20-009579
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2020
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35352605
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Virtual Reality Experience by Health Care Providers for Improving Focus and Reducing Anxiety: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04622527
- Acronym / sponsor ID
- 20-009579
- Keywords
- anxiety, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Relay Therapeutics, Inc.
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| A = Virtual Reality paradigm A | Active comparator | Other: Random assigned paradigm viewing orderBegin with Paradigm A virtual reality headgear |
| B = Virtual Reality paradigm B | Active comparator | Other: Random assigned paradigm viewing orderBegin with Paradigm B virtual reality headgear |
| C = Non-Virtual Reality paradigm A | Sham comparator | Other: Random assigned paradigm viewing orderBegin with Paradigm A without virtual reality headgear |
| D = Non-Virtual Reality paradigm B | Sham comparator | Other: Random assigned paradigm viewing orderBegin with Paradigm B without virtual reality headgear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Random assigned paradigm viewing orderParticipants experience the paradigm in a random order | Other | A = Virtual Reality paradigm A, B = Virtual Reality paradigm B, C = Non-Virtual Reality paradigm A, D = Non-Virtual Reality paradigm B |
Primary outcome
State-Trait Anxiety Inventory (STAI Y1)
Time frame: 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.
1 secondary outcome
Was the Study Worthwhile
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35352605Croghan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana T Croghan, PhD principal investigator
Mayo Clinic
Brent Bauer, MD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Random assigned paradigm viewing order in people with Anxiety and Burn Out, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI Y1) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04622527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.