Burnout, ProfessionalNCT04132141
VR Breaks on Shift-worker Alertness
A study testing Virtual Reality Headset with curated content in people with Burnout, Professional, run by George Washington University at 1 site in United States.
Trial summary
Physician wellness is a hot topic today. Fatigue and alertness are common challenges faced during long work hours. Virtual reality is an immersive technology which has been demonstrated to distract people from pain, stress, and anxiety. Guided relaxation and meditation can impact alertness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Virtual Reality Headset with curated content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GW residents, physicians, medical students, and nurses between the ages of 18-65.
- will have at least 5 shifts over the study period in the GW Hospital
Who cannot join
- Unable to consent to study due to cognitive difficulty
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
- Sensitivity to flashing light or motion
- Pregnancy, or a medical condition where the participant is prone to frequent nausea or dizziness
- Recent stroke
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)
Trial locations and contacts
1 site in 1 country.
United States1 site
GW Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Effect of Immersive Virtual Reality Breaks on Shift-worker Alertness
Physician wellness is a hot topic today. Fatigue and alertness are common challenges faced during long work hours. Virtual reality is an immersive technology which has been demonstrated to distract people from pain, stress, and anxiety. Guided relaxation and meditation can impact alertness. There is no literature reporting the impact immersive technologies like VR sessions could have on alertness, a critical area of concern in health care today which impacts physician wellness, quality of care, and duty hours.
The investigator's long-term goal is to develop solutions that can be used across industries to improve human alertness. To solve this problem, the investigators propose to test the feasibility of using an immersive virtual reality experience as a scheduled break and measure the interventions effect on post-break alertness, stress, and anxiety. Previous work at our Institution has demonstrated that VR experiences can reduce pain, stress and anxiety in patients presenting to the emergency department.
Read the detailed description
Physician wellness is a hot topic today. Fatigue and alertness are common challenges faced during long work hours. Virtual reality is an immersive technology which has been demonstrated to distract people from pain, stress, and anxiety. Guided relaxation and meditation can impact alertness. There is no literature reporting the impact immersive technologies like VR sessions could have on alertness, a critical area of concern in health care today which impacts physician wellness, quality of care, and duty hours.
The investigator's long-term goal is to develop solutions that can be used across industries to improve human alertness. To solve this problem, the investigator proposes to test the feasibility of using an immersive virtual reality experience as a scheduled break and measure the interventions effect on post-break alertness, stress, and anxiety. Previous work at our Institution has demonstrated that VR experiences can reduce pain, stress and anxiety in patients presenting to the emergency department.
Hypothesis: Short immersive VR breaks are expected to increase alertness and reduce stress and anxiety in residents, physicians, and medical students working on shifts as compared to unstructured breaks.
Aim 1 will establish a biometric footprint of activities relating to the shift of a resident, physician, medical student, or nurse. Understanding how biometric parameters change when performing different activities will establish a baseline for comparing the effect of immersive VR breaks.
Aim 2 will seek to tag the activities a resident, physician, medical student, or nurse is performing during the shift to add context to the biometric data
Aim 3 will be to evaluate metrics for alertness, stress and anxiety of a resident, physician, medical student, or nurse during their shift and specifically determine how they change with immersive VR intervention
The proposed study will establish a new model for managing physician alertness, stress and anxiety and provide insights into viable and effective interventions to improve these parameters for other occupations. The expected improvement in alertness and reduction in stress and anxiety could be highly impactful in creating a safer workplace. These methods will also help derive biometric maps of physician activities that could be used for a variety of physician wellness interventions. The impact of this study could be wide reaching in occupational health.
- Conditions
- Burnout, Professional
- Being tested
- Virtual Reality Headset with curated content
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset with curated contentOther
clinicians will wear VR immersive headset for up to 15 minutes during their break
| Study group | Role | What they receive |
|---|---|---|
| VR intervention | Other | each subject will be own control. subjects breaks will be randomly assigned to VR or WT until they complete 3 for each type or a total of 6 Receives: Other: Virtual Reality Headset with curated content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psycho-motor Vigilance Testing (PVT)
response time measure of alertness using PVT software
Measured: PVT will be collected in each study shift and compared at the end of the study period about 4 months
Secondary outcomes (3)
Alertness
Self Reported level of alertness using 10 point Likert scale
Measured: Alertness will be collected in each study shift and compared at the end of the study period about 4 months
Stress
Self Reported level of stress using 10 point Likert scale
Measured: Stress will be collected in each study shift and compared at the end of the study period about 4 months
Anxiety
Self Reported level of anxiety using 10 point Likert scale
Measured: Anxiety will be collected in each study shift and compared at the end of the study period about 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start23 Sep 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each recruited subject completes 6 shifts with observation. Half the shifts have normal or wild type breaks, the other half are virtual reality breaks. The order is random.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Sikka, George Washington University
- Investigators
- Neal K Sikka, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132141
- Sponsor's protocol ID
- 051818
- Status last verified
- Nov 2021
- First submitted
- 15 Oct 2019
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith-Coggins R, Howard SK, Mac DT, Wang C, Kwan S, Rosekind MR, Sowb Y, Balise R, Levis J, Gaba DM. Improving alertness and performance in emergency department physicians and nurses: the use of planned naps. Ann Emerg Med. 2006 Nov;48(5):596-604, 604.e1-3. doi: 10.1016/j.annemergmed.2006.02.005. Epub 2006 May 2.
PubMed 17052562Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.
PubMed 19300585Dascal J, Reid M, IsHak WW, Spiegel B, Recacho J, Rosen B, Danovitch I. Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. Innov Clin Neurosci. 2017 Feb 1;14(1-2):14-21. eCollection 2017 Jan-Feb.
PubMed 28386517Han T, Nag A, Simorangkir RBVB, Afsarimanesh N, Liu H, Mukhopadhyay SC, Xu Y, Zhadobov M, Sauleau R. Multifunctional Flexible Sensor Based on Laser-Induced Graphene. Sensors (Basel). 2019 Aug 9;19(16):3477. doi: 10.3390/s19163477.
PubMed 31395810Langelotz C, Scharfenberg M, Haase O, Schwenk W. Stress and heart rate variability in surgeons during a 24-hour shift. Arch Surg. 2008 Aug;143(8):751-5. doi: 10.1001/archsurg.143.8.751.
PubMed 18711034
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality Breaks on Shift-worker Alertness
- ClinicalTrials.gov ID
- NCT04132141
- Acronym / sponsor ID
- 051818
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 25 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physician wellness is a hot topic today. Fatigue and alertness are common challenges faced during long work hours. Virtual reality is an immersive technology which has been demonstrated to distract people from pain, stress, and anxiety. Guided relaxation and meditation can impact alertness. There is no literature reporting the impact immersive technologies like VR sessions could have on alertness, a critical area of concern in health care today which impacts physician wellness, quality of care, and duty hours.
The investigator's long-term goal is to develop solutions that can be used across industries to improve human alertness. To solve this problem, the investigators propose to test the feasibility of using an immersive virtual reality experience as a scheduled break and measure the interventions effect on post-break alertness, stress, and anxiety. Previous work at our Institution has demonstrated that VR experiences can reduce pain, stress and anxiety in patients presenting to the emergency department.
Detailed description
Physician wellness is a hot topic today. Fatigue and alertness are common challenges faced during long work hours. Virtual reality is an immersive technology which has been demonstrated to distract people from pain, stress, and anxiety. Guided relaxation and meditation can impact alertness. There is no literature reporting the impact immersive technologies like VR sessions could have on alertness, a critical area of concern in health care today which impacts physician wellness, quality of care, and duty hours.
The investigator's long-term goal is to develop solutions that can be used across industries to improve human alertness. To solve this problem, the investigator proposes to test the feasibility of using an immersive virtual reality experience as a scheduled break and measure the interventions effect on post-break alertness, stress, and anxiety. Previous work at our Institution has demonstrated that VR experiences can reduce pain, stress and anxiety in patients presenting to the emergency department.
Hypothesis: Short immersive VR breaks are expected to increase alertness and reduce stress and anxiety in residents, physicians, and medical students working on shifts as compared to unstructured breaks.
Aim 1 will establish a biometric footprint of activities relating to the shift of a resident, physician, medical student, or nurse. Understanding how biometric parameters change when performing different activities will establish a baseline for comparing the effect of immersive VR breaks.
Aim 2 will seek to tag the activities a resident, physician, medical student, or nurse is performing during the shift to add context to the biometric data
Aim 3 will be to evaluate metrics for alertness, stress and anxiety of a resident, physician, medical student, or nurse during their shift and specifically determine how they change with immersive VR intervention
The proposed study will establish a new model for managing physician alertness, stress and anxiety and provide insights into viable and effective interventions to improve these parameters for other occupations. The expected improvement in alertness and reduction in stress and anxiety could be highly impactful in creating a safer workplace. These methods will also help derive biometric maps of physician activities that could be used for a variety of physician wellness interventions. The impact of this study could be wide reaching in occupational health.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each recruited subject completes 6 shifts with observation. Half the shifts have normal or wild type breaks, the other half are virtual reality breaks. The order is random.
| Arm | Type | Receives |
|---|---|---|
| VR intervention | Other | Other: Virtual Reality Headset with curated contenteach subject will be own control. subjects breaks will be randomly assigned to VR or WT until they complete 3 for each type or a total of 6 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GW residents, physicians, medical students, and nurses between the ages of 18-65.
- will have at least 5 shifts over the study period in the GW Hospital
Key exclusion criteria (6 listed)
- Unable to consent to study due to cognitive difficulty
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
- Sensitivity to flashing light or motion
- Pregnancy, or a medical condition where the participant is prone to frequent nausea or dizziness
- Recent stroke
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 |
|---|---|---|
| Virtual Reality Headset with curated contentclinicians will wear VR immersive headset for up to 15 minutes during their break | Other | VR intervention |
Primary outcome
Psycho-motor Vigilance Testing (PVT)
Time frame: PVT will be collected in each study shift and compared at the end of the study period about 4 months
response time measure of alertness using PVT software
3 secondary outcomes
Alertness
Time frame: Alertness will be collected in each study shift and compared at the end of the study period about 4 months
Stress
Time frame: Stress will be collected in each study shift and compared at the end of the study period about 4 months
Anxiety
Time frame: Anxiety will be collected in each study shift and compared at the end of the study period about 4 months
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 17052562Smith-Coggins R, Howard SK, Mac DT, Wang C, Kwan S, Rosekind MR, Sowb Y, Balise R, Levis J, Gaba DM. Improving alertness and performance in emergency department physicians and nurses: the use of planned naps. Ann Emerg Med. 2006 Nov;48(5):596-604, 604.e1-3. doi: 10.1016/j.annemergmed.2006.02.005. Epub 2006 May 2.
- Background: PubMed 19300585Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.
- Background: PubMed 28386517Dascal J, Reid M, IsHak WW, Spiegel B, Recacho J, Rosen B, Danovitch I. Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. Innov Clin Neurosci. 2017 Feb 1;14(1-2):14-21. eCollection 2017 Jan-Feb.
- Background: PubMed 31395810Han T, Nag A, Simorangkir RBVB, Afsarimanesh N, Liu H, Mukhopadhyay SC, Xu Y, Zhadobov M, Sauleau R. Multifunctional Flexible Sensor Based on Laser-Induced Graphene. Sensors (Basel). 2019 Aug 9;19(16):3477. doi: 10.3390/s19163477.
- Background: PubMed 18711034Langelotz C, Scharfenberg M, Haase O, Schwenk W. Stress and heart rate variability in surgeons during a 24-hour shift. Arch Surg. 2008 Aug;143(8):751-5. doi: 10.1001/archsurg.143.8.751.
- 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.
Neal K Sikka, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset with curated content in people with Burnout, Professional, run by George Washington University 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 2 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: stopped early, as of the sponsor's last update on 14 Dec 2021. 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. 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?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Psycho-motor Vigilance Testing (PVT) (time frame: PVT will be collected in each study shift and compared at the end of the study period about 4 months). 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 NCT04132141, which also lists 5 linked publications.
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 14 Dec 2021.