- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132141
VR Breaks on Shift-worker Alertness
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- GW Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: VR intervention
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
|
clinicians will wear VR immersive headset for up to 15 minutes during their break
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
PVT will be collected in each study shift and compared at the end of the study period about 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alertness
Time Frame: Alertness will be collected in each study shift and compared at the end of the study period about 4 months
|
Self Reported level of alertness using 10 point Likert scale
|
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
|
Self Reported level of stress using 10 point Likert scale
|
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
|
Self Reported level of anxiety using 10 point Likert scale
|
Anxiety will be collected in each study shift and compared at the end of the study period about 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neal K Sikka, MD, George Washington University
Publications and helpful links
General Publications
- Dascal 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.
- 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.
- Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.
- Han 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.
- Langelotz 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 051818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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