Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
25 participants
INTERVENTIONAL
2019-09-23
2020-02-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Virtual Reality Headset with curated content
clinicians will wear VR immersive headset for up to 15 minutes during their break
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Reality Headset with curated content
clinicians will wear VR immersive headset for up to 15 minutes during their break
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* will have at least 5 shifts over the study period in the GW Hospital
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
George Washington University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neal Sikka
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neal K Sikka, MD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GW Hospital
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
051818
Identifier Type: -
Identifier Source: org_study_id