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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04132141
Other study ID # 051818
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 23, 2019
Est. completion date February 27, 2020

Study information

Verified date November 2021
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date February 27, 2020
Est. primary completion date February 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Reality Headset with curated content
clinicians will wear VR immersive headset for up to 15 minutes during their break

Locations

Country Name City State
United States GW Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67. — View Citation

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. Review. — View Citation

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). pii: E3477. doi: 10.3390/s19163477. — View Citation

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. — View Citation

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. Epub 2006 May 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psycho-motor Vigilance Testing (PVT) 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 Alertness 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
Secondary Stress 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
Secondary Anxiety 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
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