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VR Breaks on Shift-worker Alertness

Primary Purpose

Burnout, Professional

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Headset with curated content
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Burnout, Professional

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • GW Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

VR intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Psycho-motor Vigilance Testing (PVT)
response time measure of alertness using PVT software

Secondary Outcome Measures

Alertness
Self Reported level of alertness using 10 point Likert scale
Stress
Self Reported level of stress using 10 point Likert scale
Anxiety
Self Reported level of anxiety using 10 point Likert scale

Full Information

First Posted
October 15, 2019
Last Updated
November 30, 2021
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT04132141
Brief Title
VR Breaks on Shift-worker Alertness
Official Title
Effect of Immersive Virtual Reality Breaks on Shift-worker Alertness
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
all data is collected by the Research assistant and de-identified. The investigator will not know which data belongs to which participant
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR intervention
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Virtual Reality Headset with curated content
Intervention Description
clinicians will wear VR immersive headset for up to 15 minutes during their break
Primary Outcome Measure Information:
Title
Psycho-motor Vigilance Testing (PVT)
Description
response time measure of alertness using PVT software
Time Frame
PVT will be collected in each study shift and compared at the end of the study period about 4 months
Secondary Outcome Measure Information:
Title
Alertness
Description
Self Reported level of alertness using 10 point Likert scale
Time Frame
Alertness will be collected in each study shift and compared at the end of the study period about 4 months
Title
Stress
Description
Self Reported level of stress using 10 point Likert scale
Time Frame
Stress will be collected in each study shift and compared at the end of the study period about 4 months
Title
Anxiety
Description
Self Reported level of anxiety using 10 point Likert scale
Time Frame
Anxiety will be collected in each study shift and compared at the end of the study period about 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal K Sikka, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GW Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17052562
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. doi: 10.1016/j.annemergmed.2006.02.005. Epub 2006 May 2.
Results Reference
background
PubMed Identifier
19300585
Citation
Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.
Results Reference
background
PubMed Identifier
28386517
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.
Results Reference
background
PubMed Identifier
31395810
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):3477. doi: 10.3390/s19163477.
Results Reference
background
PubMed Identifier
18711034
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.
Results Reference
background

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VR Breaks on Shift-worker Alertness

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