NCT04132141

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
Last Updated

December 14, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 15, 2019

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Alertness

    Alertness will be collected in each study shift and compared at the end of the study period about 4 months

  • Stress

    Stress will be collected in each study shift and compared at the end of the study period about 4 months

  • Anxiety

    Anxiety will be collected in each study shift and compared at the end of the study period about 4 months

Study Arms (1)

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

Other: Virtual Reality Headset with curated content

Interventions

clinicians will wear VR immersive headset for up to 15 minutes during their break

VR intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GW Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (5)

  • 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.

    PMID: 17052562BACKGROUND
  • Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.

    PMID: 19300585BACKGROUND
  • 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.

    PMID: 28386517BACKGROUND
  • 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.

    PMID: 31395810BACKGROUND
  • 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.

    PMID: 18711034BACKGROUND

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Neal K Sikka, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
all data is collected by the Research assistant and de-identified. The investigator will not know which data belongs to which participant
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 18, 2019

Study Start

September 23, 2019

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

December 14, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations