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Digital Interventions for Detection and Reduction of Moral Distress (VR)

Primary Purpose

Moral Injury, Distress, Emotional

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational moral injury video
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Moral Injury focused on measuring Depression, Anxiety, Stress, Moral Injury, Moral Distress, Loneliness

Eligibility Criteria

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

Inclusion Criteria:

  • Staff or healthcare providers working at Unity Health Toronto
  • 18 years of age or older
  • Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)

Exclusion Criterion:

- Non-Unity Health Toronto staff

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

VR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress

Outcomes

Primary Outcome Measures

Feasibility evaluation of the virtual reality environment
The primary outcome measure will be a comparison of MIOS (Moral Injury Outcome Scale) and PSS (Perceived Stress Scale) scores before and after watching an educational video on moral injury; feasibility of this platform will be assessed based on a feasibility questionnaire and changes in score.

Secondary Outcome Measures

Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.
Feasibility of the mobile platform will be measured based on dropout rate

Full Information

First Posted
July 28, 2021
Last Updated
October 5, 2021
Sponsor
Unity Health Toronto
Collaborators
Toronto Metropolitan University, University of Toronto, University of Ontario Institute of Technology, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05001542
Brief Title
Digital Interventions for Detection and Reduction of Moral Distress
Acronym
VR
Official Title
Could Digital Interventions Help Understand And "Flatten The Curve" Of Distress Due To Moral Injury Among Health Care Workers During The COVID Pandemic?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Toronto Metropolitan University, University of Toronto, University of Ontario Institute of Technology, McMaster 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
Stress, anxiety, distress and depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. This study will evaluate a novel virtual reality platform to gather the "distress experience" of frontline healthcare workers at Unity Health Toronto in real time during the ongoing COVID pandemic by developing and showing feasibility of digital technology (Virtual Reality (VR) and mobile app) as a digital platform to understand the causes and ultimately reduce the moral distress of healthcare providers during the COVID-19 pandemic. The project will develop innovations which can be used for future pandemics and other contexts prone to producing moral distress and injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moral Injury, Distress, Emotional
Keywords
Depression, Anxiety, Stress, Moral Injury, Moral Distress, Loneliness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Users will go through a VR experiment before and after a brief interventional informative video describing moral distress. The VR experiment is a simulation that will lead the participant through a stressful experience about moral distress during the COVID-19 pandemic. Before, during, and after the experiment, active and physiological data will be collected from the participant to monitor their level of acute distress and health, respectively. Following the experiment, active and passive data will be collected on each user through the investigators' mobile platform (DiiG) for longitudinal monitoring of moral distress and injury.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
VR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress
Intervention Type
Other
Intervention Name(s)
Educational moral injury video
Intervention Description
Educational video that addresses the identification of moral injury and distress in frontline healthcare workers during COVID-19; offers available interventions at the levels of individual, team and organization
Primary Outcome Measure Information:
Title
Feasibility evaluation of the virtual reality environment
Description
The primary outcome measure will be a comparison of MIOS (Moral Injury Outcome Scale) and PSS (Perceived Stress Scale) scores before and after watching an educational video on moral injury; feasibility of this platform will be assessed based on a feasibility questionnaire and changes in score.
Time Frame
60 minutes (during the intervention)
Secondary Outcome Measure Information:
Title
Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.
Description
Feasibility of the mobile platform will be measured based on dropout rate
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Staff or healthcare providers working at Unity Health Toronto 18 years of age or older Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher) Exclusion Criterion: - Non-Unity Health Toronto staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkat Bhat, MD MSc
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34871178
Citation
Nguyen B, Torres A, Sim W, Kenny D, Campbell DM, Beavers L, Lou W, Kapralos B, Peter E, Dubrowski A, Krishnan S, Bhat V. Digital Interventions to Reduce Distress Among Health Care Providers at the Frontline: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Feb 16;11(2):e32240. doi: 10.2196/32240.
Results Reference
derived

Learn more about this trial

Digital Interventions for Detection and Reduction of Moral Distress

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