- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001542
Digital Interventions for Detection and Reduction of Moral Distress (VR)
October 5, 2021 updated by: Venkat.Bhat, Unity Health Toronto
Could Digital Interventions Help Understand And "Flatten The Curve" Of Distress Due To Moral Injury Among Health Care Workers During The COVID Pandemic?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm
VR simulation exercise with a digital follow-up component to help assess the physiological and psychological indicators of moral distress
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility evaluation of the virtual reality environment
Time Frame: 60 minutes (during the intervention)
|
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.
|
60 minutes (during the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility evaluation of a mobile platform to understand the continuum of stress and moral distress.
Time Frame: Up to 8 weeks
|
Feasibility of the mobile platform will be measured based on dropout rate
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Venkat Bhat, MD MSc, Unity Health Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
July 28, 2021
First Submitted That Met QC Criteria
August 5, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
October 7, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-066
- CPCA-0592 (Other Grant/Funding Number: DND Canada: IDEaS Competitive Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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