Clinical trial NCT05923398: Digital Interventions to Understand and Mitigate Stress Response
Official title: Digital Interventions to Understand and Mitigate Stress Response: Process & Content Evaluation to Move From Feasibility (SRL-4) to Simulated Demonstration (SRL-6)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress, Emotional
Stress Response Among Nursing Professionals During the COVID-19
Stress Reaction; Acute
Keywords: Moral distress
Stress
Virtual Reality
Wearables
Web-based intervention
Nursing professionals
Nursing staff
Distress
COVID-19
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
name: University of Toronto
name: University of Ontario Institute of Technology
name: Boston University
name: University of Ottawa
name: Western University, Canada
name: Centre for Addiction and Mental Health
First posted: 2023-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Over approximately 3.5 months, each nursing professional will participate in the following:

A) Undergo a virtual reality scenario to understand and reduce stress and moral distress related to difficult decision-making in complex moral situations during the COVID-19 pandemic.

B) Use a web-based platform to measure stress, moral distress, and other mental health symptoms, as well as a commercial wearable device to collect physiological, sleep, and activity data to understand and examine the contribution of active and passive data to stress and moral distress.

During analysis, once all passive and active data is collected we will create a personal digital phenotype profile (pDPP) based on the physiological data collected during a morally challenging situation in a virtual environment as well as the wearable and web-based data to help understand stress and moral distress at the individual level.
Primary purpose: OTHER

Brief summary: Stress, anxiety, distress, and burnout are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. The understanding of factors underlying distress and resilience in complex workplace contexts is limited, and there are limited evidence-based interventions for stress and moral distress among frontline healthcare workers. The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality \[VR\], a web-based platform, and a wearable \[Oura Ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals.

Detailed description: The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality \[VR\], a web-based platform, and a wearable \[Oura Ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals. This study involves participation in an in-person VR setup and the use of an app and a wearable device over the duration of the study (14+ weeks). The immersive VR component of the study involves a virtual experience of navigating a challenging workplace scenario to understand stress response and provide an overview of interventions that can be used to reduce workplace stress. Upon completion of the in-person VR visit, participants will continue to use the app and the wearable for the study duration to understand stress responses in their actual workplaces. Participants will have real-time access to their essential data on wellness collected through the app and wearable (e.g., sleep, activity, physiological signals, anxiety symptoms). The Digital Intervention Suite (combined use of these three components: VR, app, and wearable) is essential for a thorough understanding of stress and moral distress. This is a de-identified study, and the team will only have access to de-identified data for analysis at the end of the study.

Eligibility criteria: Inclusion criteria:

1. Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
2. Ownership of a smartphone.

Exclusion criteria:

1. History of seizures (except febrile seizure).
2. Use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators).
3. A score of ≥ 15 on the Generalized Anxiety Disorder (GAD-7) scale
4. A score of ≥ 20 on the Patient Health Questionnaire (PHQ-9).

Primary outcomes:
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: Approximately 3.5 months
measure: Moral Injury Outcome Scale (MIOS-4; 4 item scale)
timeFrame: Approximately 3.5 months
Secondary outcomes:
measure: UCLA Loneliness Scale (3 item scale)
timeFrame: Approximately 3.5 months
measure: Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)
timeFrame: Approximately 3.5 months
measure: Generalized Anxiety Disorder Scale (GAD-2; 2 item scale)
timeFrame: Approximately 3.5 months
measure: Patient Health Questionnaire (PHQ-9; 9 item scale)
timeFrame: Approximately 3.5 months
measure: Patient Health Questionnaire (PHQ-2; 2 item scale)
timeFrame: Approximately 3.5 months
measure: Moral Injury Outcome Scale (MIOS-14; 22 item scale)
timeFrame: Approximately 3.5 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Venkat Bhat, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: