Digital Interventions to Understand and Mitigate Stress Response

NCT ID: NCT05923398

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-08

Brief Summary

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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

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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.

Conditions

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Distress, Emotional Stress Response Among Nursing Professionals During the COVID-19 Stress Reaction; Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Group

During the duration of the study, all participants will use the Digital Intervention Suite (a web-based component, a VR platform, and wearable device) to measure passive and active data, such as: psychological variables (e.g., moral distress, anxiety, and depression) and physiological variables (e.g., heart rate and sleep).

Group Type EXPERIMENTAL

Digital Intervention Group

Intervention Type BEHAVIORAL

Participants will use a Digital Intervention Suite composed of a virtual reality (VR) scenario, a web-based platform, and a wearable device to assess their stress response in near-real time and in a hypothetical stressful scenario.

During the VR scenario, physiological signals such as Galvanic Skin Response (GSR), Electrocardiogram (ECG), Respiratory Independence (RI), and Photoplethysmography will be measured. Additionally, an educational intervention video on how to deal with stress and distress will be shown to participants. We will then request participants to practice the skills taught during the intervention video in the VR scenario.

The wearable device (Oura Ring) will measure sleep, activity, readiness information, heart rate, heart rate variability, body temperature (delta), and respiratory rate. Additionally, the web-based platform will, through questionnaires, assess stress-related symptoms such as loneliness, anxiety, depression, and moral injury.

Interventions

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Digital Intervention Group

Participants will use a Digital Intervention Suite composed of a virtual reality (VR) scenario, a web-based platform, and a wearable device to assess their stress response in near-real time and in a hypothetical stressful scenario.

During the VR scenario, physiological signals such as Galvanic Skin Response (GSR), Electrocardiogram (ECG), Respiratory Independence (RI), and Photoplethysmography will be measured. Additionally, an educational intervention video on how to deal with stress and distress will be shown to participants. We will then request participants to practice the skills taught during the intervention video in the VR scenario.

The wearable device (Oura Ring) will measure sleep, activity, readiness information, heart rate, heart rate variability, body temperature (delta), and respiratory rate. Additionally, the web-based platform will, through questionnaires, assess stress-related symptoms such as loneliness, anxiety, depression, and moral injury.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University of Ontario Institute of Technology

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

University of Ottawa

OTHER

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Venkat Bhat, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Martin J, Rueda A, Lee GH, Tassone VK, Park H, Ivanov M, Darnell BC, Beavers L, Campbell DM, Nguyen B, Torres A, Jung H, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Interventions to Understand and Mitigate Stress Response: Protocol for Process and Content Evaluation of a Cohort Study. JMIR Res Protoc. 2024 May 6;13:e54180. doi: 10.2196/54180.

Reference Type DERIVED
PMID: 38709554 (View on PubMed)

Other Identifiers

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22-279

Identifier Type: -

Identifier Source: org_study_id

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