Digital Interventions to Understand and Mitigate Stress Response

NCT05923398 | Completed

• 1 other identifier: 22-279
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Subjective Units of Distress Scale (SUDS)

  The primary outcome will be the change in SUDS scores from (1) beginning to end of VR and (2) baseline to end of follow-up. The SUDS is an instrument (visualized as a fear thermometer) that ranges from scores of 0 to 100. It measures the intensity of emotions and other internal experiences, such as anxiety, anger, agitation, tension, and other painful emotions. Participants will complete SUDS before the VR scenario starts and once the VR scenario is over. Additionally, participants will complete the SUDS for a total of 8 times when in the VR scenario. Participants will also answer the SUDS using the web-based platform every week on Mondays, Thursdays, and Saturdays for approximately 3.5 months.

  Approximately 3.5 months

• Moral Injury Outcome Scale (MIOS-4; 4 item scale)

  The primary outcome will be the change in MIOS-4 scores from (1) beginning to end of VR and (2) baseline to end of follow-up. MIOS-4 is a short version of the MIOS-14. The 4 items have scores that range 0 (strongly disagree) to 4 (strongly agree); Total score ranges from 0 - 16. The MIOS is intended to measure the severity of moral injury outcomes as a result of a potentially morally damaging experience. Participants will complete the MIOS-4 during the VR scenario for a total of 8 times. Additionally, participants will answer the MIOS-4 using the web-based platform every week on Mondays and Thursdays for approximately 3.5 months.

  Approximately 3.5 months

Secondary Outcomes (6)

• UCLA Loneliness Scale (3 item scale)

  Approximately 3.5 months

• Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)

  Approximately 3.5 months

• Generalized Anxiety Disorder Scale (GAD-2; 2 item scale)

  Approximately 3.5 months

• Patient Health Questionnaire (PHQ-9; 9 item scale)

  Approximately 3.5 months

• Patient Health Questionnaire (PHQ-2; 2 item scale)

  Approximately 3.5 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

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).

Behavioral: Digital Intervention Group

Interventions

Digital Intervention Group 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Toronto Metropolitan University: collaborator
• University of Toronto: collaborator
• University of Ontario Institute of Technology: collaborator
• Boston University: collaborator
• University of Ottawa: collaborator
• Western University, Canada: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38709554 DERIVED

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; COVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Venkat Bhat, MD MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: June 28, 2023
• Study Start: May 1, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)