NCT05923398|Completed
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Sponsor study identifier
interventional
100
1 country
1
Study Start
May 1, 2023
Actual (reported)Primary Completion
December 8, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2022
Actual (reported)May 1, 2023
Actual (reported)June 28, 2023
Actual (reported)December 8, 2023
Actual (reported)December 8, 2023
Actual (reported)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.
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Rueda A, Martin J, Parkington K, Perivolaris A, Teferra BG, Lee GH, Tassone VK, Lin Q, Ivanov M, Darnell B, Beavers L, Campbell DM, Torres A, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Health Monitoring and Intervention Suite for Stress in Frontline Nurses: Prospective Cohort Trial. JMIR Form Res. 2026 Jun 11;10:e77818. doi: 10.2196/77818.
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.
Venkat Bhat, MD MSc
Unity Health Toronto
100 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2022
Approximately 3.5 months
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
Contact the study team to confirm eligibility.
First Posted
June 28, 2023
Study Start
May 1, 2023
Actual (reported)Primary Completion
December 8, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)Last Updated
February 14, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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