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Wearable-Enhanced Care to Assist stress Regulation and Empowerment in emergency care settings (The WeCare Study).

Optimising stress regulation and resilience with wearable devices in emergency care settings: a single-case experimental study with replication.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001354471
Acronym
The WeCare Study
Enrollment
32
Registered
2025-12-03
Start date
2026-01-15
Completion date
2027-06-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Emergency care settings are high-stress environments that affect both patients and healthcare workers, with acute stress responses influencing recovery, morbidity, and long-term mental health. If unmanaged, physiological stress reactions can escalate into chronic conditions such as PTSD, depression, and anxiety. This study evaluates the WeCare program, a wearable-integrated stress management intervention that provides real-time physiological feedback to enhance self-regulation and resilience. Using a single-case experimental design, the WeCare program will be tested for feasibility, effectiveness, and economic impact across four vulnerable groups: (i) mild-to-moderately injured patients, (ii) severely injured patients, (iii) individuals with acute medical symptoms, and (iv) emergency healthcare workers. Findings will inform scalable, early interventions to improve mental well-being and health outcomes in emergency care settings.

Interventions

The intervention is a 6-week wearable-based stress regulation and resilience program (WeCare program), using a smart ring to track real-time biometric information, including heart rate, sleep and stress patterns, and breathing activity. The program guides individuals through a personalised, stepped process of self-awareness and lifestyle behaviour changes, including an initial education session, weekly telephone check-ins, and optional activities aimed at enhancing stress management and resilien

The intervention is a 6-week wearable-based stress regulation and resilience program (WeCare program), using a smart ring to track real-time biometric information, including heart rate, sleep and stress patterns, and breathing activity. The program guides individuals through a personalised, stepped process of self-awareness and lifestyle behaviour changes, including an initial education session, weekly telephone check-ins, and optional activities aimed at enhancing stress management and resilience via the smartphone app. Participants use the app to access real-time biometric insights, track progress with activity logbooks, and engage in self-reflection journaling, while weekly email updates provide insights and recommendations to encourage lifestyle modifications. Self-regulation techniques, such as breathwork and meditation, are also available through the app. The initial education session introduces participants to the multidimensional nature of stress and wellbeing, including its physiological manifestations. Participants are introduced to the smart ring, instructed on installation of the app, and begin continuous data and daily activity tracking. They also receive an overview of the WeCare program and guidance on how to use the smart ring and app effectively, with the goal of building foundational awareness and context-specific understanding of stress and wellbeing. This session is conducted by a research assistant or research fellow with a psychology and/or medical background. Weekly telephone check-ins are conducted by the same research assistant/research fellow and are designed to monitor progress, address participant questions, and provide personalised support. Participants may choose to share their biometric data from the smart ring in advance to guide the discussion and tailor feedback, supporting engagement with the program and encouraging lifestyle modifications. Participants are also encouraged to explore optional self-regulation strategies through the app, such as breathwork and mindfulness modules, and integrate healthy habits and reflection practices into their daily routines. Participants are asked to check the app at least upon waking each day to review their health metrics and on some days in the evening or during the day to complete reflection activities. Engagement beyond these minimum touchpoints is encouraged but not mandated, allowing flexibility to explore additional features as suited to individual routines. Biometric data can be viewed directly through the app linked to the smart ring. Adherence and engagement are monitored via smart ring wear time, app usage analytics from the digital health platform, and participant feedback, which inform assessment of program fidelity and adherence to intervention components. Following the main 6-week program, participants can opt for a 2-week extension phase to experience the intervention delivered via a smartwatch instead of a smart ring, providing an alternative delivery method. This phase is an integral part of the “acceptability” evaluation conducted during the co-design component and is not intended to test effectiveness. Therefore, there are no weekly telephone check-ins or specific optional activities for this period. Participants will, however, have access to in-built breathwork and mindfulness modules within the smartwatch to support stress management and resilience. There are some differences in device use between the smart ring and the smartwatch. Participants using the smart ring can view their biometric data (e.g., sleep, heart rate, recovery indicators) through the associated smartphone app, which also integrates reflection and wellbeing tracking features. In contrast, participants using the smartwatch can view basic real-time metrics (e.g., heart rate, activity) directly on the device, with more detailed summaries accessible via the paired smartphone app.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

The study include four samples of participants, comprising individuals exposed to severe stress in emergency care settings. This involves 3-8 eligible participants per sample (at least 3 participants per experiment), resulting in a total of up to 32 participants. These samples include: (1) Sample 1: those seeking emergency care for mild-to-moderate acute injuries; (2) Sample 2: those seeking emergency care for severe acute injuries; (3) Sample 3: those seeking emergency care for mild-to-moderate acute medical complaints; and (4) Sample 4: healthcare professionals working in Emergency care settings. Participants will be included if: All participants • Aged 18-70 years • Sufficient English proficiency • Willing to wear a smart watch and/or a smart ring device for at least 22 hours for the next 3 months Sample 1: Mild-to moderate injured participants • Sustained in last 2 weeks, a minor-to-moderate traumatic injury due to non-violent cause (e.g., traffic crash, fall, work-related), such as a whiplash injury, minor fractures, limb fractures, joint sprains or strains. • Presented to RNSH emergency department (ED), Sydney, Australia • Injury Severity Score less than 15 Sample 2: Severe injured participants • Sustained in last 4 weeks, a severe traumatic injury due to non-violent cause (e.g., traffic crash, fall, work-related), such as multi-trauma or severe injuries requiring aggressive therapy and/or admission to Intensive Care Unit (ICU) • Presented to RNSH emergency department, Sydney, Australia • Injury Severity Score greater than or equal to 15 Sample 3: Medical participants • Acute onset of medical symptoms of minor-to-moderate severity, such as musculoskeletal symptoms (e.g., back pain, neck pain), gastrointestinal symptoms (e.g., abdominal pain, nausea), urinary symptoms (e.g., urinary tract infections); respiratory symptoms (e.g., mild shortness of breath, persistent cough) or migraine, prompting a visit to the Emergency Department (ED) for evaluation and care. • Presented to RNSH emergency department (ED), Sydney, Australia. • Received an Australasian Triage Scale (ATS) category 3–5= less urgent, requiring standard treatment home or inpatient non-ICU. Sample 4: ED health workers participants • Being a healthcare worker at the Emergency Department of Royal North Shore Hospital (RNSH), Sydney, Australia, including including clinical and non-clinical staff

Exclusion criteria

Participants will be excluded if: All participants • History or evidence of substance abuse (e.g., alcohol, illicit drugs) at the time of admission. • History of severe mental health disorders, e.g. bipolar disorder or psychoses or chronic depression disorder, determined by medical history or psychiatric interview. • History of unstable or poorly controlled cardiovascular, neurological, or other serious systemic disease that is likely to interfere with study evaluation or participant safety (e.g., uncontrolled blood pressure, unstable arrhythmia, decompensated heart failure, recent myocardial infarction or stroke, new or uncontrolled metabolic or inflammatory conditions). • Evidence of any conditions (e.g., cognitive disorder, dementia) that interfere with the patient’s ability to understand the requirements of the study and their ability to consent • Taking cardioactive medication (e.g., antihypertensive, antidepressants, antipsychotics, antihistamines, ß-agonists) that affects cardiovascular system and study outcome (e.g., HRV) • Undergoing, or planning to undergo, surgery or inpatient admission/ hospitalisation during the next three months. Sample 1: Mild-to moderate injured participants • Injuries due to violent causes, such as assaults or self-arm • Injuries involving the brain • Very minor, localised, superficial soft-tissue injuries, such as small cuts, abrasions, minor bruises, or localised swelling Sample 2: Severe injured participants • Injuries due to violent causes, such as assaults or self-harm • Injuries involving the brain • Catastrophic injuries as defined by NSW lifetime care, that is, a very severe traumatic brain injury, a spinal cord injury, extensive burns to the body (>60%), major amputation or blindness Sample 3: Medical participants • Requiring aggressive or palliative treatment, intubation or ICU admission. Sample 4: ED healthcare workers participants • History of injury requiring ED presentation or exposure to a traumatic event (i.e., perceived threat of injury to self or others) in the past year. • Presented to the ED or admitted to hospital in the past year.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026