A Digital Health Intervention for Stress and Anxiety Relief in Perioperative Care: Protocol for a Feasibility Trial. (Preprint)

BACKGROUND Stress and anxiety are psychophysiological responses commonly experienced by patients during a perioperative process that can increase pre- and post-surgical complications to a comprehensive and positive recovery. Preventing and intervening stress and anxiety can help patients achieve positive outcomes on health and wellbeing. Similarly, provision of education about the surgery can be a crucial component and it is inversely correlated to preoperative anxiety levels. However, few patients receive stress and anxiety relief support prior to a surgery and, resource constraints make face-to-face education sessions untenable. Digital health (DH) interventions can be helpful in empowering patients and enhancing a more positive experience. DH interventions are showing to help patients feel informed about possible benefits and risks of available treatment options. However, currently they focus only on providing informative content, neglecting the importance of personalization and patient empowerment. OBJECTIVE This study aims to explore the feasibility of a DH intervention called CARINAE designed to provide personalized stress- and anxiety-management evidence-based methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile and virtual reality technologies. CARINAE includes the use of advanced data-driven techniques for tailored patient education and lifestyle support. METHODS The trial will include 5 hospitals across 3 European countries, and will use a randomized-controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive the standard care and the intervention group will additionally be exposed to the CARINAE intervention. RESULTS The recruitment process starts by January 2022, and the primary impact analysis is expected to be conducted by May 2022. CONCLUSIONS This manuscript details a comprehensive protocol for a study that will provide valuable information about the CARINAE intervention such as the measurement of comparative intervention effects on stress, anxiety and pain management and usability by patients, caregivers and healthcare professionals. This will contribute to the evidence planning process for the future adoption of diverse DH solutions in the surgery field. CLINICALTRIAL Trial was registered in ClinicalTrials.gov: NCT05184725.