A Digital Health Intervention for Stress and Anxiety Relief in Perioperative Care: Protocol for a Feasibility Randomized Controlled Trial.

Autor:	Kondylakis H; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece., Chicchi Giglioli IA; Adhera Health, Inc, Palo Alto, CA, United States., Katehakis DG; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece., Aldemir H; Digital Health Program, Barcelona Technology School, Barcelona University, Barcelona, Spain., Zikas P; ORamaVR SA, Heraklion, Greece., Papagiannakis G; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece.; Department of Computer Science, University of Crete, Heraklion, Greece., Hors-Fraile S; Adhera Health, Inc, Palo Alto, CA, United States., González-Sanz PL; Adhera Health, Inc, Palo Alto, CA, United States., Apostolakis KC; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece., Stephanidis C; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece.; Department of Computer Science, University of Crete, Heraklion, Greece., Núñez-Benjumea FJ; Virgen Macarena University Hospital, Andalusian Health Service, Sevilla, Spain., Baños-Rivera RM; Polibienestar Institute, University of Valencia, Valencia, Spain.; CiberObn Pathophysiology of Obesity and Nutrition (CB06/03), Instituto Salud Carlos III, Madrid, Spain., Fernandez-Luque L; Adhera Health, Inc, Palo Alto, CA, United States., Kouroubali A; Institute of Computer Science, Foundation for Research and Technology (FORTH), Heraklion, Greece.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2022 Nov 29; Vol. 11 (11), pp. e38536. Date of Electronic Publication: 2022 Nov 29.
DOI:	10.2196/38536
Abstrakt:	Background: Stress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment. Objective: This study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program 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 standard care, and the intervention group will additionally be exposed to the digital health intervention program. Results: The recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023. Conclusions: This manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery. Trial Registration: ClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725. International Registered Report Identifier (irrid): DERR1-10.2196/38536. (©Haridimos Kondylakis, Irene Alice Chicchi Giglioli, Dimitrios G Katehakis, Hatice Aldemir, Paul Zikas, George Papagiannakis, Santiago Hors-Fraile, Pedro L González-Sanz, Konstantinos C Apostolakis, Constantine Stephanidis, Francisco J Núñez-Benjumea, Rosa M Baños-Rivera, Luis Fernandez-Luque, Angelina Kouroubali. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.11.2022.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu