Stress Reduction in Perioperative Care: Feasibility Randomized Controlled Trial
Authors: Kondylakis Haridimos , Giglioli Irene Alice Chicchi , Katehakis Dimitrios , Aldemir Hatice , Zikas Paul , Papagiannakis George , Hors-Fraile Santiago , González-Sanz Pedro L , Apostolakis Konstantinos , Stephanidis Constantine , Núñez-Benjumea Francisco J , Baños-Rivera Rosa M , Fernandez-Luque Luis , Kouroubali Angelina 
Published: January 2025

Background
Patients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support.

Objective
This study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support.

Methods
A total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress.

Results
The intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions.

Conclusions
Our results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication.

Trial Registration
ClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725

International Registered Report Identifier (IRRID)
RR2-10.2196/38536