CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study
Trial ID: NCT05184725
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-01-10
Completion date: 2022-05-31
Sponsor: Adhera Health, Inc.
Collaborators: Maastricht University Medical Center; Hospital Sant Joan de Deu; Parc Taulí Hospital Universitari; Hospital Universitario Reina Sofia de Cordoba; Istituto Nazionale di Ricovero e Cura per Anziani
Conditions: Psychological Stress; Cardiopulmonary Bypass Surgery; Coronary Artery Bypass Surgery; Cardiac Valve Replacement; Hip Replacement; Orthognathic Surgery; Scoliosis; Knee Replacement; Prostate Cancer; Kidney Cancer; Bladder Cancer
Interventions: SaMD CARINAE
Locations: Istituto di Ricovero e Cura per Anziani; Maastricht University Medical Center; Hospital Reina Sofía; Hospital San Joan de Deu; Hospital Parc Taulí
Countries: Italy; Netherlands; Spain; Spain; Spain
Enrollment: 50
Age range: 8 Years - None
Sex: ALL

Summary:
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel. Interventions based on mobile health (mHealth) technologies, geared towards increasing familiarity with surgical procedures and hospital environments have been shown to help patients feel informed about possible benefits and risks of available treatment options. mHealth apps and Virtual Reality (VR) can offer patients experience in the perioperative environment that can be helpful in empowering patients and enhancing a more positive experience, while reducing stress. However, available applications focus only on providing informative content, neglecting the importance of patient empowerment with a more robust educational curriculum.

According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.

Eligibility criteria:
Inclusion Criteria:

* Patients planned for one of the selected surgery types:
* Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+)
* Coronary artery bypass surgery (Maastricht UMC+)
* Cardiac valve replacement (SAS, Maastricht UMC+)
* Prostate, kidney, and bladder cancer surgery (INRCA)
* Hip and knee replacement (HSJD; Parc Tauli)
* Maxillofacial surgery (HSJD)
* Orthognathic surgery (HSJD)
* Scoliosis (HSJD)
* Signed informed consent (by patient or legal guardian in paediatric cases).
* Patients ≥ 18 years old, except for paediatric Hospital San Joan de Deu (HSJD) ≥ 8 years old.
* Patient owns a smartphone with Android version 4.4 or above.
* Patient (or legal guardian/caregiver in paediatric cases) is able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar).

Exclusion Criteria:

* Dementia.
* Pregnant women.
* Inability to understand the local language.
* Allergic to dedicated wearable material (stainless steel and silicone).
* Currently enrolled in a different clinical trial.

Outcomes:
Visual Analog Scale for Stress; Visual Analog Scale for Pain; Hospital Anxiety and Depression Scale; Health-related Quality of Life - EQ-5D-3L/-Y; The Positive and Negative Affect Schedule; The Short Warwick-Edinburgh Mental Well-Being Scale; General Self-Efficacy Scale; Patient Activation Measure