CARINAE for Stress Relief in Perioperative Care

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.

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

DEVICE

SaMD CARINAE

SaMD CARINAE delivers the following digital therapeutic intervention to the patients: 1) Personalised patient-centred health education program to improve patient's disease and recovery self-management skills. 2) AI-based behaviour change program to promote healthier lifestyle habits. 3) Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety. 4) A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals.

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Hospital Sant Joan de Deu

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Istituto Nazionale di Ricovero e Cura per Anziani

  collaborator OTHER

• Adhera Health, Inc.

  lead INDUSTRY

Principal Investigators

• Clara Hernández Cera · Hospital San Joan de Deu

• Ignacio Muñoz Carvajal · Hospital Universitario Reina Sofía

• Juan José Lázaro Alcay · Hospital San Joan de Deu

• Andrea Vallejo Tarrat · Parc Taulí Hospital Universitari

• JG Maessen, Prof. dr. · Maastricht University Medical Center

• Marco Dellabella · Istituto di Ricovero e Cura per Anziani

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-10

Primary Completion

2022-04-30

Completion

2022-05-31

Countries

• Italy
• Netherlands
• Spain

Study Locations