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Spots Global Cancer Trial Database for CARINAE for Stress Relief in Perioperative Care

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Trial Identification

Brief Title: CARINAE for Stress Relief in Perioperative Care

Official Title: CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study

Study ID: NCT05184725

Interventions

SaMD CARINAE

Study Description

Brief 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.

Detailed Description: Patients will be randomly assigned to intervention group or the control group. Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately. The intervention trial will include a total of 4 visits: 1. Recruitment; 2. Hospital admission; 3. Hospital discharge; 4. Post-operative follow-up in 14 days. SaMD CARINAE delivers the following interventions to the patients: * Personalised patient-centred health education program to improve patient's condition and recovery self-management skills. * Artificial Intelligence-based behaviour change program to promote healthier lifestyle habits. * Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety. * A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals. The program is delivered to patients and caregivers as a SaMD mHealth application (smartphone app) and an immersive environment with a VR device. Healthcare professionals will be able to access the collaborative digital support platform through a web application. Finally, the control group will not be exposed to SaMD CARINAE solution, following the traditional routine visits, and after each traditional visit patients will answer to questionnaires specified in the secondary outcome measures section.

Eligibility

Minimum Age: 8 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Istituto di Ricovero e Cura per Anziani, Ancona, , Italy

Maastricht University Medical Center, Maastricht, , Netherlands

Hospital Reina Sofía, Córdoba, Andalucía, Spain

Hospital San Joan de Deu, Esplugues De Llobregat, Catalunya, Spain

Hospital Parc Taulí, Sabadell, Catalunya, Spain

Contact Details

Name: Clara Hernández Cera

Affiliation: Hospital San Joan de Deu

Role: PRINCIPAL_INVESTIGATOR

Name: Ignacio Muñoz Carvajal

Affiliation: Hospital Universitario Reina Sofía

Role: STUDY_DIRECTOR

Name: Juan José Lázaro Alcay

Affiliation: Hospital San Joan de Deu

Role: STUDY_CHAIR

Name: Andrea Vallejo Tarrat

Affiliation: Parc Taulí Hospital Universitari

Role: STUDY_CHAIR

Name: JG Maessen, Prof. dr.

Affiliation: Maastricht University Medical Center

Role: STUDY_CHAIR

Name: Marco Dellabella

Affiliation: Istituto di Ricovero e Cura per Anziani

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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