protocolSection identificationModule nctId: NCT06267911, orgStudyIdInfo id: 202223-10, secondaryIdInfos id: 160/U/2022, type: OTHER_GRANT, domain: Fundació La Marató de TV3, briefTitle: Rehabilitation Gaming System for Intensive Care Units, acronym: RGS-ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of the Balearic Islands, class: OTHER, collaborators name: Corporacion Parc Tauli, collaborators name: Hospital Son Llatzer, collaborators name: Fundació La Marató de TV3, descriptionModule briefSummary: Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders., conditionsModule conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive stimulation and psychological support (RGS-ICU), outcomesModule primaryOutcomes measure: Attention performance, primaryOutcomes measure: Working memory performance, primaryOutcomes measure: Learning/memory performance, primaryOutcomes measure: Executive function performance, primaryOutcomes measure: Processing speed performance, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety], secondaryOutcomes measure: Dyspnea intensity, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Worry intensity, secondaryOutcomes measure: Sadness intensity, secondaryOutcomes measure: Comfort experienced, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Symptoms of depression, secondaryOutcomes measure: Symptoms of post-traumatic stress disorder, otherOutcomes measure: Subjective cognition, otherOutcomes measure: Functionality, otherOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of the Balearic Islands, city: Palma De Mallorca, state: Balearic Islands, zip: 07122, country: Spain, contacts name: Guillem Navarra-Ventura, PhD, role: CONTACT, phone: +34971259888, email: g.navarra@uib.es, geoPoint lat: 39.56939, lon: 2.65024, locations facility: Hospital Universitari Son Llàtzer, city: Palma De Mallorca, state: Balearic Islands, zip: 07198, country: Spain, contacts name: Gemma Rialp, MD, PhD, role: CONTACT, phone: +34871202000, email: grialp@ssib.es, geoPoint lat: 39.56939, lon: 2.65024, locations facility: Corporacion Parc Tauli, city: Sabadell, state: Catalonia, zip: 08208, country: Spain, contacts name: Sol Fernández-Gonzalo, PhD, role: CONTACT, phone: +34937236673, email: msfernandez@tauli.cat, geoPoint lat: 41.54329, lon: 2.10942, hasResults: False