Rehabilitation Gaming System for Intensive Care Units

NCT ID: NCT06267911

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-12-31

Brief Summary

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 investigators 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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive stimulation and psychological support (RGS-ICU)

Group Type: EXPERIMENTAL

Cognitive stimulation and psychological support (RGS-ICU)

Intervention Type: OTHER

The RGS-ICU intervention consists of daily 20-minute sessions of early cognitive stimulation and psychological support adjuvant to standard ICU care administered by research staff and supervised by clinical staff each morning in the patient's own room during ICU admission and until ICU discharge or up to a maximum of 28 days after randomization. The sessions consist of orienting the patient to space and time, cognitive training of attention, working memory, learning/memory, executive function and processing speed, viewing of relaxing videos inspired by nature and fantasy scenarios to reduce stress and anxiety, and psychoeducation about the ICU environment and the characteristics of the cognitive, mental and physical state of critically ill patients.

Treatment as usual (TAU)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive stimulation and psychological support (RGS-ICU)

The RGS-ICU intervention consists of daily 20-minute sessions of early cognitive stimulation and psychological support adjuvant to standard ICU care administered by research staff and supervised by clinical staff each morning in the patient's own room during ICU admission and until ICU discharge or up to a maximum of 28 days after randomization. The sessions consist of orienting the patient to space and time, cognitive training of attention, working memory, learning/memory, executive function and processing speed, viewing of relaxing videos inspired by nature and fantasy scenarios to reduce stress and anxiety, and psychoeducation about the ICU environment and the characteristics of the cognitive, mental and physical state of critically ill patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years)
• Admitted to a medical/surgical ICU
• For respiratory failure, cardiogenic shock, or septic shock
• With an expected ICU stay of ≥48 hours
• Residing in Catalonia or Majorca (Balearic Islands)
• Who speak Catalan and/or Spanish
• Who are able to give informed consent by themselves or through an authorized representative

Exclusion Criteria

• History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder
• History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis
• History of brain damage, such as traumatic brain injury or stroke
• History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder
• Suspected or confirmed substance use disorder
• Suspected or confirmed communicable disease in an isolated patient
• Uncorrected hearing or visual impairment
• Any medical condition that prevents safe upper extremity mobility, such as skin lesions, burns, or fractures
• Life expectancy <12 months
• Enrolled in another trial that does not allow co-enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: collaborator

Hospital Son Llatzer

OTHER

Sponsor Role: collaborator

Fundació La Marató de TV3

OTHER

Sponsor Role: collaborator

University of the Balearic Islands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillem Navarra-Ventura, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Balearic Islands

Locations

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Corporacion Parc Tauli

Sabadell, Catalonia, Spain

Countries

Spain

References

Godoy-Gonzalez M, Lopez-Aguilar J, Fernandez-Gonzalo S, Goma G, Blanch L, Brandi S, Ramirez S, Blasi J, Verschure P, Rialp G, Roca M, Gili M, Jodar M, Navarra-Ventura G. Efficacy and safety of a non-immersive virtual reality-based neuropsychological intervention for cognitive stimulation and relaxation in patients with critical illness: study protocol of a randomized clinical trial (RGS-ICU). BMC Psychiatry. 2024 Dec 18;24(1):917. doi: 10.1186/s12888-024-06360-4.

Reference Type: BACKGROUND

PMID: 39696098 (View on PubMed)

Other Identifiers

160/U/2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202223-10

Identifier Type: -

Identifier Source: org_study_id