Using a gaming system to support ICU patients' mental health

Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients

This study tests whether a gaming system can help improve the mental health and comfort of patients in the ICU while they recover.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of the Balearic Islands (Academic / other)
• Locations: 3 sites (Palma De Mallorca, Balearic Islands and 2 other locations)
• Trial ID: NCT06267911 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU), an innovative e-health intervention designed to provide cognitive stimulation and psychological support to patients in critical care. The intervention utilizes non-immersive virtual reality techniques to enhance comfort during ICU admission and improve cognitive and mental health outcomes three and twelve months post-discharge. It is administered alongside standard ICU care to address the psychological challenges faced by critically ill patients.

Who should consider this trial

Good fit: Ideal candidates include adult patients (18 years and older) admitted to a medical or surgical ICU for respiratory failure, cardiogenic shock, or septic shock, who are expected to stay in the ICU for at least 48 hours.

Not a fit: Patients with a history of severe psychiatric illness, neurodevelopmental disorders, or significant neurological conditions may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and cognitive recovery of ICU patients, reducing the long-term effects of Post-Intensive Care Syndrome.

How similar studies have performed: While the use of virtual reality in healthcare is gaining traction, this specific approach for ICU patients is relatively novel and has not been extensively tested in similar studies.

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

Where this trial is running

Palma De Mallorca, Balearic Islands and 2 other locations

• University of the Balearic Islands — Palma De Mallorca, Balearic Islands, Spain (Active_not_recruiting)
• Hospital Universitari Son Llàtzer — Palma De Mallorca, Balearic Islands, Spain (Recruiting)
• Corporacion Parc Tauli — Sabadell, Catalonia, Spain (Recruiting)

Study contacts

• Principal investigator: Guillem Navarra-Ventura, PhD — University of the Balearic Islands
• Study coordinator: Guillem Navarra-Ventura, PhD

Conditions Critical Illness