Critical IllnessRGS-ICUNCT06267911
Rehabilitation Gaming System for Intensive Care Units
A study testing Cognitive stimulation and psychological support (RGS-ICU) in people with Critical Illness, run by University of the Balearic Islands at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Cognitive stimulation and psychological support (RGS-ICU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
Hospital Universitari Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Corporacion Parc Tauli
Sabadell, Catalonia, 08208
About this study
Official title: Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients
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.
Read more
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
- Being tested
- Cognitive stimulation and psychological support (RGS-ICU)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation and psychological support (RGS-ICU)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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive stimulation and psychological support (RGS-ICU) | Experimental | Not described Receives: Other: Cognitive stimulation and psychological support (RGS-ICU) |
| Treatment as usual (TAU) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention performance
Difference in attention performance (Z scores) between experimental and non-intervention groups assessed with the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Forward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better attention performance.
Measured: 12 months after discharge from the ICU
Working memory performance
Difference in working memory performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Backward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better working memory performance.
Measured: 12 months after discharge from the ICU
Learning/memory performance
Difference in learning/memory performance (Z scores) between experimental and non-intervention groups assessed with the Rey Auditory Verbal Learning Test (RAVLT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better learning/memory performance.
Measured: 12 months after discharge from the ICU
Executive function performance
Difference in executive function performance (Z scores) between experimental and non-intervention groups assessed with the Trail Making Test (TMT), the Stroop Color and Word Test (SCWT), and the verbal phonemic fluency (FAS) test 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Measured: 12 months after discharge from the ICU
Processing speed performance
Difference in processing speed performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Digit Symbol-Coding subtest and the Symbol Digit Modalities Test (SDMT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Measured: 12 months after discharge from the ICU
Incidence of Treatment-Emergent Adverse Events [Safety]
Number of interrupted sessions due to adverse events in the patients' physiological parameters (oxygen saturation, respiratory rate and heart rate) during admission to the ICU. The higher the number of interrupted sessions, the less safe the intervention.
Measured: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Secondary outcomes (8)
Dyspnea intensity
Change in dyspnea intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense dyspnea.
Measured: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Pain intensity
Change in pain intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense pain.
Measured: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Worry intensity
Change in worry intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense worry.
Measured: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Sadness intensity
Change in sadness intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense sadness.
Measured: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Comfort experienced
Difference in experienced comfort between experimental and non-intervention groups assessed with the Patient Evaluation of Emotional Comfort Experienced (PEECE) questionnaire at ICU discharge, a 12-item instrument with range 0-48. Higher scores indicate better subjective psychological well-being.
Measured: Discharge from the ICU
Anxiety symptoms
Difference in anxiety symptoms between experimental and non-intervention groups assessed with the Generalized Anxiety Disorder (GAD-7) questionnaire 12 months after ICU discharge, a 7-item instrument with range 0-21. Higher scores indicate more severe anxiety symptoms.
Measured: 12 months after discharge from the ICU
Symptoms of depression
Difference in symptoms of depression between experimental and non-intervention groups assessed with the Patient Health Questionnaire-9 (PHQ-9) 12 months after ICU discharge, a 9-item instrument with range 0-27. Higher scores indicate more severe symptoms of depression.
Measured: 12 months after discharge from the ICU
Symptoms of post-traumatic stress disorder
Difference in post-traumatic stress disorder symptoms between experimental and non-intervention groups assessed with the Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) 12 months after ICU discharge, a 8-item instrument with range 0-32. Higher scores indicate more severe symptoms of post-traumatic stress disorder.
Measured: 12 months after discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli, Hospital Son Llatzer, Fundació La Marató de TV3
- Responsible party
- Sponsor
- Investigators
- Guillem Navarra-Ventura, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267911
- Sponsor's protocol ID
- 202223-10
- Other IDs
- 160/U/2022
- Acronym
- RGS-ICU
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39696098
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients
- ClinicalTrials.gov ID
- NCT06267911
- Acronym / sponsor ID
- RGS-ICU / 202223-10
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli, Hospital Son Llatzer, Fundació La Marató de TV3
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive stimulation and psychological support (RGS-ICU) | Experimental | Other: Cognitive stimulation and psychological support (RGS-ICU) |
| Treatment as usual (TAU) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cognitive stimulation and psychological support (RGS-ICU) |
Primary outcome
Attention performance
Time frame: 12 months after discharge from the ICU
Difference in attention performance (Z scores) between experimental and non-intervention groups assessed with the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Forward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better attention performance.
Working memory performance
Time frame: 12 months after discharge from the ICU
Difference in working memory performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Backward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better working memory performance.
Learning/memory performance
Time frame: 12 months after discharge from the ICU
Difference in learning/memory performance (Z scores) between experimental and non-intervention groups assessed with the Rey Auditory Verbal Learning Test (RAVLT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better learning/memory performance.
Executive function performance
Time frame: 12 months after discharge from the ICU
Difference in executive function performance (Z scores) between experimental and non-intervention groups assessed with the Trail Making Test (TMT), the Stroop Color and Word Test (SCWT), and the verbal phonemic fluency (FAS) test 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Processing speed performance
Time frame: 12 months after discharge from the ICU
Difference in processing speed performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Digit Symbol-Coding subtest and the Symbol Digit Modalities Test (SDMT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Number of interrupted sessions due to adverse events in the patients' physiological parameters (oxygen saturation, respiratory rate and heart rate) during admission to the ICU. The higher the number of interrupted sessions, the less safe the intervention.
8 secondary outcomes
Dyspnea intensity
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Pain intensity
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Worry intensity
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Sadness intensity
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Comfort experienced
Time frame: Discharge from the ICU
Anxiety symptoms
Time frame: 12 months after discharge from the ICU
Symptoms of depression
Time frame: 12 months after discharge from the ICU
Symptoms of post-traumatic stress disorder
Time frame: 12 months after discharge from the ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 39696098Godoy-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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Navarra-Ventura, PhD principal investigator
University of the Balearic Islands
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation and psychological support (RGS-ICU) in people with Critical Illness, run by University of the Balearic Islands at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention performance (time frame: 12 months after discharge from the ICU). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06267911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.