Evidence map›Paper›PMID 39696098›Full record

ArticleBMC psychiatry2024

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).

Marta Godoy-González, Josefina López-Aguilar, Sol Fernández-Gonzalo, Gemma Gomà, Lluís Blanch, Santiago Brandi, Sergi Ramírez, Joel Blasi, Paul Verschure, Gemma Rialp and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06267911 (Efficacy and Safety of a Non-immersive Virtual Reality-based Neuropsychological Intervention for Cognitive Stimulation and Psychological Support of Critical Care Patients), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06267911 naactive not recruitingnot on this map

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

TypeinterventionalSponsorUniversity of the Balearic IslandsRan2024 to 2026Enrolled93ConditionsCritical IllnessArmsCognitive stimulation and psychological support (RGS-ICU)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Marta Godoy-GonzálezCritical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
Josefina López-AguilarCritical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
Sol Fernández-GonzaloCritical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain. msfernandez@tauli.cat.
Gemma GomàCritical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
Lluís BlanchCritical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
Santiago BrandiEodyne Systems S.L, Barcelona, Spain.
Sergi RamírezEodyne Systems S.L, Barcelona, Spain.
Joel BlasiEodyne Systems S.L, Barcelona, Spain.
Paul VerschureCSIC Alicante Institute of Neuroscience and Department of Health Psychology, Universidad Miguel Hernández de Elche - UMH, Elche, Spain.
Gemma RialpCritical Care Department, Hospital Universitari Son Llàtzer, Palma, Spain.
Miquel RocaDepartment of Medicine, University of the Balearic Islands (UIB), Palma, Spain.
Margalida GiliHealth Research Institute of the Balearic Islands (IdISBa), Hospital Universitari Son Espases, Palma, Spain.
Mercè Jodar *Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Bellaterra, Spain.
Guillem Navarra-Ventura *Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain. g.navarra@uib.cat.

Funding

ACCIO Nuclis d'R+D empresarial RD17-1-0015CIBERES, ISCIII CB06/06/1097Marató de TV3 202223-10 (160/U/2022)
6 · The paper itself

Abstract

backgroundExperiencing a critical illness may be a stressful life event that is also associated with cognitive dysfunction during and after the intensive care unit (ICU) stay. A deep-tech solution based on non-immersive virtual reality, gamification and motion capture called Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) has been developed that includes both cognitive stimulation and relaxation protocols specifically designed for patients with critical illness. This study aims to evaluate whether the cognitive and relaxation protocols of the RGS-ICU platform are 1) effective in improving neuropsychological outcomes during and after ICU stay and 2) safe for patients with critical illness.

methodsThis is a study protocol for a multicenter longitudinal randomized clinical trial. At least 80 patients with critical illness will be included: 40 experimental subjects and 40 control subjects. Patients in the experimental group will receive daily 20-min sessions of cognitive stimulation and relaxation with the RGS-ICU platform adjuvant to standard ICU care in their own rooms during the ICU stay and until discharge from the ICU or up to a maximum of 28 days after randomization, provided they are alert and calm. Patients in the experimental group will be constantly monitored as part of standard ICU care to ensure the safety of the intervention and that no avoidable adverse events occur. Patients in the control group will receive standard ICU care. The primary outcome is objective cognition 12 months after ICU discharge, assessed with a composite index including measures of attention, working memory, learning/memory, executive function and processing speed. The secondary outcome is the safety of the intervention, assessed by considering the number of sessions terminated early due to unsafe events in physiological parameters. Other outcomes are comfort experienced during the ICU stay, and subjective cognition, mental health (anxiety, depression and post-traumatic stress disorder), functionality and health-related quality of life 12 months after ICU discharge. DISCUSSION: The expected results are 1) better neuropsychological outcomes during and after the ICU stay in patients in the experimental group compared to patients in the control group and 2) that the cognitive and relaxation protocols of the RGS-ICU platform are safe for patients with critical illness.

trial registrationClinicaltrials.gov NCT06267911. Registered on February 20, 2024.

Indexed as

Critical IllnessIntensive Care UnitsRelaxation TherapyVirtual RealityAdultCognitive Behavioral TherapyCognitive DysfunctionFemaleHumansLongitudinal StudiesMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeCognitionComfortCritical careCritical illnessIntensive care unitMental healthPost-intensive care syndromePreventionRehabilitationRelaxation

Identifiers

PMID39696098
PMCPMC11654385

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.