Virtual Reality for Recovery After Intensive Care (PICS) (VR4ICU)
8 de maio de 2026 atualizado por: Adriana Sampaio, University of Minho
Virtual Reality Intervention for Post-Intensive Care Syndrome (PICS): A Protocol for a Pilot Randomized Controlled Trial for Cognitive, Physical and Psychological Outcomes
The goal of this clinical trial is to learn if virtual reality (VR) helps improve thinking and memory skills in adults who have stayed in the intensive care unit (ICU). The study focuses on people who needed a breathing machine or stayed in the ICU for several days and are at risk for memory or "brain fog" issues.
The main questions it aims to answer are:
- Does using VR improve a participant's memory, attention, and thinking skills after an ICU stay?
- Does the "immersive" feel of a VR headset work better to improve these skills than using a handheld tablet?
Researchers will compare three groups to see how different types of care affect the brain:
- VR-Rehab: Participants use a VR headset to play brain-training games.
- Tablet-Rehab: Participants use a handheld tablet to play the same brain-training games.
- Standard Care: Participants receive the usual hospital care without digital brain games.
Participants will:
- Play brain-training games for 12 minutes every day for up to one week while in the hospital.
- Complete memory and thinking tests with a researcher at the start of the study and again after two weeks.
- Answer follow-up questions about their memory and thinking skills for 6 months after leaving the hospital.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
Study Rationale and the Immersion Hypothesis Survivors of critical illness often face significant cognitive impairments, a key component of Post-Intensive Care Syndrome (PICS). While early rehabilitation is recommended, traditional methods often struggle to address cognitive recovery in the acute ICU setting.
This trial is designed to investigate the "Immersion Hypothesis." This hypothesis suggests that the neurological engagement provided by a fully immersive virtual reality (VR) environment offers superior cognitive benefits compared to standard digital content delivered via a 2D interface. By utilizing a three-arm randomized design, the study seeks to isolate whether the therapeutic value comes from the digital exercises themselves or the physiological and psychological impact of total immersion.
Study Design and Arms
Participants are randomized into one of three parallel groups with a 1:1:1 allocation ratio:
- VR-Based Rehabilitation (VR-Rehab): Participants use a Meta Quest Pro head-mounted display (HMD) to engage in the Enhance VR platform (Virtuleap). This involves 6 specific games targeting information processing, problem-solving, attention, memory, and motor control.
- Tablet-Based Rehabilitation (Tablet-Rehab): Participants engage in the exact same cognitive exercises and gameplay durations as the VR group, but via a 2D tablet interface. This arm serves as a "digital control" to account for the effects of cognitive stimulation without immersion.
- Standard of Care (SOC): Participants receive conventional ICU rehabilitation, including physical and respiratory physiotherapy, without structured digital cognitive training.
Intervention Protocol All digital interventions are performed at the bedside with the participant positioned at a 30° to 60° angle for safety. Sessions are designed for a target "dose" of 12 minutes of active gameplay per day for up to 7 consecutive days (or until ICU discharge).
A "Minimum Therapeutic Dose" is defined for this study as the successful completion of at least 12 individual game sessions. This threshold ensures that participants have reached a level of engagement sufficient to evaluate the impact of the technology on cognitive recovery.
Procedural Rigor and Bias Mitigation
To ensure high-quality data in a non-blinded clinical environment, the trial enforces a strict separation of duties:
- Researcher Roles: Different researchers facilitate the daily intervention sessions and conduct the primary cognitive assessments. Those delivering the VR or Tablet therapy are prohibited from scoring the recovery outcomes.
- Automated Analysis: To eliminate subjective interpretation, primary group comparisons are performed using pre-developed, automated scripts in Python.
- Sanitization: Strict infection control protocols are followed, using medical-grade, non-corrosive disinfectant wipes for all hardware between uses.
Safety Monitoring Participant safety is monitored continuously during every session. Predefined stop criteria include physiological instability (such as a drop in oxygen saturation or significant changes in heart rate) or any verbal/non-verbal signs of distress or "cybersickness."
Tipo de estudo
Intervencional
Inscrição (Estimado)
51
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nuno F. Rodrigues
- Número de telefone: +351 929145931
- E-mail: nunofeixa@gmail.com
Estude backup de contato
- Nome: Inês Oliveira
- Número de telefone: +351 965796047
- E-mail: ines.t.oliveira@gmail.com
Locais de estudo
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Porto District
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Porto, Porto District, Portugal, 4200-319
- Recrutamento
- Centro Hospitalar Universitário São João
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Contato:
- João Ferreira-Coimbra, MD
- Número de telefone: +351 912712480
- E-mail: joaoferreiracoimbra@gmail.com
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Investigador principal:
- João Ferreira-Coimbra, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Adult patients, 18 years or older
- Patients in the Intensive Care Unit
- Ventilated patients must be in the post-extubation period
- The patient has a projected remaining hospital stay of at least 4 days (assessed by the clinical team)
- The patient has RASS score between -1 and +1
- The patient has the ability to move both arms, even if with difficulties, as assessed by the clinical team, to be able to interact with the software
- The patient can maintain a stable sitting position (30° to 60°)
- The patient is able to communicate (speech, gesturing, or writing)
- The patient can communicate and understand Portuguese
- The patient or a legal representative provided informed consent
Exclusion Criteria:
- Severe cognitive and neurodegenerative diseases: mental illness requiring institutionalization; acquired or congenital intellectual disability; known severe brain injuries (e.g., stroke with significant residual deficits); moderate to severe Traumatic Brain Injury (TBI) (defined by the duration of loss of consciousness/post-traumatic amnesia or documented residual deficits); diagnosed neurodegenerative diseases (e.g., Parkinson's disease with severe movement impairment, Huntington's disease, severe Alzheimer's disease, or dementia of any etiology that prevents autonomy in daily life at baseline)
- The patient uses neuromuscular blocking agents
- The patient has a positive CAM-ICU result at the time of initial screening
- The patient has active psychotic disorders or suicidal ideation
- The patient has documented epilepsy or history of seizures
- The patient has a "Do Not Resuscitate" (DNR) order, is on life support with exclusive focus on comfort, or has an unexpected survival predicted to be less than 24 hours
- The patient has intoxication by an active substance or withdrawal syndrome requiring ongoing medical management that prevents safe and meaningful participation or accurate cognitive assessment
- Patients with immobility or severe motor limitations in the upper limbs, fine motor skills, or cervical region
- The patient has open wounds on the head or face that may affect the comfortable/safe use of VR glasses, cause discomfort, or present a hygiene risk
- The patient has uncorrected blindness or deafness that prevents the safe/effective use of VR/tablet devices.
- Patients are participating in another rehabilitation study with interventions
- Patients with a scheduled surgery where the ICU stay is expected to be less than 24 hours
- Patients in need of respiratory support
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: VR-Based Rehabilitation (VR-Rehab)
Participants receive immersive cognitive training using the Meta Quest Pro headset and the Enhance VR platform in addition to standard care.
The intervention consists of daily 12-minute sessions for up to 7 days, targeting cognitive domains such as memory and attention.
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A bedside multi-domain rehabilitation program using a head-mounted display.
Participants perform 6 gamified tasks targeting both cognitive domains (information processing, attention, memory) and motor domains (motor control, dexterity, and bimanual coordination).
The protocol consists of daily 12-minute sessions for a maximum of 7 days.
Outros nomes:
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Comparador Ativo: Tablet-Based Rehabilitation (Tablet-Rehab)
Participants receive the same cognitive training exercises as the VR group via a 2D tablet interface in addition to standard care.
This arm serves to isolate the effect of digital content from immersion.
Sessions are 12 minutes daily for up to 7 days.
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A bedside rehabilitation program delivered via a handheld tablet.
Participants perform 2D versions of the same 6 tasks used in the VR arm, targeting the same cognitive and motor skills.
The protocol consists of daily 12-minute sessions for a maximum of 7 days.
Outros nomes:
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Sem intervenção: Standard of Care (SOC)
Participants receive the conventional ICU rehabilitation protocol provided by the clinical team, which includes standard physical and respiratory physiotherapy.
No structured digital cognitive training is provided to this group.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Prazo: Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
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The MoCA is a tool used to screen for cognitive impairment.
It assesses various cognitive domains including attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
The total score ranges from 0 to 30 points, with higher scores indicating better cognitive function.
For assessments conducted remotely (T3 and T4), a validated blinded/telephone version of the MoCA will be used.
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Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Medical Research Council Sum Score (MRC-SS)
Prazo: Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
|
The MRC-SS is used to assess muscle strength in six bilateral muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsiflexors).
Each muscle group is scored from 0 (total paralysis) to 5 (normal strength).
The total sum score ranges from 0 to 60, where higher scores indicate better physical strength and motor function.
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Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
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Impact of Event Scale-Revised (IES-R)
Prazo: Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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A self-report measure used to assess subjective distress caused by traumatic events (in this case, the ICU stay).
It contains 22 items covering three subscales: intrusion, avoidance, and hyperarousal.
Scores range from 0 to 88, with higher scores indicating a higher level of post-traumatic stress symptoms.
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Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Prazo: Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
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A standardized instrument for measuring generic health status.
It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 levels of severity.
It also includes a Visual Analogue Scale (VAS) where patients rate their health from 0 to 100.
Higher index scores and VAS scores indicate better quality of life.
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Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
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Patient Health Questionnaire-9 (PHQ-9)
Prazo: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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A 9-item multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
Each item is scored from 0 to 3. The total score ranges from 0 to 27, where 0-4 is minimal depression and 20-27 is severe depression.
Higher scores indicate greater severity of depressive symptoms.
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Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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Generalized Anxiety Disorder-7 (GAD-7)
Prazo: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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A 7-item self-report questionnaire for screening and severity measuring of generalized anxiety disorder.
Items are scored from 0 to 3. Total scores range from 0 to 21. Scores of 5, 10, and 15 represent cut-off points for mild, moderate, and severe anxiety, respectively.
Higher scores indicate greater anxiety.
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Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
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Simulator Sickness Questionnaire (SSQ)
Prazo: During the intervention period for the VR arm, after intervention (daily for up to 7 days).
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A standard tool used to measure "cybersickness" symptoms in VR.
It assesses 16 symptoms (like nausea, oculomotor strain, and disorientation) on a 4-point scale.
This will be used to monitor the safety and tolerability of the immersive VR intervention compared to the tablet.
Higher scores indicate greater discomfort.
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During the intervention period for the VR arm, after intervention (daily for up to 7 days).
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System Usability Scale (SUS)
Prazo: Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).
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A 10-item questionnaire used to evaluate the usability of the VR and Tablet systems.
It covers aspects like complexity and ease of use.
The final score is converted to a range of 0 to 100, where higher scores represent better user experience and higher system "acceptability."
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Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: João Ferreira-Coimbra, MD, Centro Hospitalar de São João, E.P.E.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Gerber SM, Jeitziner MM, Knobel SEJ, Mosimann UP, Muri RM, Jakob SM, Nef T. Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients. Front Med (Lausanne). 2019 Dec 10;6:287. doi: 10.3389/fmed.2019.00287. eCollection 2019.
- Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.
- Lai B, Powell M, Clement AG, Davis D, Swanson-Kimani E, Hayes L. Examining the Feasibility of Early Mobilization With Virtual Reality Gaming Using Head-Mounted Display and Adaptive Software With Adolescents in the Pediatric Intensive Care Unit: Case Report. JMIR Rehabil Assist Technol. 2021 May 27;8(2):e28210. doi: 10.2196/28210.
- Locke BW, Tsai TY, Reategui-Rivera CM, Gabriel AS, Smiley A, Finkelstein J. Immersive Virtual Reality Use in Medical Intensive Care: Mixed Methods Feasibility Study. JMIR Serious Games. 2024 Aug 9;12:e62842. doi: 10.2196/62842.
- Badke CM, Krogh-Jespersen S, Flynn RM, Shukla A, Essner BS, Malakooti MR. Virtual Reality in the Pediatric Intensive Care Unit: Patient Emotional and Physiologic Responses. Front Digit Health. 2022 Mar 28;4:867961. doi: 10.3389/fdgth.2022.867961. eCollection 2022.
- Vlake JH, van Bommel J, Hellemons ME, Wils EJ, Gommers D, van Genderen ME. Intensive Care Unit-Specific Virtual Reality for Psychological Recovery After ICU Treatment for COVID-19; A Brief Case Report. Front Med (Lausanne). 2021 Feb 5;7:629086. doi: 10.3389/fmed.2020.629086. eCollection 2020.
- Vlake JH, van Bommel J, Wils EJ, Bienvenu J, Hellemons ME, Korevaar TI, Schut AF, Labout JA, Schreuder LL, van Bavel MP, Gommers D, van Genderen ME. Intensive Care Unit-Specific Virtual Reality for Critically Ill Patients With COVID-19: Multicenter Randomized Controlled Trial. J Med Internet Res. 2022 Jan 31;24(1):e32368. doi: 10.2196/32368.
- Ong TL, Ruppert MM, Akbar M, Rashidi P, Ozrazgat-Baslanti T, Bihorac A, Suvajdzic M. Improving the Intensive Care Patient Experience With Virtual Reality-A Feasibility Study. Crit Care Explor. 2020 Jun 8;2(6):e0122. doi: 10.1097/CCE.0000000000000122. eCollection 2020 Jun.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de dezembro de 2025
Conclusão Primária (Estimado)
1 de maio de 2026
Conclusão do estudo (Estimado)
1 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 319-22 - VR4ICU
- 2022.13901.BDANA (Outro identificador: FCT)
- support UID/50014/2025 (Outro identificador: FCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .