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Post-Intensive Care Syndrome (PICS)VR4ICUNCT07585500

Virtual Reality for Recovery After Intensive Care (PICS)

A study testing Immersive VR Multi-Domain Rehabilitation and Tablet-Based Multi-Domain Training in people with Post-Intensive Care Syndrome (PICS) and Critical Illness Recovery, run by University of Minho at 1 site in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immersive VR Multi-Domain Rehabilitation and Tablet-Based Multi-Domain Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 sitePortugal
Study dates
6 Dec 2025to Jun 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 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nuno F. Rodrigues contact

929145931 ext. +351

nunofeixa@gmail.com

Inês Oliveira contact

965796047 ext. +351

ines.t.oliveira@gmail.com

Portugal1 site, 1 recruiting

  • Centro Hospitalar Universitário São João

    Porto, Porto District, 4200-319

    João Ferreira-Coimbra, MD, 912712480 ext. +351, joaoferreiracoimbra@gmail.com

    João Ferreira-Coimbra, MD

    Recruiting

Other trials in Portugal

About this study

Official title: 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:

Read more
  • 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.
Read the detailed description

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:

  1. 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.
  2. 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.
  3. 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."

Being tested
Immersive VR Multi-Domain Rehabilitation, Tablet-Based Multi-Domain Training
Keywords
Post-Intensive Care Syndrome (PICS), Cognitive Impairment, Critical Illness, Virtual Reality (VR), Digital Health, Rehabilitation, Intensive Care Unit (ICU), Critical Care, ICU Survivors, Pilot Study, Randomized Controlled Trial
Medical subject headings
postintensive care syndrome, Cognitive Dysfunction, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive VR Multi-Domain RehabilitationDevice

    Also called Meta Quest Pro, Enhance VR (Virtuleap), VR-Rehab

    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.

  • Tablet-Based Multi-Domain TrainingDevice

    Also called Samsung Galaxy S5e, 2D Digital Rehabilitation, Tablet-Rehab

    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.

Study groups in NCT07585500
Study groupRoleWhat they receive
VR-Based Rehabilitation (VR-Rehab)ExperimentalParticipants 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.
Receives: Device: Immersive VR Multi-Domain Rehabilitation
Tablet-Based Rehabilitation (Tablet-Rehab)Active comparatorParticipants 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.
Receives: Device: Tablet-Based Multi-Domain Training
Standard of Care (SOC)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MoCA)

    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.

    Measured: 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).

Secondary outcomes (7)

  1. Medical Research Council Sum Score (MRC-SS)

    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.

    Measured: 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).

  2. Impact of Event Scale-Revised (IES-R)

    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.

    Measured: 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).

  3. EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    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.

    Measured: 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).

  4. Patient Health Questionnaire-9 (PHQ-9)

    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.

    Measured: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).

  5. Generalized Anxiety Disorder-7 (GAD-7)

    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.

    Measured: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).

  6. Simulator Sickness Questionnaire (SSQ)

    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.

    Measured: During the intervention period for the VR arm, after intervention (daily for up to 7 days).

  7. System Usability Scale (SUS)

    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."

    Measured: Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start6 Dec 2025
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Model description
This is a 3-arm, parallel-group, pilot randomized controlled trial comparing two active digital intervention groups (Immersive VR and 2D Tablet) against a Standard of Care control group.
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585500
Sponsor's protocol ID
319-22 - VR4ICU
Other IDs
2022.13901.BDANA, support UID/50014/2025
Acronym
VR4ICU
Status last verified
May 2026
First submitted
29 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34042602

  • 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.

    PubMed 39046869

  • 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.

    PubMed 35419557

  • 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.

    PubMed 34783683

  • 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.

    PubMed 33614677

  • 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.

    PubMed 34978530

  • 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.

    PubMed 31921867

  • 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.

    PubMed 32695991

Questions about this trial

What is this clinical trial studying?

A study testing Immersive VR Multi-Domain Rehabilitation and Tablet-Based Multi-Domain Training in people with Post-Intensive Care Syndrome (PICS) and Critical Illness Recovery, run by University of Minho at 1 site in Portugal.

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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. 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?

Contact Nuno F. Rodrigues (929145931 ext. +351, nunofeixa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: 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).). 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 NCT07585500, which also lists 8 linked publications.

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 13 May 2026.

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