Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07585500

Virtual Reality Intervention for Post-Intensive Care Syndrome (PICS): A Pilot Randomized Controlled Trial Evaluating Cognitive, Physical, and Psychological Outcomes

Led by University of Minho · Updated on 2026-05-13

51

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Minho

Lead Sponsor

U

Universidade do Porto

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial investigates whether virtual reality (VR) helps improve thinking and memory skills in adults who have stayed in the intensive care unit (ICU). It focuses on patients who required a breathing machine or had a long ICU stay and are at risk of memory or brain fog problems. The study compares the effects of immersive VR, tablet-based brain games, and standard care on cognitive recovery after critical illness. Participants are randomly assigned to one of three groups: VR-based rehabilitation using a headset to play six brain-training games, tablet-based rehabilitation with the same games on a 2D device, or standard ICU care without digital cognitive training. Each digital therapy involves daily 12-minute sessions for up to seven days or until ICU discharge. The VR group uses a Meta Quest Pro device for immersive cognitive and motor exercises, while the tablet group uses a handheld device for the same tasks. During the study, participants complete memory and thinking tests at the start and about two weeks later. They also answer follow-up questions about their cognitive abilities for up to six months after hospital discharge. Safety is monitored continuously during therapy sessions, and researchers track outcomes like the Montreal Cognitive Assessment. Additional evaluations include muscle strength, post-trauma stress, quality of life, mood, anxiety, and any VR-related discomfort. The study lasts several months, with multiple follow-up visits to assess recovery.

CONDITIONS

Brief Title

Virtual Reality for Recovery After Intensive Care (PICS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients, 18 years or older
  • Patients currently in the Intensive Care Unit
  • Ventilated patients must be in the post-extubation period
  • Projected remaining hospital stay of at least 4 days as assessed by clinical team
  • Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
  • Ability to move both arms, even if with difficulties, to interact with the software
  • Ability to maintain a stable sitting position (30° to 60° angle)
  • Ability to communicate by speech, gesturing, or writing
  • Ability to communicate and understand Portuguese
  • Informed consent provided by patient or legal representative
Not Eligible

You will not qualify if you...

  • Severe cognitive or neurodegenerative diseases such as mental illness requiring institutionalization or severe brain injuries
  • Use of neuromuscular blocking agents
  • Positive CAM-ICU result during initial screening
  • Active psychotic disorders or suicidal ideation
  • Documented epilepsy or history of seizures
  • "Do Not Resuscitate" order, life support focused on comfort, or expected survival less than 24 hours
  • Active substance intoxication or withdrawal preventing safe participation
  • Severe immobility or motor limitations in upper limbs or neck
  • Open wounds on head or face that interfere with VR device use
  • Uncorrected blindness or deafness preventing safe use of VR or tablet devices
  • Participation in another rehabilitation study with interventions
  • Scheduled surgery with ICU stay expected under 24 hours
  • Need for respiratory support at enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 7 days or until ICU discharge

Participants receive bedside rehabilitation sessions using either a virtual reality headset or a tablet to engage in cognitive and motor training. Sessions last approximately 12 minutes daily for up to 7 consecutive days or until ICU discharge. Participants in the standard care group receive conventional ICU rehabilitation without structured digital training.

Daily sessions for up to 7 days

Follow-up

Duration - Up to 6 months post-discharge

Participants are monitored after the intervention with scheduled assessments to evaluate cognitive, physical, and psychological recovery. These follow-ups occur up to 6 months post-discharge.

3 visits (approximately 15-22 days, 30-45 days, and 3 to 6 months post-discharge)

Trial Site Locations

Total: 1 location

1

Centro Hospitalar Universitário São João

Porto, Porto District, Portugal, 4200-319

Actively Recruiting

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Research Team

N

Nuno F. Rodrigues

I

Inês Oliveira

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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.

Byron Lai, Maegen Powell, Anne Grace Clement...

https://pubmed.ncbi.nlm.nih.gov/34042602

Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients.

Floriane Rousseaux, Nadia Dardenne, Paul B Massion...

https://pubmed.ncbi.nlm.nih.gov/34783683

Intensive Care Unit-Specific Virtual Reality for Psychological Recovery After ICU Treatment for COVID-19; A Brief Case Report.

Johan H Vlake, Jasper van Bommel, Merel E Hellemons...

https://pubmed.ncbi.nlm.nih.gov/33614677

Intensive Care Unit-Specific Virtual Reality for Critically Ill Patients With COVID-19: Multicenter Randomized Controlled Trial.

Johan H Vlake, Jasper van Bommel, Evert-Jan Wils...

https://pubmed.ncbi.nlm.nih.gov/34978530

Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients.

Stephan M Gerber, Marie-Madlen Jeitziner, Samuel E J Knobel...

https://pubmed.ncbi.nlm.nih.gov/31921867