Not Yet RecruitingNot Applicable

Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility

Brazil90 participantsStarted 2025-12-15

Plain-language summary

Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes. Objective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU). Methods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22. Expected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged ≥18 years * Glasgow Coma Scale (GCS) score ≥14 * Richmond Agitation-Sedation Scale (RASS) score between -1 and +1 * Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) * Estimated ICU stay of ≥72 hours * Able to communicate in Portuguese * Understand and follow verbal instructions * Have no psychotic disorders, visual impairment or hearing loss. Exclusion Criteria: * Hemodynamic instability * Signs of respiratory distress * Contact isolation for infectious diseases * Conditions that limit head and neck movement

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is using virtual reality in the ICU to improve patient experience and prevent muscle weakness — is this something my care team is even considering for my situation, and would I be a candidate to discuss once it starts recruiting?
2Since the trial is 'not yet recruiting,' how far away is it from opening, and what would the enrollment process look like if I wanted to revisit this option later during my ICU stay or recovery?
3The study is measuring things like perceived motivation and sense of 'presence' in virtual reality — what does that mean practically for a patient in intensive care, and would using VR be physically demanding or stressful given my current condition?
4ICU-acquired weakness is one of the conditions this trial focuses on — how significant is that risk for me specifically, and are there already standard rehabilitation approaches my team is using that might address the same concern?
5Since this trial doesn't have a traditional phase number and seems focused on feasibility and patient experience rather than a treatment drug, does that mean the main goal is to see if VR is tolerable and acceptable, rather than to prove it improves medical outcomes — and how should that affect how I think about it compared to my other care options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived workload

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived motivation

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived presence

Timeframe: Day 1 and day 7 or intensive care unit discharge

Trial details

NCT IDNCT07089134

SponsorHospital Sirio-Libanes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Wellington Yamaguti, PHD

1133940200 wellington.psyamaguti@hsl.org.br

View on ClinicalTrials.gov More Hospitalized Patients trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient satisfaction

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived workload

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived motivation

Timeframe: Day 1 and day 7 or intensive care unit discharge

Patient experience: Perceived presence

Timeframe: Day 1 and day 7 or intensive care unit discharge