Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: reabilitação fisioterapêutica tradicional, fisioterapia utilizando realidade virtual imersiva.
- Who it may be relevant to
- Registry conditions: Hospitalized Patients, ICU Hospitalization, Intensive Care Unit-acquired Weakness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Immersive Virtual Reality Rehabilitation on Patient Satisfaction and Experience, Functional and Clinical Outcomes, and Its Feasibility in Intensive Care Unit Treatment: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure reabilitação fisioterapêutica tradicional
Active and passive exercises, and walking - Procedure fisioterapia utilizando realidade virtual imersiva
Use of immersive virtual reality headset for rehabilitation sessions
Primary outcome measures
- Patient satisfaction [Time frame: Day 1 and day 7 or intensive care unit discharge]
- Patient experience: Perceived workload [Time frame: Day 1 and day 7 or intensive care unit discharge]
- Patient experience: Perceived motivation [Time frame: Day 1 and day 7 or intensive care unit discharge]
- Patient experience: Perceived presence [Time frame: Day 1 and day 7 or intensive care unit discharge]
Secondary outcome measures (10)
- Classification of physical activity level [Time frame: Baseline]
- Muscle Strength [Time frame: Baseline and after 7 days or intensive care unit discharge]
- Mobility Assessment [Time frame: Baseline and after 7 days or intensive care unit discharge]
- Functionality Classification [Time frame: Baseline and after 7 days or intensive care unit discharge]
- Delirium Assessment [Time frame: Up to 7 days or intensive care unit discharge]
- Cognitive Function Assessment [Time frame: Baseline and after 7 days or intensive care unit discharge]
- Assessment of Pain and Psychological Variables [Time frame: Baseline and after 7 days or intensive care unit discharge]
- Rehabilitation Protocol Feasibility [Time frame: After 7 days or intensive care unit discharge]
- Adverse Events: Fall risk [Time frame: Up to 7 days or intensive care unit discharge]
- Adverse Events: Presence of symptoms [Time frame: Up to 7 days or intensive care unit discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital Sírio Libanês — São Paulo
Identifiers
NCT: NCT07089134 · HSL SP 2025-64