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Clinical Trials in Brazil / NCT07089134
Recruiting Not applicable

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

NCT07089134 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-15

Condition(s) studied

Hospitalized PatientsICU HospitalizationIntensive Care Unit-acquired Weakness

Investigational drug(s) / intervention(s)

reabilitação fisioterapêutica tradicionalfisioterapia utilizando realidade virtual imersiva

reabilitação fisioterapêutica tradicional: Active and passive exercises, and walking

fisioterapia utilizando realidade virtual imersiva: Use of immersive virtual reality headset for rehabilitation sessions

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Sírio Libanês São Paulo São Paulo Recruiting

More Hospital Sirio-Libanes trials in Brazil

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07089134 on ClinicalTrials.gov ↗ ← All trials in Brazil