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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Hospital Sirio-Libanes • ClinicalTrials.gov ID: NCT07089134

Registry updated: 2026-09-15
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Description

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

  • reabilitação fisioterapêutica tradicional (Procedure)
    Active and passive exercises, and walking
  • fisioterapia utilizando realidade virtual imersiva (Procedure)
    Use of immersive virtual reality headset for rehabilitation sessions

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

Conditions

Hospitalized Patients ICU Hospitalization Intensive Care Unit-acquired Weakness

Locations

  • Hospital Sírio Libanês — São Paulo, São Paulo, Brazil
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record