Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility
NCT ID: NCT07089134
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-12-15
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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traditional physiotherapy rehabilitation
The traditional physiotherapeutic rehabilitation protocol will be guided by the characteristics of the early rehabilitation protocol in the ICU, structured by the rehabilitation service of Hospital Sírio-Libanês. This protocol provides recommendations for effective and applicable exercises based to the clinical reality, serving as a guiding resource in the care of critically ill patients.
reabilitação fisioterapêutica tradicional
Active and passive exercises, and walking
physiotherapy using immersive virtual reality
The immersive virtual reality physiotherapeutic rehabilitation protocol will employ 3D virtual reality headset that simulate human sensory input to create an immersive environment.
fisioterapia utilizando realidade virtual imersiva
Use of immersive virtual reality headset for rehabilitation sessions
Interventions
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reabilitação fisioterapêutica tradicional
Active and passive exercises, and walking
fisioterapia utilizando realidade virtual imersiva
Use of immersive virtual reality headset for rehabilitation sessions
Eligibility Criteria
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Inclusion Criteria
* 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
* Signs of respiratory distress
* Contact isolation for infectious diseases
* Conditions that limit head and neck movement
18 Years
ALL
No
Sponsors
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Hospital Sirio-Libanes
OTHER
Responsible Party
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Wellington Yamaguti
Principal Investigator
Principal Investigators
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Wellington Yamaguti, PHD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sírio-Libanês
Locations
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Hospital Sírio Libanês
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSL SP 2025-64
Identifier Type: -
Identifier Source: org_study_id
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