NCT07089134

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospitalized Patients
• ICU Hospitalization
• Intensive Care Unit-acquired Weakness

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2025-07-28
• Last updated: 2025-09-12

Locations

1 site across 1 country: Brazil