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

Hospital Sirio-Libanes

Status: Not yet enrolling

Conditions: ICU Hospitalization; Hospitalized Patients; Intensive Care Unit-acquired Weakness

Treatments: Procedure: fisioterapia utilizando realidade virtual imersiva; Procedure: reabilitação fisioterapêutica tradicional

Study type: Interventional

Funder types: Other

Identifiers

NCT07089134

HSL SP 2025-64

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

traditional physiotherapy rehabilitation

Active Comparator group

Description:

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.

Treatment:

Procedure: reabilitação fisioterapêutica tradicional

physiotherapy using immersive virtual reality

Experimental group

Description:

The immersive virtual reality physiotherapeutic rehabilitation protocol will employ 3D virtual reality headset that simulate human sensory input to create an immersive environment.

Treatment:

Procedure: fisioterapia utilizando realidade virtual imersiva