Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07089134 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Jun 30, 2026 → Aug 30, 2028
See other at-risk trials from Hospital Sirio-Libanes

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 30, 2026 to Aug 30, 2028 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Dec 15, 2025 to Sep 1, 2026
    • Study completion pushed from Aug 31, 2026 to Oct 30, 2028
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised
  2. Notable Start date: Jul 2025 to Dec 15, 2025
    • Primary completion date: Jun 2026 to Jun 30, 2026
    • Study completion date: Aug 2026 to Aug 31, 2026
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07089134
Lead Sponsor Hospital Sirio-Libanes
Conditions
(from sponsor)
Hospitalized Patients, ICU Hospitalization, Intensive Care Unit-acquired Weakness
Related terms Personal Satisfaction
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov