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

NCT07089134 | Not Yet Recruiting

• 1 other identifier: HSL SP 2025-64
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

virtual reality; rehabilitation; intensive care; stress; satisfaction; patient experience

Outcome Measures

Primary Outcomes (4)

• Patient satisfaction

  To assess patient satisfaction, the investigators will use the Net Promoter Score (NPS) method, it is a methodology that indicates the likelihood of a consumer recommending products or services to others. The results are interpreted using the following parameters: 75-100% is considered "excellent," 50-74% is classified as "very good" and below 49% as "poor."

  Day 1 and day 7 or intensive care unit discharge

• Patient experience: Perceived workload

  To evaluate patient experience, the Raw Task Load Index (RTLX) will be used to assess perceived workload during or immediately after rehabilitation sessions. It is a multidimensional scale scored from 0 to 100, with higher scores indicating greater cognitive load.

  Day 1 and day 7 or intensive care unit discharge

• Patient experience: Perceived motivation

  Perceived motivation will be assessed using the Intrinsic Motivation Inventory (IMI), a 7-point Likert scale evaluating the individual's subjective experience during an activity (1 = strongly disagree; 7 = strongly agree).

  Day 1 and day 7 or intensive care unit discharge

• Patient experience: Perceived presence

  Patients in the immersive virtual reality group will also complete the Presence Questionnaire (PQ), a self-report tool that measures perceived presence in the VR environment across four domains: Engagement, Immersion/Adaptation, Sensory Fidelity, and Interface Quality. The PQ uses a 5-point Likert scale, with higher scores reflecting a stronger sense of presence.

  Day 1 and day 7 or intensive care unit discharge

Secondary Outcomes (10)

• Classification of physical activity level

  Baseline

• Muscle Strength

  Baseline and after 7 days or intensive care unit discharge

• Mobility Assessment

  Baseline and after 7 days or intensive care unit discharge

• Functionality Classification

  Baseline and after 7 days or intensive care unit discharge

• Delirium Assessment

  Up to 7 days or intensive care unit discharge

Study Arms (2)

traditional physiotherapy rehabilitation

ACTIVE COMPARATOR

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.

Procedure: reabilitação fisioterapêutica tradicional

physiotherapy using immersive virtual reality

EXPERIMENTAL

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

Procedure: fisioterapia utilizando realidade virtual imersiva

Interventions

reabilitação fisioterapêutica tradicional PROCEDURE

Active and passive exercises, and walking

traditional physiotherapy rehabilitation

fisioterapia utilizando realidade virtual imersiva PROCEDURE

Use of immersive virtual reality headset for rehabilitation sessions

physiotherapy using immersive virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamic instability
• Signs of respiratory distress
• Contact isolation for infectious diseases
• Conditions that limit head and neck movement

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308050, Brazil

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Wellington Yamaguti, PHD

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wellington Yamaguti, PHD

CONTACT

1133940200; wellington.psyamaguti@hsl.org.br

Manoella C Andrade, Dra

CONTACT

11950739911; manoellacavalcantedeandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Considering that patients enrolled in the study must complete a total of 6 to 14 rehabilitation protocol sessions, and in order to ensure the accuracy of the outcomes analyzed, participants who are absent for more than two consecutive rehabilitation sessions or who do not complete at least 70% of the total number of sessions will be excluded from the final analysis of the study.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 28, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)