Hospitalized PatientsNCT07089134
Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility
A study testing reabilitação fisioterapêutica tradicional and fisioterapia utilizando realidade virtual imersiva in people with Hospitalized Patients and ICU Hospitalization, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patients, ICU Hospitalization, Intensive Care Unit-acquired Weakness
- What is being tested?
- reabilitação fisioterapêutica tradicional and fisioterapia utilizando realidade virtual imersiva
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hemodynamic instability
- Signs of respiratory distress
- Contact isolation for infectious diseases
- Conditions that limit head and neck movement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sírio Libanês
São Paulo, São Paulo, 01308050
Wellington Yamaguti, PHD, 1133940200 ext. 4395, wellington.psyamaguti@hsl.org.br
Manoella C Andrade, Dra, 11950739911 ext. 4395, manoellacavalcantedeandrade@gmail.com
About this study
Official title: 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
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).
Read more
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.
- Being tested
- reabilitação fisioterapêutica tradicional, fisioterapia utilizando realidade virtual imersiva
- Keywords
- virtual reality, rehabilitation, intensive care, stress, satisfaction, patient experience
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reabilitação fisioterapêutica tradicionalProcedure or surgery
Active and passive exercises, and walking
fisioterapia utilizando realidade virtual imersivaProcedure or surgery
Use of immersive virtual reality headset for rehabilitation sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: fisioterapia utilizando realidade virtual imersiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 1 and day 7 or intensive care unit discharge
Secondary outcomes (10)
Classification of physical activity level
Physical activity assessment will be conducted using the International Physical Activity Questionnaire (IPAQ). The short version consists of seven open-ended questions, allowing estimation of the time spent per week in different dimensions of physical activity (walking, moderate and vigorous activities) and physical inactivity (sitting time). Based on IPAQ scoring guidelines, patients can be classified as: very active, active, irregularly active, or sedentary.
Measured: Baseline
Muscle Strength
Muscle strength will be assessed using the Medical Research Council (MRC) manual muscle test. This evaluation involves testing key upper limb muscles (shoulder abduction, elbow flexion, wrist extension) and lower limb muscles (hip flexion, knee extension, ankle dorsiflexion) against the examiner's resistance. Strength is rated on a scale from 0 (no muscle activation) to 5 (full range of motion against full examiner resistance). Classification is based on the degree of muscle contraction or range of motion for each muscle evaluated. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).
Measured: Baseline and after 7 days or intensive care unit discharge
Mobility Assessment
Patient mobility will be assessed using the ICU Mobility Scale. This scale ranges from 0 to 10 within a single domain, where a score of 0 indicates very low mobility (e.g., the patient performs only passive exercises in bed), and a score of 10 indicates high mobility (e.g., the patient walks independently without assistance).
Measured: Baseline and after 7 days or intensive care unit discharge
Functionality Classification
The International Classification of Functioning, Disability and Health (ICF) will be used to describe functionality and disability related to health conditions, considering body functions and structures, activity limitations, and participation restrictions in the patient's environment. A customized checklist adapted to the ICU context of Hospital Sírio-Libanês will be used in this study. Qualifiers specify the level of functioning, ranging from 0 (no impairment) to 4 (complete impairment). Codes 8 and 9 indicate lack of information or not applicable. In the body structure category, three qualifiers are used to describe the nature of the impairment. In the activity and participation category, two qualifiers are used: performance and capacity. For environmental factors, a positive score (1 to 4) indicates facilitators, while a negative score (-1 to -4) indicates barriers.
Measured: Baseline and after 7 days or intensive care unit discharge
Delirium Assessment
The diagnosis and monitoring of delirium during ICU stay will be performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). This is a quick and accurate tool for diagnosing delirium in critically ill patients, combining sedation and delirium monitoring.
Measured: Up to 7 days or intensive care unit discharge
Cognitive Function Assessment
Cognitive functions will be assessed using the Montreal Cognitive Assessment (MoCA), a brief screening tool that evaluates a wide range of cognitive domains, including executive functions, visuospatial abilities, naming, memory recall, digits, sentence repetition, abstract reasoning, and orientation. MoCA is considered effective for detecting mild cognitive impairment and dementia. The test is simple and quick to administer, taking approximately 20 minutes. The maximum score is 30 points, with a cutoff of 26; scores above 26 are considered normal.
Measured: Baseline and after 7 days or intensive care unit discharge
Assessment of Pain and Psychological Variables
To assess discomfort, the Numeric Rating Scale (NRS) will be used. This is a unidimensional tool that measures discomfort intensity and is suitable for conscious and communicative adult patients. Assessments will be performed before and after the rehabilitation protocol.
For pain assessment, patients will be asked to rate their pain on a scale from 0 to 10, where 0 represents no pain and 10 indicates the worst possible pain.
The same scale will be used to evaluate the perception of anxiety and stress, quantifying the intensity of these psychological variables.
Measured: Baseline and after 7 days or intensive care unit discharge
Rehabilitation Protocol Feasibility
The feasibility of the protocol will be measured through the adherence rate to immersive virtual reality therapy sessions. Adherence will be calculated as a percentage (%) using the formula: number of rehabilitation sessions completed / total number of eligible sessions × 100. In this study, a value above 70% will be considered indicative of good feasibility of the rehabilitation protocol.
Measured: After 7 days or intensive care unit discharge
Adverse Events: Fall risk
Fall risk will be assessed using the Johns Hopkins Fall Risk Assessment Tool. This scale stratifies and establishes personalized preventive measures for hospitalized patients. The total score categorizes patients as low risk (0-5 points), moderate risk (6-13 points), or high risk (14-35 points).
Measured: Up to 7 days or intensive care unit discharge
Adverse Events: Presence of symptoms
The presence of symptoms will be evaluated using the Simulator Sickness Questionnaire (SSQ), which assesses the presence and intensity of 16 symptoms, including general discomfort, fatigue, headache, eye strain, difficulty focusing, increased salivation, sweating, nausea, poor concentration, "heavy head," blurred vision, dizziness (eyes open/closed), vertigo, abdominal discomfort, and belching. Symptom intensity is rated as 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
Measured: Up to 7 days or intensive care unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Sep 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington Yamaguti, Hospital Sirio-Libanes
- Investigators
- Wellington Yamaguti, PHD, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089134
- Sponsor's protocol ID
- HSL SP 2025-64
- Status last verified
- Sep 2026
- First submitted
- 26 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07089134
- Acronym / sponsor ID
- HSL SP 2025-64
- Keywords
- virtual reality, rehabilitation, intensive care, stress, satisfaction, patient experience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| traditional physiotherapy rehabilitation | Active comparator | Procedure: reabilitação fisioterapêutica tradicionalThe 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. |
| physiotherapy using immersive virtual reality | Experimental | Procedure: fisioterapia utilizando realidade virtual imersivaThe immersive virtual reality physiotherapeutic rehabilitation protocol will employ 3D virtual reality headset that simulate human sensory input to create an immersive environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Hemodynamic instability
- Signs of respiratory distress
- Contact isolation for infectious diseases
- Conditions that limit head and neck movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reabilitação fisioterapêutica tradicionalActive and passive exercises, and walking | Procedure or surgery | traditional physiotherapy rehabilitation |
| fisioterapia utilizando realidade virtual imersivaUse of immersive virtual reality headset for rehabilitation sessions | Procedure or surgery | physiotherapy using immersive virtual reality |
Primary outcome
Patient satisfaction
Time frame: Day 1 and day 7 or intensive care unit discharge
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."
Patient experience: Perceived workload
Time frame: Day 1 and day 7 or intensive care unit discharge
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.
Patient experience: Perceived motivation
Time frame: Day 1 and day 7 or intensive care unit discharge
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).
Patient experience: Perceived presence
Time frame: Day 1 and day 7 or intensive care unit discharge
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.
10 secondary outcomes
Classification of physical activity level
Time frame: Baseline
Muscle Strength
Time frame: Baseline and after 7 days or intensive care unit discharge
Mobility Assessment
Time frame: Baseline and after 7 days or intensive care unit discharge
Functionality Classification
Time frame: Baseline and after 7 days or intensive care unit discharge
Delirium Assessment
Time frame: Up to 7 days or intensive care unit discharge
Cognitive Function Assessment
Time frame: Baseline and after 7 days or intensive care unit discharge
Assessment of Pain and Psychological Variables
Time frame: Baseline and after 7 days or intensive care unit discharge
Rehabilitation Protocol Feasibility
Time frame: After 7 days or intensive care unit discharge
Adverse Events: Fall risk
Time frame: Up to 7 days or intensive care unit discharge
Adverse Events: Presence of symptoms
Time frame: Up to 7 days or intensive care unit discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wellington Yamaguti, PHD principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reabilitação fisioterapêutica tradicional and fisioterapia utilizando realidade virtual imersiva in people with Hospitalized Patients and ICU Hospitalization, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wellington Yamaguti, PHD (1133940200 ext. 4395, wellington.psyamaguti@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Day 1 and day 7 or intensive care unit discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.