DeliriumNCT06153472
Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units
A study testing VR-based intervention in people with Delirium and Intensive Care Unit, run by Chinese University of Hong Kong.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main questions it aims to answer are: Is the VR-based sensory stimulation system more effective in preventing ICU delirium compared to usual care? Does VR sensory… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium, Intensive Care Unit, Randomised Controlled Trial
- What is being tested?
- VR-based intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ICU patients admitted to the study setting will be recruited if they are have: (1) ≥ 18 years, (2) the first time admitted to ICU and (3) a Richmond Agitation-Sedation Scale (RASS) score ≥-3
Who cannot join
- Patients will be excluded if they have: (1) been diagnosed with dementia, delirium or acute psychiatric illness at admission, (2) been diagnosed with end-stage cancer, (3) severe hearing impairment and cannot be corrected by hearing aids and (4) been admitted to ICU with radioactive material.
About this study
The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main questions it aims to answer are:
Is the VR-based sensory stimulation system more effective in preventing ICU delirium compared to usual care? Does VR sensory stimulation improve patient psychological well-being and clinical outcomes in the ICU?
Read more
Participants will:
Experimental Group:
Engage in VR-based sensory stimulation sessions involving visual or/and auditory stimulation.
Control Group:
Receive usual care without additional VR-based interventions.
Comparison:
Researchers will compare the outcomes between the experimental group (receiving VR-based sensory stimulation) and the control group (receiving usual care) to determine the effects of VR sensory stimulation on ICU delirium prevention, as well as its impact on patient psychological well-being and clinical outcomes.
- Conditions
- Delirium, Intensive Care Unit, Randomised Controlled Trial
- Being tested
- VR-based intervention
- Keywords
- delirium, intensive care unit, randomised controlled trial, sensory stimulation, virtual reality
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based interventionDevice
The Virtual Reality-based sensory stimulation intervention will last for up to fourteen days, with all interventions administered by a research team. The primary outcomes will include delirium incidence, duration, and severity. The secondary outcomes will encompass patients' psychological well-being (post-traumatic stress disorder, sleep quality, and ICU memory), patients' clinical outcomes, and other outcomes (quality of life, independence, and cognitive function).
| Study group | Role | What they receive |
|---|---|---|
| VR-based sensory stimulation | Experimental | Participants in the experimental group will receive VR-based sensory stimulation. Receives: Device: VR-based intervention |
| Usual care | No intervention | Participants in the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence, duration and severity
Delirium incidence means the number of patients who are delirious and delirium duration means the number of days that a patient is delirious.
Measured: From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.
Secondary outcomes (7)
Sleep quality
The Richards-Campbell Sleep Questionnaire (RCSQ) is employed to assess the sleep quality of ICU patients.
Measured: From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.
Post Traumatic Stress Disorder
The 17-item PTSD Checklist (PCL) correspond to the DSM-III-R symptoms of PTSD and serves as a self-report scale for assessing PTSD
Measured: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
ICU memory
The ICU-Memory Tool (ICU-M) will be used to measure ICU patients' ICU experience
Measured: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Patients' clinical outcomes
Medical outcomes will be extracted by the outcome assessor from the electronic health care system upon participants' discharge.
Measured: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Participants' quality of life
The EuroQol- 5 Dimension (EQ-5D) will be used to assess the participants' quality of life.
Measured: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
Independence function
Motor-FIM (Functional Independence Measure) will be used to measure the independence function.
Measured: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
cognitive function
Cognitive-FIM (Functional Independence Measure) will be used to measure the cognitive function.
Measured: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital
- Responsible party
- Principal investigator, Liang Surui, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153472
- Sponsor's protocol ID
- 2023K089
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang S, Liu Y, Wen T, Luo D, He M, Tian J. Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol. BMJ Open. 2025 Jan 15;15(1):e083966. doi: 10.1136/bmjopen-2024-083966.
PubMed 39819916
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units
- ClinicalTrials.gov ID
- NCT06153472
- Acronym / sponsor ID
- 2023K089
- Conditions
- Delirium, Intensive Care Unit, Randomised Controlled Trial
- Keywords
- delirium, intensive care unit, randomised controlled trial, sensory stimulation, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2023 (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.
The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main questions it aims to answer are:
Is the VR-based sensory stimulation system more effective in preventing ICU delirium compared to usual care? Does VR sensory stimulation improve patient psychological well-being and clinical outcomes in the ICU?
Participants will:
Experimental Group:
Engage in VR-based sensory stimulation sessions involving visual or/and auditory stimulation.
Control Group:
Receive usual care without additional VR-based interventions.
Comparison:
Researchers will compare the outcomes between the experimental group (receiving VR-based sensory stimulation) and the control group (receiving usual care) to determine the effects of VR sensory stimulation on ICU delirium prevention, as well as its impact on patient psychological well-being and clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-based sensory stimulation | Experimental | Device: VR-based interventionParticipants in the experimental group will receive VR-based sensory stimulation. |
| Usual care | No intervention | –Participants in the control group will receive usual care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All ICU patients admitted to the study setting will be recruited if they are have: (1) ≥ 18 years, (2) the first time admitted to ICU and (3) a Richmond Agitation-Sedation Scale (RASS) score ≥-3
Key exclusion criteria (1 listed)
- Patients will be excluded if they have: (1) been diagnosed with dementia, delirium or acute psychiatric illness at admission, (2) been diagnosed with end-stage cancer, (3) severe hearing impairment and cannot be corrected by hearing aids and (4) been admitted to ICU with radioactive material.
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 |
|---|---|---|
| VR-based interventionThe Virtual Reality-based sensory stimulation intervention will last for up to fourteen days, with all interventions administered by a research team. The primary outcomes will include delirium incidence, duration, and severity. The secondary outcomes will encompass patients' psychological well-being (post-traumatic stress disorder, sleep quality, and ICU memory), patients' clinical outcomes, and other outcomes (quality of life, independence, and cognitive function). | Device | VR-based sensory stimulation |
Primary outcome
Delirium incidence, duration and severity
Time frame: From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.
Delirium incidence means the number of patients who are delirious and delirium duration means the number of days that a patient is delirious.
7 secondary outcomes
Sleep quality
Time frame: From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.
Post Traumatic Stress Disorder
Time frame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
ICU memory
Time frame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Patients' clinical outcomes
Time frame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Participants' quality of life
Time frame: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
Independence function
Time frame: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
cognitive function
Time frame: Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month
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 1 Dec 2023.
- Derived from this study: PubMed 39819916Liang S, Liu Y, Wen T, Luo D, He M, Tian J. Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol. BMJ Open. 2025 Jan 15;15(1):e083966. doi: 10.1136/bmjopen-2024-083966.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based intervention in people with Delirium and Intensive Care Unit, run by Chinese University of Hong Kong.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence, duration and severity (time frame: From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153472, which also lists 1 linked publication.
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 1 Dec 2023.