Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000967482p
Ethics application status
Not yet submitted
Date submitted
3/08/2025
Date registered
3/09/2025
Date last updated
3/09/2025
Date data sharing statement initially provided
3/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Impact of Virtual Reality on Stress and Anxiety Levels in Patients Admitted to Intensive Care Units
Scientific title
Investigating the Effect of Virtual Reality for Calming Anxiety and Reducing Emotional Distress in Patients Admitted to ICU: A Randomised Control Trial (VR CARE-ICU)
Secondary ID [1] 315055 0
none
Universal Trial Number (UTN)
Trial acronym
VR CARE-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical care 338423 0
Condition category
Condition code
Public Health 334725 334725 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure: Adult patients (aged 18–80 years) admitted to the ICU for greater than or equal to 48 hours and requiring critical care support (e.g., vasopressors, non-invasive ventilation, high-flow nasal oxygen, renal replacement therapy, or post-extubation).

Intervention: Participants in the experimental group will engage with a gamified and interactive Virtual Reality (VR) program delivered using a Pico 4 Enterprise headset with disposable infection-control covers and noise-isolating earphones. A connected laptop will record session data and vital signs.

Procedures and activities: Each session will include (1) passive visual scenes with audio, (2) narrative-guided relaxation content, and (3) light interactive modules (e.g., arranging objects, simple puzzle tasks). The content is designed to accommodate ICU patients’ limited mobility.

Frequency and duration: Up to three VR sessions per day for four ICU days, depending on clinical status and tolerance. Each session will last approximately 15 minutes.

Training and instructions: A short (5-minute) verbal explanation of the headset and activities will be provided by a trained research assistant or ICU nurse immediately prior to the first session.

Supervision: All sessions will be supervised by ICU nurses and/or research assistants, who will assist with headset fitting, remain present to monitor patient safety and comfort, and remove the headset immediately if the participant wishes to discontinue or experiences discomfort.

Choice of VR content: Participants will be offered three sets of modules: a passive experience with only the environment, ambient music, and sounds; a narrative-guided experience; an interactive experience where participants can engage with objects, activate scenes, complete puzzle challenges, and move through the story at their own pace, becoming active participants in the narrative). Participants will get a chance to choose which module suits them best, depending on their mental state, energy level, or mood that day (nature exploration, relaxation, light games). If unable to choose, a default calming narrative module will be provided.

Monitoring and adherence: Session duration, frequency, and adherence will be recorded automatically by the headset and logged by research staff. Vital signs and eye-tracking will be monitored in real time to assess alertness and detect any adverse reactions.
Intervention code [1] 331662 0
Treatment: Devices
Comparator / control treatment
Control group: Control patients will wear an identical headset delivering ambient audio only, matched in frequency and duration, to control for expectancy and novelty effects.
Participants in the sham group will wear the same Pico 4 Enterprise headset with disposable covers and noise-isolating earphones, under identical conditions to the intervention group. However, instead of immersive VR content, the headset will deliver ambient audio only (e.g., neutral background sounds such as soft white noise or low-level environmental audio). No visual display or interactive components will be presented.

The sham intervention will be matched in both frequency and duration to the experimental group (up to three 15-minute sessions per day for four ICU days). Headset fitting, verbal instructions, and supervision procedures will be the same as for the intervention group to ensure consistency.
Control group
Active

Outcomes
Primary outcome [1] 342377 0
Feasibility of implementing VR in routine ICU care
Timepoint [1] 342377 0
Cumulative data will be assessed at the conclusion of recruitment.
Secondary outcome [1] 450591 0
Change in self-reported anxiety.
Timepoint [1] 450591 0
Baseline (prior to the first VR/sham session) and then immediately after the last scheduled VR/sham session at the end of each ICU study day, for up to 4 days (total of 4 post-session assessments).
Secondary outcome [2] 450592 0
Stress levels
Timepoint [2] 450592 0
Baseline (prior to the first VR/sham session) and then immediately after the last scheduled VR/sham session at the end of each ICU study day, for up to 4 consecutive days (total of 4 post-session assessments).
Secondary outcome [3] 450593 0
Immersion ratings, usability ratings, and acceptability ratings This will be assessed as a composite outcome comprising immersion ratings, usability ratings, and acceptability ratings. Patient-reported outcomes collected using validated questionnaires.
Timepoint [3] 450593 0
At the end of the last VR session prior to ICU discharge.
Secondary outcome [4] 450594 0
VR-related complications (headache, nausea, pressure injuries)
Timepoint [4] 450594 0
Immediately after each VR/sham session (up to 3 per day for 4 ICU days).
Secondary outcome [5] 450595 0
Patient satisfaction with the VR/sham intervention
Timepoint [5] 450595 0
Patient: End of last VR session prior to ICU discharge.
Secondary outcome [6] 450596 0
Use of pharmacological agents for sedation/anxiety
Timepoint [6] 450596 0
Daily during ICU admission and as required, up to hospital discharge, as determined by clinicians.
Secondary outcome [7] 450597 0
Composite outcome comprising both ICU length of stay and overall hospital length of stay.
Timepoint [7] 450597 0
Assessed once at ICU discharge (for ICU length of stay) and once at hospital discharge (for total hospital length of stay).
Secondary outcome [8] 450598 0
Delirium incidence
Timepoint [8] 450598 0
Daily during ICU admission and as required, up to hospital discharge, as determined by clinicians.
Secondary outcome [9] 451242 0
Staff satisfaction with its feasibility and integration into ICU workflows.
Timepoint [9] 451242 0
After study completion at each site.

Eligibility
Key inclusion criteria
Adults aged 18–80 years.
Admitted to ICU and expected to remain greater than or equal to 48 hours.
Richmond Agitation-Sedation Scale (RASS) of -1 to +1 at enrolment.
Fluent in English
Able to provide informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological or psychiatric illness.
Claustrophobia, agoraphobia.
Hearing or vision impairment.
Confusion or GCS <10.
Non-English speaking.
Anticipated ICU stay <48 hours.
Refusal to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated permuted block randomisation of varying lengths, as recommended by CONSORT
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis plan: Sample size: Based on an expected medium effect size (Cohen’s d=0.5), SD=4.0, a=0.05, and 80% power, 64 patients per group are needed to detect a 1.5-point difference in HADS-A scores.10 Allowing for 20% attrition increases this to 80 per group (160 total). Adjusting for clustering across six sites (ICC=0.02; average cluster size=27), the design effect (1.52) yields a final target of 244 patients (122/group). However, as an exploratory pilot, we aim to recruit 90-96 patients (45-48/group), with ~2.7 patients/site/month using consecutive sampling.
Statistical analysis: An intention-to-treat analysis will be conducted. The feasibility will be estimated by variability, effect size, recruitment, and retention rates. Linear mixed-effects models will evaluate changes in anxiety, with fixed effects for group, time, and interaction, and random intercepts for site. Secondary outcomes will be analysed similarly. Subgroup analyses (age, sex) and exploratory models (e.g. sedation, illness severity) will be included. Emphasis will be on effect sizes and 95%CIs rather than hypothesis testing, in line with CONSORT guidelines for pilot trials. R will be used for analysis, and missing data will be addressed using multiple imputation where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28282 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [2] 28283 0
Casey Hospital - Berwick
Recruitment hospital [3] 28284 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 28285 0
Victorian Heart Hospital - Clayton
Recruitment hospital [5] 28286 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 28287 0
Werribee Mercy Hospital - Werribee
Recruitment postcode(s) [1] 44497 0
3175 - Dandenong
Recruitment postcode(s) [2] 44498 0
3806 - Berwick
Recruitment postcode(s) [3] 44499 0
3168 - Clayton
Recruitment postcode(s) [4] 44500 0
3084 - Heidelberg
Recruitment postcode(s) [5] 44501 0
3030 - Werribee

Funding & Sponsors
Funding source category [1] 319622 0
Self funded/Unfunded
Name [1] 319622 0
Country [1] 319622 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 322125 0
Hospital
Name [1] 322125 0
Epworth Hospital
Address [1] 322125 0
Country [1] 322125 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318180 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318180 0
Ethics committee country [1] 318180 0
Australia
Date submitted for ethics approval [1] 318180 0
03/11/2025
Approval date [1] 318180 0
Ethics approval number [1] 318180 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143378 0
A/Prof Ashwin Subramaniam
Address 143378 0
Dandenong Hospital, Monash Health 135 David Street, Dandenong VIC 3175
Country 143378 0
Australia
Phone 143378 0
+61 3 9594 8334
Fax 143378 0
Email 143378 0
[email protected]
Contact person for public queries
Name 143379 0
A/Prof Ashwin Subramaniam
Address 143379 0
Dandenong Hospital, Monash Health 135 David Street, Dandenong VIC 3175
Country 143379 0
Australia
Phone 143379 0
+61 3 9594 8334
Fax 143379 0
Email 143379 0
[email protected]
Contact person for scientific queries
Name 143380 0
Ashwin Subramaniam
Address 143380 0
Dandenong Hospital, Monash Health 135 David Street, Dandenong VIC 3175
Country 143380 0
Australia
Phone 143380 0
+61 3 9594 8334
Fax 143380 0
Email 143380 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, this study will not consider sharing individual participant data, as it involves a vulnerable patient population (cardiac surgery patients in intensive care), where additional privacy protections are warranted. Due to ethical considerations, including potential risks to confidentiality and the sensitive nature of health and psychological data, data sharing is not planned. Furthermore, the consent process did not include provisions for future data sharing, and doing so could conflict with the commitments made to participants.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.