Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000941460p
Ethics application status
Not yet submitted
Date submitted
3/08/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effect of Virtual Reality on Stress and Anxiety levels in Heart Surgery Patients Admitted to Intensive Care
Scientific title
The Impact of Virtual Reality Interventions on Stress and Anxiety: A Prospective Randomised Control Trial Among Cardiac Surgery Patients Admitted to Intensive Care
Secondary ID [1] 315054 0
None
Universal Trial Number (UTN)
Trial acronym
VR-I-CARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 338421 0
Anxiety 338629 0
Condition category
Condition code
Cardiovascular 334721 334721 0 0
Coronary heart disease
Surgery 334722 334722 0 0
Other surgery
Mental Health 334723 334723 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gamified and interactive Virtual Reality (VR) will be compared to a sham in a randomised controlled trial.
Patients will be recruited once they are extubated, able to provide informed consent, and suitable to participate in the VR intervention.
Experimental group: Participants will receive up to three VR sessions per day for a maximum of four consecutive ICU days, commencing within 48 hours post-extubation. Each VR session will last approximately 20 minutes.
Equipment: Sessions will be delivered using the Pico 4 Enterprise VR headset with noise-isolating earphones.
Content: Each session will feature (1) passive visual scenes with audio, (2) narrative-guided experience, and (3) light interactive experience (They will be able to engage with objects, activate scenes, complete puzzle challenges, and move through the story at their own pace, becoming active participants in the narrative).
Training/instructions: A short verbal orientation (5 minutes) will be provided immediately before the first VR session by a trained research assistant or ICU nurse, explaining how to use the VR headset and earphones.
Supervision: All VR sessions will be supervised by a research assistant or ICU nurse, who will assist as required and remove the device if the participant wishes to discontinue.
Choice of content: Participants will be able to choose among the available VR modules at each session ( on what suits them best, depending on their mental state, energy level, or mood that day).
Adherence monitoring: Adherence will be monitored via study logs and device usage analytics (session duration and frequency).
Intervention code [1] 331661 0
Treatment: Devices
Comparator / control treatment
Sham Group: Participants will wear the same headset with only ambient audio but no visuals or interactivity, matched in frequency and duration.
Participants will wear the same Pico 4 Enterprise headset and earphones for an identical frequency and duration of sessions. However, they will only receive ambient audio without visuals or interactivity.
Control group
Active

Outcomes
Primary outcome [1] 342376 0
Change in self-reported anxiety
Timepoint [1] 342376 0
Baseline and then immediately after each VR session (up to 12 sessions across 4 ICU days).
Secondary outcome [1] 450583 0
Stress levels
Timepoint [1] 450583 0
Baseline and then immediately after each VR session (up to 12 sessions across 4 ICU days)
Secondary outcome [2] 450584 0
Composite outcome comprising immersion, usability, and acceptability.
Timepoint [2] 450584 0
After the final VR session
Secondary outcome [3] 450585 0
Both subjective and objective measures of VR-related complications (e.g., headache, nausea, dizziness, pressure injuries from headset use). They will be assessed as a composite outcome.
Timepoint [3] 450585 0
Immediately after each VR session (12 sessions)
Secondary outcome [4] 450586 0
Patient satisfaction
Timepoint [4] 450586 0
After the last VR session
Secondary outcome [5] 450587 0
Use of pharmacological agents for sedation/anxiety
Timepoint [5] 450587 0
Daily, from ICU admission to ICU discharge.
Secondary outcome [6] 450588 0
ICU length of stay
Timepoint [6] 450588 0
Admission to hospital to discharge from hospital.
Secondary outcome [7] 450589 0
Delirium
Timepoint [7] 450589 0
Baseline and prior to each VR session (up to 12 sessions across 4 ICU days), and additionally if clinically relevant.
Secondary outcome [8] 450590 0
Feasibility of implementing VR in routine ICU care
Timepoint [8] 450590 0
Cumulative data will be assessed at the conclusion of recruitment
Secondary outcome [9] 451288 0
Staff satisfaction
Timepoint [9] 451288 0
After the trial has been completed at each site.
Secondary outcome [10] 451289 0
Hospital length of stay
Timepoint [10] 451289 0
Admission to hospital to discharge from hospital.

Eligibility
Key inclusion criteria
• Adults aged 18–80 years.
• Undergoing elective cardiac surgery (e.g., CABG, valve replacement or repair, combined).
• Admitted to ICU post-operatively and expected to remain for 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.
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)
Group allocation will be concealed using 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
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
Statistical methods / analysis
Sample Size and Analysis
Based on prior literature, we assume a medium effect size (Cohen’s d = 0.5), an alpha level of 0.05, two-tailed and 90% power to detect a clinically meaningful reduction in anxiety (HADS-A) of 1.5, with a standard deviation of 4.0. Based upon an independent samples t-test, power analysis, 86 patients per group would be required. Accounting for 20% attrition, a total of 218 participants (86/0.80 = 108.96 = 109 per group) will be recruited. We will estimate clustering to help power subsequent studies.

Statistical Analysis Plan
The analysis will adhere to the intention-to-treat principle. The primary outcome, change in anxiety as measured by the HADS-A, will be assessed using linear mixed-effects models. These models will account for fixed effects of time and group, as well as random intercepts for site to adjust for clustering across multiple centres, and to ascertain the magnitude of such clustering to aid sample size planning for future studies Secondary and tertiary outcomes will be analysed using appropriate statistical techniques, including logistic for binary outcomes and mixed-effects models for continuous repeated measures (Masaki et al., 2025). Subgroup analyses, following tests for statistical interaction (Altman & Bland, 2003) or classification and regression tree (CART) (Sharp et al., 2025), will be conducted based on age, sex, and type of surgery to explore potential differences in intervention effects across demographic and clinical subgroups. Qualitative data from patient and staff interviews will be analysed thematically to identify key patterns related to the feasibility, usability, and acceptability of the VR intervention. While statistical significance will be determined at the conventional threshold of p<0.05, the exploratory nature of this pilot study means greater emphasis will be placed on estimating effect sizes and 95% confidence intervals to inform the design of a future larger trial. All quantitative analyses will be performed using R and/or Stata statistical software and reported in accordance with CONSORT guidelines.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
218
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28280 0
Epworth Richmond - Richmond
Recruitment hospital [2] 28281 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 44495 0
3121 - Richmond
Recruitment postcode(s) [2] 44496 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 319621 0
Hospital
Name [1] 319621 0
Epworth Research Grant 2026 (Application No. RG000322026)
Country [1] 319621 0
Australia
Primary sponsor type
Hospital
Name
Epworth Hospital
Address
Country
Australia
Secondary sponsor category [1] 322124 0
None
Name [1] 322124 0
Address [1] 322124 0
Country [1] 322124 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318179 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318179 0
Ethics committee country [1] 318179 0
Australia
Date submitted for ethics approval [1] 318179 0
01/09/2025
Approval date [1] 318179 0
Ethics approval number [1] 318179 0

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

Contacts
Principal investigator
Name 143374 0
A/Prof Ashwin Subramaniam
Address 143374 0
Epworth Richmond Emergency Department 62 Erin Street, Richmond, VIC 3121
Country 143374 0
Australia
Phone 143374 0
+61 3 9506 3112
Fax 143374 0
Email 143374 0
[email protected]
Contact person for public queries
Name 143375 0
A/Prof Ashwin Subramaniam
Address 143375 0
Epworth Richmond Emergency Department 62 Erin Street, Richmond, VIC 3121
Country 143375 0
Australia
Phone 143375 0
+61 3 9506 3112
Fax 143375 0
Email 143375 0
[email protected]
Contact person for scientific queries
Name 143376 0
Ashwin Subramaniam
Address 143376 0
Epworth Richmond Emergency Department 62 Erin Street, Richmond, VIC 3121
Country 143376 0
Australia
Phone 143376 0
+61 3 9506 3112
Fax 143376 0
Email 143376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: 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.