Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001473550p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
NeuronsVR Virtual Reality therapy for people experiencing behavioural and psychological symptoms of dementia in acute hospital settings: a pilot randomised controlled trial
Scientific title
Evaluating the effect of NeuronsVR Virtual Reality therapy on dose and frequency of chemical restraint required for people experiencing behavioural and psychological symptoms of dementia in acute hospital settings: a pilot randomised controlled trial
Secondary ID [1] 313470 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 335876 0
Condition category
Condition code
Neurological 332463 332463 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual Reality (VR) therapy sessions using NeuronsVR headset.
The VR experiences are designed specifically for people with dementia, by VR experts and sound therapists in collaboration with aged and dementia care experts, including occupational therapists, gerontologists, and clinical neuropsychologists to ensure appropriate binaural beats, specific hertz vibrations and appropriate musical scores are applied. The NeuronsVR content is tailored to diverse preferences, offering experiences ranging from calming environments to more upbeat experiences (e.g. armchair travel, mediation, waterfalls, fishing, visiting a zoo, skiing etc). NeuronsVR library is built and continually updated based on requests for particular experiences.
Participants randomised into the intervention group will receive NeuronsVR therapy (a single VR session, approximately 10 minutes) once every 24-72hrs (every 1-3 days) up to 11 days in addition to usual care. The NeuronsVR therapy will be administered by an aged care nurse. Eleven days has been selected as this is the average length of stay (LOS) for patients with dementia at the research site. The maximum duration of the VR intervention will be 30 minutes allowing time for set up, VR delivery and post-intervention data collection. The VR intervention will last approximately 10 minutes and will be personalised to the participant using the South Eastern Sydney Local Health District (SESLHD) “Person Centred Profile/ TOP 5” form. This form is standard practice for all patients admitted to the aged care ward and does not form part of the study data collection. The form ask questions about the person’s life, likes, dislikes and things that cause distress. VR experiences appropriate to the participants interests are then selected from the library of available resources (for example walking through Italy or riding a motorbike).
Should the participant become distressed or indicate a desire to cease the experience, the RA will remove the headset and provide reassurance as required.
Intervention code [1] 330043 0
Behaviour
Intervention code [2] 330044 0
Treatment: Devices
Comparator / control treatment
Participants randomised into the control group will receive usual care.

Usual care interventions are selected and implemented on an individualised basis depending on patient need by the aged care nursing staff and aged care allied health staff. Usual care interventions are informed by the following clinical business rules (CBR): ‘Assessment and Management of Older Patients with Confusion and Delirium’, and a general ‘7 West Aged Care’ CBR with management strategies that would be relevant to the patient with behavioral and psychosocial symptoms of dementia (BPSD).

In the first CBR, it outlines non-pharmacological interventions such as nursing assessments to find the cause of the behaviour using the mnemonic ‘PINCHMECEASE’. This includes assessment of Pain, Infection, Nutrition, Constipation, Hydration, Medications, Environment/safety, Comfort, Environment/orientation, Activity, Social contact, and Engagement. Pharmacological interventions include oral risperidone and haloperidol, subcutaneous or intramuscular haloperidol, and finally, rapid sedation for safety; although these are suggested to be considered only after non-pharmacological measures have been exhausted.

In the 7 West Aged Care CBR, diversional therapies are suggested to assist with BPSD. These include strategies such as music therapy, diversional activity packs, television, and doll therapy and use of simulated pets. Pharmacological management should be established and documented by the medical team, although there are no set pathways or suggestions for the kinds of medication to be used or avoided.
Control group
Active

Outcomes
Primary outcome [1] 340003 0
Dose and frequency of sedatives (antipsychotics and benzodiazepines for chemical restraint purposes)
Timepoint [1] 340003 0
Collected during the intervention period.
Secondary outcome [1] 442268 0
Number of NeuronsVR therapy sessions attended including duration (intervention group)
Timepoint [1] 442268 0
Collected during the intervention period
Secondary outcome [2] 442269 0
Behavioural and psychosocial symptoms of dementia (BPSD)
Timepoint [2] 442269 0
At baseline and during the intervention period
Secondary outcome [3] 442270 0
Length of Stay (LOS)
Timepoint [3] 442270 0
Collected following patient discharge from hospital
Secondary outcome [4] 442271 0
Number of falls during hospital admission
Timepoint [4] 442271 0
Collected following patient discharge from hospital
Secondary outcome [5] 442272 0
Use of 1:1 close observation during admission
Timepoint [5] 442272 0
Collected following patient discharge from hopsital
Secondary outcome [6] 442273 0
Number of Code Blacks during admission
Timepoint [6] 442273 0
Collected following patient discharge from hospital
Secondary outcome [7] 442274 0
VR therapy safety- the presence or absence of adverse events
Timepoint [7] 442274 0
Collected during the intervention period

Eligibility
Key inclusion criteria
Patients are eligible to participate in this study if:
• they are admitted to an aged care ward at St George Hospital, NSW, Australia (7S, 7W and 3E)
• have a diagnosis of dementia
• are experiencing behavioural and psychosocial symptoms of dementia (BPSD) (BPSD tiers 3 to 7)
• are 50 years old and over
• are alert and score ‘A’ (alert) or ‘C’ (confusion/change in behaviour) on the ACVPU scale as per the NSW Health Standard Adult General Observation Chart
• BPSD Tiers 3 to 7
• can provide consent themselves, or have a substitute decision maker (SDM) who is able to provide consent should the patient be unable to do so
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include patients who:
• Score ‘V’ (verbal), ‘P’ (pain) or ‘U’ (unresponsive) on the ACVPU scale on the NSW Health Standard Adult General Observation Chart
• Are unable to safely wear the VR therapy headset (e.g. facial wounds)
• Are legally blind
• Have an infectious diseases requiring isolation (such as COVID-19, gastroenteritis and active tuberculosis)
• Have a history of seizures and/or epilepsy
• Are unable to provide consent and have no available substitute decision maker (SDM)
• Inability to sit up and remain seated for the duration of the VR therapy

Study design
Purpose of the study
Treatment
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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
4/08/2025
Actual
Date of last data collection
Anticipated
5/09/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27366 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 43459 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 317906 0
University
Name [1] 317906 0
University of Wollongong
Country [1] 317906 0
Australia
Funding source category [2] 317909 0
Commercial sector/Industry
Name [2] 317909 0
NeuronsVR Pty Ltd
Country [2] 317909 0
Australia
Primary sponsor type
Individual
Name
Amy Montgomery (University of Wollongong & St. George Hospital)
Address
Country
Australia
Secondary sponsor category [1] 320251 0
Hospital
Name [1] 320251 0
St George Hospital
Address [1] 320251 0
Country [1] 320251 0
Australia
Secondary sponsor category [2] 320255 0
Individual
Name [2] 320255 0
Gemma McErlean (University of Wollongong & St. George Hospital)
Address [2] 320255 0
Country [2] 320255 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316596 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316596 0
Ethics committee country [1] 316596 0
Australia
Date submitted for ethics approval [1] 316596 0
13/11/2024
Approval date [1] 316596 0
Ethics approval number [1] 316596 0

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

Contacts
Principal investigator
Name 138358 0
Dr Amy Montgomery
Address 138358 0
Building 41. University of Wollongong. Northfields Ave. Wollongong. NSW. 2522.
Country 138358 0
Australia
Phone 138358 0
+610287636487
Fax 138358 0
Email 138358 0
asaunder@uow.edu.au
Contact person for public queries
Name 138359 0
Amy Montgomery
Address 138359 0
Building 41. University of Wollongong. Northfields Ave. Wollongong. NSW. 2522.
Country 138359 0
Australia
Phone 138359 0
+610287636487
Fax 138359 0
Email 138359 0
asaunder@uow.edu.au
Contact person for scientific queries
Name 138360 0
Amy Montgomery
Address 138360 0
Building 41. University of Wollongong. Northfields Ave. Wollongong. NSW. 2522.
Country 138360 0
Australia
Phone 138360 0
+610287636487
Fax 138360 0
Email 138360 0
asaunder@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.