Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001368729p
Ethics application status
Submitted, not yet approved
Date submitted
25/09/2022
Date registered
25/10/2022
Date last updated
25/10/2022
Date data sharing statement initially provided
25/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality immersion therapy for symptom management in Palliative Care inpatients: feasibility trial.
Scientific title
Virtual reality immersion therapy for symptom management in Palliative Care inpatients: feasibility trial.
Secondary ID [1] 308034 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Terminal illness 327713 0
Pain 327825 0
Anxiety 327826 0
Dyspnoea 327827 0
Nausea 327828 0
Depression 327829 0
Condition category
Condition code
Mental Health 324790 324790 0 0
Anxiety
Anaesthesiology 325044 325044 0 0
Pain management
Mental Health 325045 325045 0 0
Depression
Public Health 325046 325046 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will have a choice of Virtual Reality (VR) scenarios and initial duration (3 to 10 minutes) and frequency (once or twice daily). The scenarios will include a variety of different environment such as beach, urban areas, relaxing ambient, among others.
Ongoing sessions duration of each immersion and frequency will be guided by patients’ preferences within the above options. These sessions will be applied by a member of the research team, who will supervise the session.
Duration of therapy will be up to 14 days or until patient is either: a) discharged home, b) developed a contra-indication or complication of the therapy, c) withdrew wish to continue, d) deceased. Visor Immersive was the chosen device due to its portability, ease of use and available software. The headset along with the software were trialed by all members of the research team. Their application is simple and no formal training is required.
Decontamination of the device with disinfectant wipes will be performed before and after each session.
Allocation will be in a 2:1 ratio to intervention group and control group – for every 2 participants allocated to intervention group, 1 will be allocated to the control group.
Intervention code [1] 324485 0
Treatment: Devices
Comparator / control treatment
A small control group will receive standard symptomatic management at the treating physician discretion. This might include pharmacological and non pharmacological options depending on symptom nature and severity.
Control group
Active

Outcomes
Primary outcome [1] 332619 0
- To establish acceptability, tolerability and feasibility of VR immersion therapy in palliative care in-patients.
- The above will be established by validated questionnaire (Evaluation of Virtual Reality intervention)
Timepoint [1] 332619 0
The questionnaire will be applied once at day 3 post first VR session
Primary outcome [2] 332620 0
- To determine optimal duration and frequency, aka, “dosing”, of the immersion therapy
- Done also by answering Evaluation of Virtual Reality immersion questionnaire
Timepoint [2] 332620 0
The questionnaire will be applied once at day 3 post first VR session
Secondary outcome [1] 414075 0
- To collect data on symptoms incidence plus standard deviation
- Done by Symptom Assessment Score part of the Palliative Care Outcomes Collaboration (PCOC) questionnaire
Timepoint [1] 414075 0
- Twice daily for up to 14 days since commencement of VR therapy
Secondary outcome [2] 414076 0
- Initial clinical efficacy for change in symptoms
- Done by applying the Symptom Assessment Scale component of the PCOC questionnaire
Timepoint [2] 414076 0
- Twice daily for up to 14 days since commencement of VR therapy

Eligibility
Key inclusion criteria
- adult patient requiring treatment as palliative care in-patient
- alert and orientated
- expected to stay in hospital for more than 48 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- one or more episodes of delirium during this hospitalisation
- non-English speaking
- contra-indications to using VR device: severe vertigo, seizures, monocular vision, simulation sickness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (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
Safety/efficacy
Statistical methods / analysis
This is a feasibility trial, and the recommended sample size by the literature is 40-50 participants on the intervention group.
Data will be utilised to determine 1ry and 2ry objectives.
Comparison to control group will use statistical test appropriate for quantitative continuous data depending on satisfying or not conditions for parametric tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23206 0
Bethesda Hospital - Claremont
Recruitment postcode(s) [1] 38572 0
6010 - Claremont

Funding & Sponsors
Funding source category [1] 312294 0
Commercial sector/Industry
Name [1] 312294 0
Visor Immersive
Country [1] 312294 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Visor Immersive
Address
21 Simpson St, Perth WA 6005
Country
Australia
Secondary sponsor category [1] 313840 0
None
Name [1] 313840 0
Address [1] 313840 0
Country [1] 313840 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311663 0
University of Western Australia ethics committee
Ethics committee address [1] 311663 0
35 Stirling Highway
Perth WA 6009 Australia
Ethics committee country [1] 311663 0
Australia
Date submitted for ethics approval [1] 311663 0
13/07/2022
Approval date [1] 311663 0
Ethics approval number [1] 311663 0

Summary
Brief summary
The purpose of this study is to see if virtual reality immersion therapy can be further tested as a potential therapy for alleviating symptoms in palliative care patients while in hospital. The information obtained will help us to learn strategies, such as time and frequency of usage of therapy, to potentially help many patients in the future.

Study participation:

Participants will undergo virtual reality immersion sessions daily while in hospital. Twice daily symptom assessments will be done by the investigating team. Follow up questionnaire will be applied at day 3 since commencement of intervention (after discharge if that happens sooner). A small control group will also have symptoms assessments done twice daily.

Symptom assessments:

Participants will answer verbally a questionnaire grading symptoms from 0 to 10, which will happen twice daily. These will last between 5 to 20 minutes. From day 3 of participating, each participant will be asked, only once, questions related to their experience up until then including tolerability and the device and duration of therapy. This questionnaire will last 10 to 30 minutes.

Risks and side effects of the therapy are uncommon, but include dizziness, vertigo nausea, vomiting, anxiety and discomfort.

The benefits might include symptom improvement, but will certainly help us learning more about this possibly helpful therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121906 0
Dr Henrique Nicola
Address 121906 0
11 Robin Warren Dr
Murdoch 6015 WA
Fiona Stanley Hospital
Country 121906 0
Australia
Phone 121906 0
+61 415200040
Fax 121906 0
Email 121906 0
hnicola@me.com
Contact person for public queries
Name 121907 0
Dr Henrique Nicola
Address 121907 0
11 Robin Warren Dr
Murdoch 6015 WA
Fiona Stanley Hospital
Country 121907 0
Australia
Phone 121907 0
+61 415200040
Fax 121907 0
Email 121907 0
hnicola@me.com
Contact person for scientific queries
Name 121908 0
Dr Henrique Nicola
Address 121908 0
11 Robin Warren Dr
Murdoch 6015 WA
Fiona Stanley Hospital
Country 121908 0
Australia
Phone 121908 0
+61 415200040
Fax 121908 0
Email 121908 0
hnicola@me.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator - Dr Henrique Nicola
e-mail address: hnicola@me.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17179Study protocol  hnicola@me.com 384712-(Uploaded-19-10-2022-19-11-49)-Study-related document.docx
17180Informed consent form  hnicola@me.com 384712-(Uploaded-25-10-2022-11-47-53)-Study-related document.docx



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.