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
ACTRN12623000805673
Ethics application status
Approved
Date submitted
11/07/2023
Date registered
26/07/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Reality in Palliative Care Inpatients
Scientific title
Pilot study for the feasibility and acceptability of Virtual Reality Head Mounted Devices in Inpatients Receiving Palliative Care
Secondary ID [1] 310095 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 330657 0
Terminal illness 330658 0
Life-limiting illness 330659 0
Condition category
Condition code
Cancer 327469 327469 0 0
Any cancer
Respiratory 327470 327470 0 0
Chronic obstructive pulmonary disease
Cardiovascular 327471 327471 0 0
Other cardiovascular diseases
Neurological 327472 327472 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of virtual reality (VR) head mounted devices (HMDs) to place the patient in VR environments (photo or video) of their choice (indoor/outdoor, city/nature).
Palliative care inpatients will be recruited via an information flyer that has pictures of some of the VR environments available in the study.
VR experiences will be individual and provided face-to-face by palliative care nurses or doctors in the hospital.
It will be a one-off VR experience lasting approximately 30-60 minutes (including set-up and familiarisation with controllers) while the patient is in hospital.
Palliative care staff will be present with the patient throughout the VR experience to provide assistance if needed and to monitor acceptability and adherence.
Intervention code [1] 326495 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335341 0
Feasibility and acceptability of the use of VR HMDs in palliative care inpatients.
This will be assessed with semi-structured interviews conducted by a palliative care doctor or nurse who is also a member of the research team.
Interviews will take approximately 15-30 minutes and will be audio-recorded.
Timepoint [1] 335341 0
Assessed during a semi-structured interview immediately after the use of the VR device.
Primary outcome [2] 335343 0
Patients' thoughts about the VR experience they had just had and their ideas about what other kinds of VR experiences would appeal to them.
This will be assessed with semi-structured interviews conducted by a palliative care doctor or nurse who is also a member of the research team.
Interviews will take approximately 15-30 minutes and will be audio-recorded.
Timepoint [2] 335343 0
Assessed during a semi-structured interview immediately after the use of the VR device.
Secondary outcome [1] 424000 0
Pain assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [1] 424000 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [2] 424001 0
Tiredness assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [2] 424001 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [3] 424002 0
Drowsiness assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [3] 424002 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [4] 424003 0
Nausea assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [4] 424003 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [5] 424004 0
Lack of appetite assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [5] 424004 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [6] 424005 0
Shortness of breath assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [6] 424005 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [7] 424006 0
Depression assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [7] 424006 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [8] 424007 0
Anxiety assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [8] 424007 0
Assessed immediately before and after the use of the VR device.
Secondary outcome [9] 424008 0
Wellbeing assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
Timepoint [9] 424008 0
Assessed immediately before and after the use of the VR device.

Eligibility
Key inclusion criteria
Inpatients in hospital, admitted directly by the palliative care team, or being seen regularly by the palliative care consult team.
Able to read and understand English at a sufficient level to provide consent and follow directions for use of the VR headset.
Life-expectancy of less than 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients diagnosed with dementia
Patients experiencing delirium
Patients who are legally blind
Patients experiencing vertigo or motion 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Qualitiative data from semi-structured interviews will be collected. Interviews will be transcribed and studied via thematic analysis to identify subject areas from the VR experience that were of importance to patients.

An assessment of symptoms before and after the VR experience will be undertaken with the ESAS-R questionnaire, but the number of patients recruited for this feasibility study will not provide sufficient power to assess for statistically significant effects on symptoms. It will serve more as a prompt for patients to let us know if they are experiencing any symptoms and as an indication if the VR experience appears to affect these symptoms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2023
Actual
2/08/2023
Date of last participant enrolment
Anticipated
Actual
18/01/2024
Date of last data collection
Anticipated
Actual
18/01/2024
Sample size
Target
20
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25097 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 40767 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 314258 0
Charities/Societies/Foundations
Name [1] 314258 0
Our Community Cares Penrith
Country [1] 314258 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Derby St, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 316197 0
None
Name [1] 316197 0
Address [1] 316197 0
Country [1] 316197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313377 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 313377 0
Ethics committee country [1] 313377 0
Australia
Date submitted for ethics approval [1] 313377 0
05/06/2023
Approval date [1] 313377 0
29/06/2023
Ethics approval number [1] 313377 0

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

Contacts
Principal investigator
Name 127934 0
Dr Paul Lam
Address 127934 0
Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
Country 127934 0
Australia
Phone 127934 0
+61247343500
Fax 127934 0
Email 127934 0
p.lam@outlook.com
Contact person for public queries
Name 127935 0
Rebecca Palmer
Address 127935 0
Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
Country 127935 0
Australia
Phone 127935 0
+61428828050
Fax 127935 0
Email 127935 0
Rebecca.Palmer@health.nsw.gov.au
Contact person for scientific queries
Name 127936 0
Rebecca Palmer
Address 127936 0
Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
Country 127936 0
Australia
Phone 127936 0
+61428828050
Fax 127936 0
Email 127936 0
Rebecca.Palmer@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected will mainly be in the form of recorded interviews. It is not practical to make this information available publicly. De-identified information may also be recognisable by members of the public, for example, if they recognise a patient's voice.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19663Study protocol  Rebecca.Palmer@health.nsw.gov.au Please contact Rebecca Palmer if you wish to obtai... [More Details]
19664Informed consent form  Rebecca.Palmer@health.nsw.gov.au Please contact Rebecca Palmer if you wish to obtai... [More Details]



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.