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Trial registered on ANZCTR
Registration number
ACTRN12623000805673
Ethics application status
Approved
Date submitted
11/07/2023
Date registered
26/07/2023
Date last updated
26/07/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Virtual Reality in Palliative Care Inpatients
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Scientific title
Pilot study for the feasibility and acceptability of Virtual Reality Head Mounted Devices in Inpatients Receiving Palliative Care
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Secondary ID [1]
310095
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Palliative Care
330657
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Terminal illness
330658
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Life-limiting illness
330659
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Condition category
Condition code
Cancer
327469
327469
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0
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Any cancer
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Respiratory
327470
327470
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0
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Chronic obstructive pulmonary disease
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Cardiovascular
327471
327471
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0
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Other cardiovascular diseases
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Neurological
327472
327472
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0
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326495
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Assessed during a semi-structured interview immediately after the use of the VR device.
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Primary outcome [2]
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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.
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Assessment method [2]
335343
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Timepoint [2]
335343
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Assessed during a semi-structured interview immediately after the use of the VR device.
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Secondary outcome [1]
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Pain assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [1]
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Timepoint [1]
424000
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [2]
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Tiredness assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [2]
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Timepoint [2]
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [3]
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Drowsiness assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [3]
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Timepoint [3]
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [4]
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Nausea assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [4]
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Timepoint [4]
424003
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [5]
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Lack of appetite assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [5]
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Timepoint [5]
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [6]
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Shortness of breath assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [6]
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Timepoint [6]
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [7]
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Depression assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [7]
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Timepoint [7]
424006
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [8]
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Anxiety assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [8]
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Timepoint [8]
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Assessed immediately before and after the use of the VR device.
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Secondary outcome [9]
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Wellbeing assessed using an 11-point (0-10) scale (Edmonton Symptom Assessment System - Revised).
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Assessment method [9]
424008
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Timepoint [9]
424008
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Assessed immediately before and after the use of the VR device.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients diagnosed with dementia
Patients experiencing delirium
Patients who are legally blind
Patients experiencing vertigo or motion sickness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/07/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
25097
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Nepean Hospital - Kingswood
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Recruitment postcode(s) [1]
40767
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2747 - Kingswood
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Funding & Sponsors
Funding source category [1]
314258
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Charities/Societies/Foundations
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Name [1]
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Our Community Cares Penrith
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Address [1]
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3 Buchanan Street
Jordan Springs NSW 2747
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Nepean Hospital
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Address
Derby St, Kingswood NSW 2747
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
316197
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Address [1]
316197
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Country [1]
316197
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313377
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Nepean Blue Mountains Local Health District HREC
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Ethics committee address [1]
313377
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The Chair, Human Research Ethics Committee
Research Office
PO Box 63
Penrith NSW 2750
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Ethics committee country [1]
313377
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Australia
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Date submitted for ethics approval [1]
313377
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05/06/2023
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Approval date [1]
313377
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29/06/2023
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Ethics approval number [1]
313377
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Summary
Brief summary
This study aims to assess the feasibility of making virtual reality (VR) experiences available to palliative care inpatients in a large tertiary hospital.
Who is it for?
You may be eligible for this study if you are a hospital inpatient admitted directly by the palliative care team, and have a life expectancy of less than 12 months.
Study details
Patients will be offered a one-off VR experience with a head mounted device (HMD), where they are immersed in different VR environments of their choice. Choices include indoor or outdoor scenes and urban or natural environments. There will be a brief interview afterwards to discuss what they thought about the experience.
It is hoped that patients will find this experience enjoyable and that the findings from this study will help elicit the preferences of this patient population with regards to the types of VR experiences they would be interested in, to guide the provision of future VR product offerings.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Paul Lam
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Address
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Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
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Country
127934
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Australia
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Phone
127934
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+61247343500
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Fax
127934
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Rebecca Palmer
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Address
127935
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Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
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Country
127935
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Australia
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Phone
127935
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+61428828050
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Fax
127935
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Email
127935
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[email protected]
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Contact person for scientific queries
Name
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Ms Rebecca Palmer
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Address
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Palliative Care Department
Nepean Cancer and Wellness Centre
Building O, Cnr Great Western Highway and Somerset St
Kingswood NSW 2747
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Country
127936
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Australia
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Phone
127936
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+61428828050
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Fax
127936
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Email
127936
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19663
Study protocol
[email protected]
Please contact Rebecca Palmer if you wish to obtai...
[
More Details
]
19664
Informed consent form
[email protected]
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.
Download to PDF