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Trial registered on ANZCTR
Registration number
ACTRN12623001357640
Ethics application status
Approved
Date submitted
11/12/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Date results information initially provided
21/12/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of virtual reality on quality of life in palliative care.
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Scientific title
The effect of virtual reality on quality of life in palliative care: mixed methods study.
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Secondary ID [1]
311152
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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:
Life limiting illness
332316
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Palliative Care
332405
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Condition category
Condition code
Mental Health
329026
329026
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0
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Other mental health disorders
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Neurological
329027
329027
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0
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Other neurological disorders
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Cardiovascular
329102
329102
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0
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Other cardiovascular diseases
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Respiratory
329103
329103
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Three virtual reality sessions of around 20min were conducted over a period of approximately one week. Before the VR sessions, an interview was established meaningful content for participants. Questions explored preferences for places and experiences that participants would like to revisit, as well as music preferences. During the virtual reality sessions participants view the tailored virtual reality content with continual conversation occurring between the participant and researcher. The content was delivered using the Oculus Quest 2 headset. The VR experiences enabled participants to explore photorealistic global environments. Destinations spanned geographical points of personal interest, including famous landmarks (e.g. London Bridge, Great Pyramids). When exploring the VR experiences, they were asked to share their impressions and memories with the researcher.
To prevent possible triggering of distressing memories or experiences, participants were asked to focus only on positive memories during the session and in the interview. The researchers kept records of the content provided and time in VR,
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Intervention code [1]
327595
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Rehabilitation
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Intervention code [2]
327596
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Behaviour
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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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Quality of Life
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Assessment method [1]
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Functional Assessment of Chronic Illness Therapy (FACIT-Pal-14)
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Timepoint [1]
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Before commencement of the first VR session and after completing the last of the 3 VR interventions.
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Primary outcome [2]
336839
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Symptom Burden
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Assessment method [2]
336839
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Edmonton Symptom Assessment Scale-Revised (ESAS-R)
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Timepoint [2]
336839
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Before commencement of each of the 3 sessions and immediately after completion of each of the 3 VR sessions
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Secondary outcome [1]
429799
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Patient experiences
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Assessment method [1]
429799
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A semi-structured one-on-one interview was audio-recorded. The average interview time was about 10 minutes.
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Timepoint [1]
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Within 3 days after the final (third) VR session
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Eligibility
Key inclusion criteria
Inpatient male or female receiving palliative care and over the age of 18. Proficient English speakers. Able to tolerate wearing the head-mounted display and have vision that can be corrected with the use of their current glasses. Willing to undertake multiple assessments.
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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
Significant neurological disorders or psychotic disorders that would affect the ability to perform assessments. Those that have issues with confusion/disorientation at a level that would affect the ability to differentiate between virtual reality and the real world, or who may become distressed due to confusion re time and place
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
18/10/2021
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Date of last participant enrolment
Anticipated
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Actual
23/06/2023
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
15
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
25941
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Modbury Hospital - Modbury
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Recruitment postcode(s) [1]
41775
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5092 - Modbury
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Funding & Sponsors
Funding source category [1]
315406
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Charities/Societies/Foundations
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Name [1]
315406
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Breakthrough Mental Health Research Foundation
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Address [1]
315406
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Level 6/121 King William St, Adelaide SA 5000
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Country [1]
315406
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Australia
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Primary sponsor type
Individual
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Name
Tobias Loetscher
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Address
University of South Australia GPO Box 2471 Adelaide, South Australia 5001 Australia
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of South Australia
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Address [1]
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University of South Australia GPO Box 2471 Adelaide, South Australia 5001 Australia
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Country [1]
317469
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314322
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Central Adelaide Local Health Network (CAHLN)
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Ethics committee address [1]
314322
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Level 3, Roma Mitchell Building | 136 North Terrace, Adelaide, SA 5000
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Ethics committee country [1]
314322
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Australia
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Date submitted for ethics approval [1]
314322
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19/08/2021
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Approval date [1]
314322
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13/09/2021
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Ethics approval number [1]
314322
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CALHN 15337
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Ethics committee name [2]
314327
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Human Research Ethics Committee University of South Australia
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Ethics committee address [2]
314327
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GPO Box 2471, Adelaide, SA 5001, Australia
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Ethics committee country [2]
314327
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Australia
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Date submitted for ethics approval [2]
314327
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14/09/2021
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Approval date [2]
314327
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26/09/2021
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Ethics approval number [2]
314327
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204251
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Summary
Brief summary
Palliative care patients’ capacity to participate in meaningful activities may be limited and this can negatively impact their quality of life. A personalised Virtual Reality (VR) intervention was trialled in an inpatient palliative care setting to establish the effects of multiple VR sessions on quality of life and symptom burden in patients. The intervention encouraged participants to visit their choice of memorable and desired places. Participants completed three 20-minute VR sessions and the effects of the intervention on symptom burden and quality of life were measured.
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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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A/Prof Tobias Loetscher
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Address
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University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
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Country
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Australia
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Phone
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+61 08 8302 9956
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Fax
131182
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Email
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[email protected]
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Contact person for public queries
Name
131183
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A/Prof Tobias Loetscher
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Address
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University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
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Country
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Australia
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Phone
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+61 08 8302 9956
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Tobias Loetscher
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Address
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University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
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Country
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Australia
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Phone
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+61 08 8302 9956
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Fax
131184
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Email
131184
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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
Not included in ethics approval.
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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.
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