Trial Review

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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of virtual reality on quality of life in palliative care.
Scientific title
The effect of virtual reality on quality of life in palliative care: mixed methods study.
Secondary ID [1] 311152 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Life limiting illness 332316 0
Palliative Care 332405 0
Condition category
Condition code
Mental Health 329026 329026 0 0
Other mental health disorders
Neurological 329027 329027 0 0
Other neurological disorders
Cardiovascular 329102 329102 0 0
Other cardiovascular diseases
Respiratory 329103 329103 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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,
Intervention code [1] 327595 0
Rehabilitation
Intervention code [2] 327596 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336838 0
Quality of Life
Timepoint [1] 336838 0
Before commencement of the first VR session and after completing the last of the 3 VR interventions.
Primary outcome [2] 336839 0
Symptom Burden
Timepoint [2] 336839 0
Before commencement of each of the 3 sessions and immediately after completion of each of the 3 VR sessions
Secondary outcome [1] 429799 0
Patient experiences
Timepoint [1] 429799 0
Within 3 days after the final (third) VR session

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/10/2021
Date of last participant enrolment
Anticipated
Actual
23/06/2023
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
15
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25941 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 41775 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 315406 0
Charities/Societies/Foundations
Name [1] 315406 0
Breakthrough Mental Health Research Foundation
Country [1] 315406 0
Australia
Primary sponsor type
Individual
Name
Tobias Loetscher
Address
University of South Australia GPO Box 2471 Adelaide, South Australia 5001 Australia
Country
Australia
Secondary sponsor category [1] 317469 0
University
Name [1] 317469 0
University of South Australia
Address [1] 317469 0
University of South Australia GPO Box 2471 Adelaide, South Australia 5001 Australia
Country [1] 317469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314322 0
Central Adelaide Local Health Network (CAHLN)
Ethics committee address [1] 314322 0
Ethics committee country [1] 314322 0
Australia
Date submitted for ethics approval [1] 314322 0
19/08/2021
Approval date [1] 314322 0
13/09/2021
Ethics approval number [1] 314322 0
CALHN 15337
Ethics committee name [2] 314327 0
Human Research Ethics Committee University of South Australia
Ethics committee address [2] 314327 0
Ethics committee country [2] 314327 0
Australia
Date submitted for ethics approval [2] 314327 0
14/09/2021
Approval date [2] 314327 0
26/09/2021
Ethics approval number [2] 314327 0
204251

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

Contacts
Principal investigator
Name 131182 0
A/Prof Tobias Loetscher
Address 131182 0
University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
Country 131182 0
Australia
Phone 131182 0
+61 08 8302 9956
Fax 131182 0
Email 131182 0
tobias.loetscher@unisa.edu.au
Contact person for public queries
Name 131183 0
Tobias Loetscher
Address 131183 0
University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
Country 131183 0
Australia
Phone 131183 0
+61 08 8302 9956
Fax 131183 0
Email 131183 0
tobias.loetscher@unisa.edu.au
Contact person for scientific queries
Name 131184 0
Tobias Loetscher
Address 131184 0
University of South Australia, GPO Box 2471, Adelaide, SA 5001, Australia
Country 131184 0
Australia
Phone 131184 0
+61 08 8302 9956
Fax 131184 0
Email 131184 0
tobias.loetscher@unisa.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
Not included in ethics approval.


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.