Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000791639
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
20/07/2023
Date last updated
28/07/2024
Date data sharing statement initially provided
20/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing a Virtual Reality Psychosocial Intervention for Youth on Dialysis in New Zealand: A proof of concept study.
Scientific title
Developing a Virtual Reality Psychosocial Intervention for Youth on Dialysis in New Zealand: A proof of concept study.
Secondary ID [1] 309390 0
Nil known
Universal Trial Number (UTN)
U1111-1290-8507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease (CKD) 329621 0
Condition category
Condition code
Mental Health 326544 326544 0 0
Studies of normal psychology, cognitive function and behaviour
Renal and Urogenital 326853 326853 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will test the potential of virtual reality (VR) technology to enhance the psychosocial health of youth on dialysis. Twelve participants representing the dialysis population in New Zealand aged 18-24 years (extremities included) will be identified and invited to participate in the study. This study will evaluate the usability and acceptability of a Mindful Self-Compassion program delivered via VR by exploring dialysis youths' experiences, perceptions, and preferences.

We aim to identify critical areas of improvement that can enhance user engagement and satisfaction while also providing insights into potential therapeutic benefits associated with delivering psychosocial interventions using virtual reality. Additionally, this study will investigate the logistical considerations associated with implementing a home-based Virtual Reality Psychosocial intervention by assessing logistical challenges and constraints for recruitment and participation in the study. This mixed-methods study combines quantitative questionnaires that participants complete prior to and two weeks after the VR session and open-ended questions that participants complete after the session.

Methodology
Study participants and recruitment
The aim is to recruit 12 young dialysis patients (either haemodialysis or peritoneal dialysis). DHB staff will identify potential participants, and the University of Auckland researchers will invite them, asking the renal clinic to provide PIS and study information along with contact information for the research team. In this invitation email, eligible participants will also receive the PIS and consent forms which they can sign and return in a pre-paid envelope or via email. We plan to recruit men and women from various ethnic groups using a purposive sampling frame. Participants are invited from all age groups, from 18-24, with a wide socioeconomic/rural distribution. Youths with severe psychiatric or developmental disorders and youth with visual impairments or physical disabilities that prevent them from using VR are excluded.

Participants: Purposeful sampling
(i) A group of 12 participants (aged 18-24) was selected;
(ii) males and females were equally represented in each group;
(iii) A mix of ethnicities will be recruited, with a particular emphasis on recruiting Maori and Pasifika youth, disproportionately affected by chronic kidney disease.
(iv) Peritoneal dialysis/Hemodialysis PD/HD in each group to be included.

Recruitment Procedure
(i) Invitations to participate will be made to potential participants by the UoA Research Team after the initial dissemination of research study information using letters, posters, and emails distributed by clinical nurses and patient support staff within the DHBs. Interested potential participants will be asked to contact the research team.
(ii) Eligible participants can give informed consent by emailing/posting consent forms before or during the home visit when the VR headsets are delivered before baseline assessments are taken.

Study design
This mixed methods proof-of-concept study explores the usability and acceptability of a brief MSC intervention delivered via VR. Quantitative measures will be collected to assess baseline demographic and clinical characteristics. Psychosocial questionnaires will also be collected at baseline and post-intervention. Open-ended questions will be administered after the intervention and analysed qualitatively to explore the user experience of the intervention and VR technology.

Study Procedure
The research team will visit interested participants a week before the VR group session. At this home visit, participants will be asked to provide informed consent (if they still need to do so) and receive a demonstration of the VR tool and headset. Baseline assessments will also be carried out (by the student researcher and the research assistant). The following week, the intervention will be conducted with approximately six participants per group. Each single group session will last approximately 75 minutes: 60 minutes of intervention with a 15-minute break after 30 minutes. Participants will take part in the intervention either from their home (if they have Wi-Fi and a private room to use) or from the University of Auckland Department of Psychological Medicine, where the PhD student and the intervention facilitator will also be based when the VR session is conducted. In the home-visit participants are also introduced to a Relaxation Meditation app which comprise of 5 or 10 minutes session. They are asked to experience the meditation app in their free time at least once. The participants and the facilitator will sign into the 'Connect' VR Application developed by XRHealth, an Australian digital innovation company offering FDA-approved VR applications. 'Connect' allows people to participate in a group session via VR remotely. Participants choose an avatar to represent themselves and participate in the virtual group session with VR headsets.

A postdoctoral researcher from the Department of Psychological Medicine familiar with MSC will facilitate the group session with Senior Lecturer in Health Psychology using the VR portal. At the start of the VR session, they will provide a verbal introduction to outline procedures and guidelines and answer any questions participants may have. Participants will also be encouraged to ask questions anytime during the session. During the group session, the facilitators will go through the different components of MSC (mindfulness, compassion, and shared humanity) and take the group through several exercises. After 30 minutes, the facilitators will suggest a 15-minute break and check how the participants find the session and the VR headset. The remaining session will last another 30 minutes and will cover similar topics. See below for a table of topics covered in the VR session. All participants will receive a $20 Countdown voucher during the home visit and a $50 Countdown voucher (post-study) as a koha to thank them for their time with the research. The intervention is discussed in more detail below.
1) The following questionnaires will be administered at the baseline home visit and two weeks after the intervention (over Qualtrics, a secure research website). We will also assess demographic and clinical measures at baseline, including ethnicity (using NZ census questions), age, sex, age when diagnosed, comorbidities, and treatment.
The following questionnaires will be assessed at baseline and after the VR group session.
• Self-Compassion Scale short form
• WHO-5 Wellbeing scale
• Five Facet Mindfulness Questionnaire (FFMQ-15)
The following questionnaires will only be asked after the VR group session.
• Modified (customised for the study) System Usability Scale (SUS)
• Participants will also be asked several open-ended questions to explore what they learnt from the intervention and if they have used any of the skills or exercises (e.g., "Over the past two weeks, have you used any of the skills that you learned from the VR session?")

VR Session:
Components of the brief self-compassion intervention :
Session One
Icebreaker game: "One Truth & One Lie Statement" - 10 minutes
Topic: Basic introduction on what mindful self-compassion is - 5 minutes
Topic: Crossing the line
Exercise: Peer discussion - 15 minutes

BREAK - 10 minutes
Session Two
Exercise: How would I treat a friend? - 15 minutes
Feedback session on the Relaxation Meditation Application - 10 minutes
Summary & Closing: 5 minutes

Attendance checklists and phone calls (2 hours prior) to the intervention will be carried out.
Intervention code [1] 325827 0
Behaviour
Comparator / control treatment
'No control group' as participants are purposeful sampled and its a proof of concept study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334385 0
Mental Wellbeing outcome
• Self-Compassion Scale short form
Timepoint [1] 334385 0
Assessed at baseline (pre-VR) and 2 weeks after the VR group session
Primary outcome [2] 334708 0
• WHO-5 Wellbeing scale
Timepoint [2] 334708 0
Assessed at baseline (pre-VR) and 2 weeks after the VR group session
Primary outcome [3] 334709 0
• Five Facet Mindfulness Questionnaire (FFMQ-15)
Timepoint [3] 334709 0
Assessed at baseline (pre-VR) and 2 weeks after the VR group session
Secondary outcome [1] 420457 0
Acceptability and Usability Outcome on the VR Tool/Technology
• Modified (customised for the study) System Usability Scale (SUS)
Timepoint [1] 420457 0
Assessed at baseline (pre-VR) and 2 weeks after the VR group session
Secondary outcome [2] 422479 0
Participants will also be asked several open-ended questions (customised and developed specifically for the purposes of this study) to explore what they learnt from the intervention, usability, safety and acceptability of the technology and Mindful Self-Compassion.
Timepoint [2] 422479 0
Assessed after 2 weeks Post VR group session

Eligibility
Key inclusion criteria
Participants between the ages of 18-24 years who are undergoing dialysis (haemodialysis and peritoneal dialysis) in New Zealand will be sought for inclusion.
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A prior exclusion criteria were defined as follows:
1) youth with severe psychiatric or developmental disorders.
2) youth with visual impairments or physical disabilities which prevents them from using VR.

Patient whom are transplanted and don't belong to the cohort group

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The quantitative measures (baseline demographic and clinical measures and psychosocial outcomes) will be reported using means and standard deviations. The study is not powered to look at efficacy as this is a proof-of-concept study, therefore we will not be exploring differences between baseline and post-intervention. The open-ended questions will be analysed using qualitative content analysis to explore participants’ experiences of the VR session. The recorded VR group session will also be analysed to further explore usability and acceptability of the group session including questions asked about the session content and any reported challenges using the technology.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/07/2023
Date of last participant enrolment
Anticipated
25/08/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
10
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 25378 0
New Zealand
State/province [1] 25378 0
Auckland

Funding & Sponsors
Funding source category [1] 313585 0
University
Name [1] 313585 0
The University of Auckland
Country [1] 313585 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Sciences, University of Auckland,
Building 507, Level 2, Department of Medicine,
85 Park Road, Grafton, Auckland 1023,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315370 0
Other Collaborative groups
Name [1] 315370 0
XR Health Australia
Address [1] 315370 0
Suite 101/135 Bamfield Rd, Heidelberg West VIC 3081, Australia
Country [1] 315370 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312763 0
AUCKLAND HEALTH RESEARCH ETHICS COMMITTEE (AHREC)
Ethics committee address [1] 312763 0
Ethics committee country [1] 312763 0
New Zealand
Date submitted for ethics approval [1] 312763 0
06/04/2023
Approval date [1] 312763 0
29/05/2023
Ethics approval number [1] 312763 0
AH25730

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

Contacts
Principal investigator
Name 125822 0
Ms Kavitha Jaganathan
Address 125822 0
35, Level 2, Building 507,
Faculty of Medical and Health Sciences, University of Auckland,
85 Park Road, Grafton, Auckland 1023,
Country 125822 0
New Zealand
Phone 125822 0
+64 0221500907
Fax 125822 0
Email 125822 0
[email protected]
Contact person for public queries
Name 125823 0
Kavitha Jaganathan
Address 125823 0
35, Level 2, Building 507,
Faculty of Medical and Health Sciences, University of Auckland,
85 Park Road, Grafton, Auckland 1023,
Country 125823 0
New Zealand
Phone 125823 0
+64 0221500907
Fax 125823 0
Email 125823 0
[email protected]
Contact person for scientific queries
Name 125824 0
Anna Serlachius
Address 125824 0
507-3020, Level 3, Building 507,
Faculty of Medical and Health Sciences, University of Auckland,
85 Park Road, Grafton, Auckland 1023,
Country 125824 0
New Zealand
Phone 125824 0
+6493737599
Fax 125824 0
Email 125824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19047Study protocol  [email protected] 385691-(Uploaded-02-05-2023-08-17-18)-Study-related document.pdf



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.