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Trial registered on ANZCTR


Registration number
ACTRN12621000732886
Ethics application status
Approved
Date submitted
8/04/2021
Date registered
10/06/2021
Date last updated
23/06/2024
Date data sharing statement initially provided
10/06/2021
Date results provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Immersive virtual reality intervention among patients receiving haemodialysis
Scientific title
Immersive virtual reality in a northern Queensland haemodialysis unit: A cross-over randomised controlled feasibility trial
Secondary ID [1] 303468 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage kidney disease 320785 0
Condition category
Condition code
Renal and Urogenital 318606 318606 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will explore the impact of an immersive virtual reality (VR) experience for patients attending a north Queensland haemodialysis service and provide information to inform a multi-centre randomised controlled trial (RCT). Over the 4-week (12 sessions) intervention period, participants undergoing haemodialysis 3 times/week with each session lasting approximately 4 hours at Townsville University Hospital in-centre dialysis unit and the satellite dialysis North Ward unit will be offered a headset with a choice of video. Each participant will have a headset for their own use for the duration of the intervention period. Infection prevention and control processes will be followed with respect to cleaning. Oculus Quest 2 is the headset that will be used in this study. This headset is cordless, without the need for any additional hardware. This maximizes safety within the clinical area where there is already a lot of equipment. Videos of the scenery of bushland, landscape, ocean representative of the areas where the participants come from will be offered. This intervention will be delivered by dialysis ward staff and members of the research team. Outcomes will be measured by participants’: attendance at scheduled dialysis sessions and adherence to lifestyle modifications; wellbeing, anxiety and depression; acceptability and usability of VR; cultural safety and adverse events such as nausea. The feasibility and acceptability of the equipment from the clinicians’ perspectives will also be explored. The control period will be four weeks duration and involve usual care, such as watching television, sleeping, reading. As this is a cross over trial the duration or 'wash out' period between treatments will be one week.
Intervention code [1] 319763 0
Treatment: Other
Comparator / control treatment
The active control group will receive the usual care, such as watching television, sleeping, reading during the study period.
Control group
Active

Outcomes
Primary outcome [1] 326580 0
- Attendance at scheduled dialysis sessions. This outcome will be assessed from patient medical records.
Timepoint [1] 326580 0
Patient outcomes will be collected at two timepoints: Week 5 (the week between intervention and control periods or vice versa), and week 10 (the week following completion of participation in the trial).
Secondary outcome [1] 391977 0
- Adherence to fluid allowances between dialysis sessions. This outcome will be assessed by intradialytic weight gain, defined as gaining on average, no more than one kilogram per day between dialysis sessions, as recorded in the medical record
Timepoint [1] 391977 0
Patient outcomes will be collected at two timepoints: Week 5 (the week between intervention and control periods or vice versa), and week 10 (the week following completion of participation in the trial).
Secondary outcome [2] 395258 0
Health related quality of life and engagement with self-care. This composite outcome will be assessed by the use of the Assessment of Quality of Life (AQoL) scale (6D).
Timepoint [2] 395258 0
Patient outcomes will be collected at three timepoints: at recruitment, Week 5 (the week between intervention and control periods or vice versa and Week 10 (the week following completion of participation in the trial.
Secondary outcome [3] 395260 0
Depression and anxiety. This outcome will be assessed by the amended Kessler Psychological Distress Scale - 5 (K-5). This is a composite outcome - the Kessler Psychological Distress Scale is a screening tool of general distress, and the questions relate to anxiety and depression related symptoms.
Timepoint [3] 395260 0
Patient outcomes will be collected at three timepoints: at recruitment, Week 5 (the week between intervention and control periods or vice versa and Week 10 (the week following completion of participation in the trial.
Secondary outcome [4] 395261 0
Usage of VR. This outcome will be measured by the percentage of dialysis occasions that patients use the VR headset, the amount of time within a session the participant used the headset, whether VR is used at the beginning, middle or towards the end of the dialysis sessions. These data are gathered by the headset and uploaded automatically from it.
Timepoint [4] 395261 0
Patient outcomes will be collected at two timepoints: Week 5 (the week between intervention and control periods or vice versa), and week 10 (the week following completion of participation in the trial).
Secondary outcome [5] 395262 0
Participants’ (clinicians) satisfaction with VR. This outcome will be measured by a questionnaire asking questions about the acceptability, feasibility, benefits and barriers to using VR in a haemodialysis setting. Due to the novelty of VR use in treatment environments, no appropriate standardised assessments for this population group currently exist although a few are reported in the peer-reviewed literature. Clinical staff will be asked to complete a survey adapted from Lindner et al (2019). This assessment asks about clinician familiarity with the medium both in and outside the clinical setting.
Respondents are presented with positive and negative aspects of the use of VR (eg patient mood improvement vs cost of technology) and asked how concerned they are about each issue. There is an option at the end of the questionnaire for open-ended answers on any other aspect staff may wish to comment upon.
Full reference for Linder et al. 2019:Lindner, P., Miloff, A., Zetterlund, E., Reuterskiöld, L., Andersson, G., & Carlbring, P. (2019). Attitudes towards and familiarity with virtual reality therapy among practicing cognitive behavior therapists: A cross-sectional survey study in the era of consumer VR platforms. Front Psychol. doi:https://doi.org/10.3389/fpsyg.2019.00176
Timepoint [5] 395262 0
Staff satisfaction will be collected after all patient intervention-control periods have been completed.
Secondary outcome [6] 396722 0
Acceptability and usability of VR. This is a composite secondary composite outcome. It will be measured with the User Engagement Scale - Short Form, modified and incorporated into a conversational interview.
Timepoint [6] 396722 0
This will be measured once, the week after the participant has completed the intervention phase

Eligibility
Key inclusion criteria
Patients 18 years or older; in treatment with 3 times weekly haemodialysis sessions; haemodialysis duration of 3 hours or greater; no history of severe migraines, and orientated to time and space.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing emergency dialysis; patients with significant visual impairment; patients with a significant history of migraines.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of clusters using a randomisation table created by computer software (i.e.using web-based computer program www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The quantitative data will be entered into an IBM SPSS software (SPSS) database (Version 25, Chicago). Chi-square tests will be used to analyse categorical data. Ordinal data will be analysed via rank tests. Paired t-tests and ANOVA will be used for continuous variables where appropriate. Where assumptions have been violated, non-parametric versions of tests will be used. If participants withdraw, attendance data will be analysed by intention-to-treat. Where appropriate modelling of outcomes will be undertaken in order to explain variability in results.

Notes taken from informal interviews with patients will be analysed deductively. Observational and summary notes taken by the investigators, and notes taken by the Stakeholder Group will also form part of the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2022
Actual
5/09/2022
Date of last participant enrolment
Anticipated
7/02/2023
Actual
9/12/2022
Date of last data collection
Anticipated
5/05/2023
Actual
18/02/2023
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19399 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 33194 0
4814 - Douglas
Recruitment postcode(s) [2] 33980 0
4810 - North Ward

Funding & Sponsors
Funding source category [1] 307885 0
Other Collaborative groups
Name [1] 307885 0
Tropical Australian Academic Health Centre
Country [1] 307885 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital and Health Service
Address
PO Box 650, Townsville, Queensland, 4810
Country
Australia
Secondary sponsor category [1] 308594 0
None
Name [1] 308594 0
None
Address [1] 308594 0
None
Country [1] 308594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307884 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 307884 0
Ethics committee country [1] 307884 0
Australia
Date submitted for ethics approval [1] 307884 0
22/02/2021
Approval date [1] 307884 0
11/03/2021
Ethics approval number [1] 307884 0
HREC/QTHS/72273

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

Contacts
Principal investigator
Name 108814 0
Dr Wendy Smyth
Address 108814 0
Townsville Institute of Health Research and Innovation,
Townsville University Hospital,
100 Angus Smith Dr, Douglas QLD 4814
Country 108814 0
Australia
Phone 108814 0
+61 07 44332666
Fax 108814 0
Email 108814 0
Wendy.smyth@health.qld.gov.au
Contact person for public queries
Name 108815 0
Wendy Smyth
Address 108815 0
Townsville Institute of Health Research and Innovation,
Townsville University Hospital,
100 Angus Smith Dr, Douglas QLD 4814
Country 108815 0
Australia
Phone 108815 0
+61 07 44332666
Fax 108815 0
Email 108815 0
Wendy.smyth@health.qld.gov.au
Contact person for scientific queries
Name 108816 0
Wendy Smyth
Address 108816 0
Townsville Institute of Health Research and Innovation,
Townsville University Hospital,
100 Angus Smith Dr, Douglas QLD 4814
Country 108816 0
Australia
Phone 108816 0
+61 07 44332666
Fax 108816 0
Email 108816 0
Wendy.smyth@health.qld.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


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
SourceTitleYear of PublicationDOI
EmbaseImmersive virtual reality in a northern Queensland haemodialysis unit: Study protocol for a cross-over randomized controlled feasibility trial (ACTRN12621000732886).2022https://dx.doi.org/10.1016/j.conctc.2022.100956
N.B. These documents automatically identified may not have been verified by the study sponsor.