Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000843459
Ethics application status
Approved
Date submitted
2/01/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality Pain Education Program implementation study
Scientific title
Implementation of a clinician-led, immersive pain education program using Virtual Reality: a state-wide evaluation
Secondary ID [1] 313623 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is related to study ACTRN12623000745640, where the same VR intervention will be delivered across 5 pain management service sites, and evaluated using an implementation framework.

Health condition
Health condition(s) or problem(s) studied:
Pain management 336180 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332719 332719 0 0
Other physical medicine / rehabilitation
Public Health 332942 332942 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinician-led Virtual Reality based pain education and rehabilitation program.
Participants will complete six, 1-hour sessions over an 8 week period, Sessions are delivered in a 1:1 face to face consultation with an allied health or nursing clinician and involve the use of a Virtual Reality pain education software and accompanying workbook activities. The VR intervention is delivered using a Meta Quest 3 headset, and the software is the Reality Health Pain Management Program.

The VR pain education program treatment protocol and patient workbook (Supercharging Chronic Pain Education using VR Protocol) have been developed by Gold Coast Health in consultation with med-tech company Reality Health who developed and own the VR Reality Health software. The protocol and workbook were developed and tested during the initial single site RCT (ACTRN12623000745640), and the same protocol and workbook will be used during this multi-site implementation study. Adherence to the intervention will be monitored via session notes and software dashboard reporting.

This VR pain education program will be delivered by a range of pain management clinicians, with backgrounds in occupational therapy, physiotherapy, psychology and nursing at each of the 5 participating sites.

Reality Health and the Project Lead will provide training to the clinicians in the delivery of the VR treatment protocol as part of the implementation. The training schedule will involve 1 x 3 hour face to face workshop and practical VR sessions, protected time for self-guided practice of the VR modules, and practice use of the VR modules, over a one-three month period. Clinicians will aim to complete their training approximately one month prior to commencing delivery of the intervention to participants. The Project Lead will provide ongoing support for the duration of the pilot to the sites and clinicians, via formal monthly meetings, informal check ins, and online resources via a Sharepoint site.

The intervention will be delivered in the five tertiary-level public pain management services in Queensland, Australia. The services are outpatient hospital clinics, staffed by a multidisciplinary team. The intervention will be offered to participants as part of their pain management treatment options, until a total of 25 participants have been recruited at each site (125 total across 5 sites). There will be no randomisation or control group for this implementation study.
Intervention code [1] 330217 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340246 0
Reach (RE-AIM framework)
Timepoint [1] 340246 0
End of pilot implementation (12 months post study start date).
Primary outcome [2] 340594 0
Effectiveness (RE-AIM framework)
Timepoint [2] 340594 0
Baseline, post intervention (end of 6 sessions), 3 months follow up.
Primary outcome [3] 340595 0
Implementation (RE-AIM framework)
Timepoint [3] 340595 0
End of pilot implementation (12 months post study start date).
Secondary outcome [1] 443466 0
Adoption (RE-AIM framework) - primary outcome:
Timepoint [1] 443466 0
End of pilot implementation (12 months post study start date).
Secondary outcome [2] 444543 0
Maintenance (RE-AIM framework) - primary outcome
Timepoint [2] 444543 0
End of pilot implementation (12 months post study start date).

Eligibility
Key inclusion criteria
People living with chronic non-cancer pain for greater than 6 months duration, who have been referred to a tertiary-level, multidisciplinary persistent pain management service.
A total of 150 (125 patients and 25 clinicians) people will be invited to participate in the evaluation. Twenty-five patients will be invited from each study site. Patients will be invited to join the project, following an initial assessment with the pain service. Clinicians will be invited to participate in the study at completion of the study intervention.

Inclusion criteria for the VR pain education program will be:
- A current referral to any of the tertiary pain management services
- Aged 18 years or older
- Suitable goals to engage with a multidisciplinary rehab approach
- Able to attend 6 x 1 hour sessions to participate in Virtual Reality pain education program

Additionally, the study population will include clinicians involved in delivering and implementing the VR pain education sessions at each site. It is estimated 25 clinicians will participate in the evaluation.
Inclusion criteria for clinicians include:
- Employed at any of the five pain management service sites during delivery of the project
- Either: delivered the VR pain education program to participants during the project, and / or:
- Managed the team of clinicians who were delivering the VR pain education program during the project
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be:
- Insufficient English (reading level less than 10 years of age) to participate in an education session
- Significant cognitive or sensory impairment affecting ability to tolerate virtual reality (i.e. hearing, vision or vestibular issues)
- Unstable or untreated mental health condition impacting ability to engage with pain education

Exclusion criteria for clinicians include:
- Did not deliver the VR education program to participants or manage clinicians delivering the VR program during the project

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/01/2025
Date of last participant enrolment
Anticipated
21/01/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
150
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28249 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 28250 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 28251 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 28252 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 28253 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 44462 0
4215 - Southport
Recruitment postcode(s) [2] 44463 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 44464 0
4029 - Herston
Recruitment postcode(s) [4] 44465 0
4575 - Birtinya
Recruitment postcode(s) [5] 44466 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 318092 0
Government body
Name [1] 318092 0
Queensland Technology Futures Fund, Office of Research and Innovation, Queensland Health
Country [1] 318092 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 320450 0
None
Name [1] 320450 0
Address [1] 320450 0
Country [1] 320450 0
Other collaborator category [1] 283450 0
University
Name [1] 283450 0
Griffith University
Address [1] 283450 0
Country [1] 283450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316738 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 316738 0
Ethics committee country [1] 316738 0
Australia
Date submitted for ethics approval [1] 316738 0
14/08/2024
Approval date [1] 316738 0
08/10/2024
Ethics approval number [1] 316738 0
HREC/2024/QGC/111483

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

Contacts
Principal investigator
Name 138850 0
Mrs Hannah Kennedy
Address 138850 0
Interdisciplinary Persistent Pain Centre, 2 Investigator Drive, Robina, Queensland 4226
Country 138850 0
Australia
Phone 138850 0
+61 756686825
Fax 138850 0
Email 138850 0
[email protected]
Contact person for public queries
Name 138851 0
Hannah Kennedy
Address 138851 0
Interdisciplinary Persistent Pain Centre, 2 Investigator Drive, Robina, Queensland 4226
Country 138851 0
Australia
Phone 138851 0
+61 756686825
Fax 138851 0
Email 138851 0
[email protected]
Contact person for scientific queries
Name 138852 0
Hannah Kennedy
Address 138852 0
Interdisciplinary Persistent Pain Centre, 2 Investigator Drive, Robina, Queensland, 4226
Country 138852 0
Australia
Phone 138852 0
+61 756686825
Fax 138852 0
Email 138852 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.