Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000745640
Ethics application status
Approved
Date submitted
27/06/2023
Date registered
10/07/2023
Date last updated
10/07/2023
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Supercharging Chronic Pain Education: The Experiential Immersive Education (iED) Project using Virtual Reality
Scientific title
Supercharging Chronic Pain Education: Efficacy of Experiential Immersive Education (iED) using Virtual Reality for Pain Beliefs in Adults with Chronic Non-Cancer Pain
Secondary ID [1] 309992 0
Nil known.
Universal Trial Number (UTN)
U1111-1294-2970
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pain 330487 0
Condition category
Condition code
Anaesthesiology 327335 327335 0 0
Pain management
Public Health 327408 327408 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three-arm experimental randomised control trial, using mixed method approaches.

1. Experiential Immersive Education (iED): Participants randomly allocated to the intervention group will undertake six therapist-led, 1-hour Virtual Reality sessions over 6-week period.
Sessions: One session per week for six weeks (6 in total)
Session Duration: 1 hour involving 20mins of Virtual Reality and 40 min of clinician guided reflection and workbook completion.
VR Treatment Content: the software protocol has been developed by company Reality Health. There are four modules: Understanding Pain, Retrain your body, Retrain your brain, Rehab. Each module involves pain system education and immersive experiences to demonstrate how the pain system works.
Workbook Content: designed specifically for this study, it repeats key messages from each VR education session and a self-management activity such as: goal setting, developing a home movement program, reflecting on learnings in the VR session. It also contains further self-directed resources related to pain management (e.g. videos, online pain mx programs).
Location: The sessions will be conducted in a community health clinic and facilitated by an allied health clinician experienced in pain management therapy.
Adherence to the intervention will be recorded by a session attendance checklist.

2. Minimal Intervention Control: This intervention involves novel pain education books which engage patients in a new understanding of pain through metaphors and visual illusions.
Sessions: A four week period to read two pain education books and complete a workbook.
Session duration: No specific time limit provided, participants work through at own pace.
Location: In own home environment
Book Content: a) Painful yarns : metaphors & stories to help understand the biology of pain / by G. Lorimer Moseley. Canberra : Dancing Giraffe Press, 2007 113 p
b) Pain and Perception: a closer look at why we hurt / by Daniel S Harvie and G. Lorimer Moseley. Noigroup Publications, 2021, 41 p
Workbook content: designed specifically for this study, it has the same activities as the VR workbook such as goal setting, developing a home movement program, and self-directed resources related to pain management (e.g. videos, online pain management programs). It differs without the key messages, and instead prompts reflections from the reading material about the pain system.
Adherence to this intervention will assessed by a self-report questionnaire on percentage of book completion.
Intervention code [1] 326409 0
Rehabilitation
Comparator / control treatment
Active waitlist control group will be advised to continue with their regular, community based health care for their pain condition, and will remain on the waitlist to access pain management care. They will be asked to complete the outcome measures at baseline, 8 weeks post randomisation and 26 weeks post randomisation. At the completion of the outcome measures at Time 3 (26 weeks post randomisation), they will be offered the VR intervention with a member of the research team (optional).
Control group
Active

Outcomes
Primary outcome [1] 335205 0
Change in pain beliefs, assessed using the Concept of Pain Inventory-Adult (COPI-A).
Timepoint [1] 335205 0
Baseline, one-week post completion of the intervention (primary timepoint), and at 26 weeks post randomisation.
Secondary outcome [1] 423446 0
Change in pain and disability levels. This will be assessed as a composite outcome, using the Brief Pain Inventory (BPI)-Modified.
Timepoint [1] 423446 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [2] 423447 0
Change in depression levels assessed using the depression subscale of the Depression Anxiety Stress Scale (DASS-21).
Timepoint [2] 423447 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [3] 423448 0
Change in pain self-efficacy assessed using the Pain Self Efficacy Questionnaire (PSEQ).
Timepoint [3] 423448 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [4] 423449 0
Change in pain catastrophising, assessed using the Pain Catastrophising Scale (PCS).
Timepoint [4] 423449 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [5] 423450 0
Change in pain-related fear of movement assessed using the Tampa Scale for Kinesiophobia: 11 (TSK-11).
Timepoint [5] 423450 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [6] 423451 0
Change in patients' understanding of pain neurophysiology assessed using the Revised Neurophysiology of Pain Questionnaire (NPQ).
Timepoint [6] 423451 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [7] 423452 0
Global rating of change, assessed using the Patient Global Impression of Change (PGIC).
Timepoint [7] 423452 0
One-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [8] 423453 0
Level of Satisfaction with Treatment.

Satisfaction with Treatment will be measured using a 6-point scale (0=strongly disagree and 5=strongly agree), to rate 4 items: ease of use of the intervention (VR or book), enjoyment of the intervention, whether the intervention helped with pain coping, and desire to continue using the intervention. These 4 items will be summed to create a total satisfaction score. Additionally, 1 item will assess likelihood to recommend the intervention (0=definitely not recommend and 10=definitely would recommend).
Timepoint [8] 423453 0
One-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [9] 423689 0
Change in anxiety levels, assessed by the anxiety subscale of the Depression Anxiety Stress Scale (DASS-21).
Timepoint [9] 423689 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation.
Secondary outcome [10] 423690 0
Change in stress levels, assessed by the stress subscale of the Depression Anxiety Stress Scale (DASS-21).
Timepoint [10] 423690 0
Baseline, one-week post completion of the intervention, and at 26 weeks post randomisation

Eligibility
Key inclusion criteria
• Be 18 years of age or older
• Have experienced chronic non-cancer pain for longer than 6 months;
• Be proficient in written and spoken English;
• Have a referral to the Gold Coast Interdisciplinary Persistent Pain Centre, triaged as a category 3 (routine)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have an untreated and unstable mental health condition that would prevent engagement;
• Be scheduled for surgical treatment related to their pain condition within next 6 months / study period
• Be undergoing treatment from other specialist services for the same pain problem
• Accepted under Workcover or actively involved in litigation
• Have been engaged with a multidisciplinary pain service within the last 12 months.
• Have significant medical/sensory issues (hearing or visual loss, vestibular difficulties) affecting their ability to participate in the intervention
• Have a significant cognitive impairment of sufficient severity that would affect the ability to self-manage their condition

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 will involve contacting the holder of the allocation schedule who is "off-site" at the main hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be completed using the ‘ralloc’ function of STATA, which provides a sequence of treatments randomly permuted in blocks of several sizes. The size and order of the blocks is also random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Based on a small to medium effect size for the primary outcome (Partial eta squared = 0.03, alpha = 0.05, power = 0.8) a minimum sample size of 69 was estimated to be required (see figure below). To account for potential dropouts and the increased likelihood of Type II error resulting from multiple outcomes and analyses, a sample of 90 participants will be targeted. This also satisfies the needs of the qualitative aspect of the study, where sufficiently large (e.g., n=20) samples are required to achieve saturation of themes.

Data Analysis: Quantitative outcomes relating to pain and pain beliefs will be analysed in SPSS statistical software suite, using a series of 2(Group: Intervention vs. Wait List) x 2(Time: Pre- vs. Post-Intervention) mixed ANOVAs. Significant between group differences will be probed using planned pairwise comparisons and descriptive statistics. The analyst will be blinded to group allocation. Qualitative outcomes will undergo a reflextive thematic analysis using transcripts of recorded interviews. Themes will be arranged and analysed using NVivo qualitative data analysis software package. Should the final data set contain >5% missing data for the primary outcome, a multiple imputation method will be used to replace missing values. To explore the potential mechanisms of benefit, we will undertake a mediation analysis using the third-party PROCESS plug-in for IBM SPSS. Here, we will examine whether change in psychological and clinical outcomes (self-efficacy, pain catastrophising, disability, pain) are mediated by changes in pain beliefs (rNPQ, COPI).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2023
Actual
Date of last participant enrolment
Anticipated
3/10/2023
Actual
Date of last data collection
Anticipated
9/04/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24991 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 40648 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 314171 0
Hospital
Name [1] 314171 0
Gold Coast Hospital (Gold Coast Health Collaborative Research Grant)
Country [1] 314171 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
1 Hospital Bvld, Southport
QLD
4215
Country
Australia
Secondary sponsor category [1] 316087 0
None
Name [1] 316087 0
Address [1] 316087 0
Country [1] 316087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313299 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313299 0
Office for Research Governance & Development
Level 2, PED Building
1 Hospital Boulevard, Southport, QLD, 4215
Ethics committee country [1] 313299 0
Australia
Date submitted for ethics approval [1] 313299 0
11/04/2023
Approval date [1] 313299 0
12/06/2023
Ethics approval number [1] 313299 0
HREC/2023/QGC/95111

Summary
Brief summary
This project aims to determine the impact of Experiential Immersive Education (iED) delivered via Virtual Reality for people with chronic pain. The project will examine the extent and nature of altered pain beliefs and attitudes after the iED treatment, and will explore perceptions of acceptability and utility.

Objectives:
1. To quantify change in pain attitudes and beliefs following iED, relative to a weight-list, and minimal intervention control.
2. To establish iED feasibility, acceptability and preliminary efficacy
3. To explore potential mechanism of effect


We hypothesise, that:
1. iED will lead to greater positive changes in pain beliefs and attitudes, than either control groups
2. iED will appear feasible, acceptable, and effective; and
3. Improvements in pain and disability will be mediated by fear of pain, pain catastrophising, and self-efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127658 0
Dr Darren Doherty
Address 127658 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive
Robina
QLD 4226
Country 127658 0
Australia
Phone 127658 0
+61756809583
Fax 127658 0
Email 127658 0
darren.doherty@health.qld.gov.au
Contact person for public queries
Name 127659 0
Dr Darren Doherty
Address 127659 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive
Robina
QLD 4226
Country 127659 0
Australia
Phone 127659 0
+61756686825
Fax 127659 0
Email 127659 0
darren.doherty@health.qld.gov.au
Contact person for scientific queries
Name 127660 0
Mrs Hannah Kennedy
Address 127660 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive
Robina
QLD 4226
Country 127660 0
Australia
Phone 127660 0
+61756809532
Fax 127660 0
Email 127660 0
hannah.kennedy@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
Individual participant data will not be made available, however de-identified group data can be made available upon reasonable request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19545Ethical approval  hannah.kennedy@health.qld.gov.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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