About this trial
Introduction: Chronic pain significantly impacts quality of life and requires comprehensive management strategies. Traditional pain education programs are beneficial but often require significant and prolonged patient engagement. Virtual reality (VR) offers a novel approach by creating immersive environments that may enhance the effectiveness of pain education. This protocol outlines a feasibility study to investigate the use of a Virtual Reality (VR) pain education program for people living with chronic pain (PwCP).
Aim of the investigation: To evaluate the feasibility and acceptability of delivering a VR pain education program for PwCP. The secondary aim will explore the pre-to-post-test changes in clinical outcomes as proof of concept for a future larger scale investigation.
Methods: We will use Reality Health™ as the VR tool to deliver pain science education. The study will be conducted as a single-arm feasibility study using a pretest:posttest design. Fifty PwCP will engage in the six-week Reality Health™ programme. This education programme focuses on the neurophysiology of pain, pain modulation techniques, cognitive-behavioural strategies and guided virtual exercises.
Results: Primary outcome measures will include the feasibility, acceptability and safety of Reality Health™ including recruitment, retention, intervention adherence and attrition rates. Secondary outcomes will explore the pre-to-post-test changes in outcome measures relating to pain intensity, pain interference, pain self-efficacy, pain self catastrophizing, quality of life and depression as proof of concept for a future larger scale investigation.
Conclusions: Results will establish the feasibility, acceptability and safety of using Reality Health™ in the treatment of chronic pain, informing a future randomised control trial.
Ethical approval: Ethics has been granted from University College Dublin's Human Research Ethics Board (HREC-LS-25-868587).
Acknowledgements: This work is funded through the Interreg north-west Europe project 'Scale-Up Rehab,'approved and funded by the European Commission \[NWE0100082\].
Disclosures: None.
Keywords: Virtual Reality, Chronic Pain, Pain Education, Feasibility Study, Protocol
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Diagnosed with chronic pain by a consultant in pain medicine or a general practitioner with any type of chronic pain for at least 3 months
Report a pain intensity of >3 on a Numerical Rating Scale
Be proficient in written and spoken English
Disqualifiers
Not able to provide informed consent
Scheduled for surgical treatment related to their pain condition within the next 6 months
Have a medical/psychiatric condition that would prevent engagement in the pain education programme
Trial design
Single group
Treatments tested in this trial
6-Week Virtual reality-delivered pain science education and behavioural pain management program
Other interventionEach participant will receive a six-week VR pain education program delivered via Reality Health™ software. Each session will last for 1 hour (one hour / week for six weeks).
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity Numerical Rating Scale
The Pain Intensity Numerical Rating Scale (Pain NRS) will be used to measure participant's average pain intensity over the previous seven days.
Brief Pain Inventory (BPI)
The BPI has been shown to be a valid tool for assessing pain interference with acceptable internal consistency reported. Excellent test-retest reliability has also been reported in a chronic pain cohort. A reduction of one point on the interference scale has been recommended as a clinically meaningful change (Cleeland et al 1994).
Beck Depression Inventory (BDI)
The BDI measures emotional, cognitive, and physical symptoms of depression. A reduction of five points on the BDI is generally considered a clinically meaningful improvement in depressive symptoms. The BDI has demonstrated strong internal consistency and excellent test-retest reliability across various populations, including those with chronic pain. (Beck et al 1961).
Pain Self-Efficacy Questionnaire (PSEQ)
Pain self-efficacy has been reported to be an independent predictor of disability and quality of life after controlling for pain intensity. Analyses have shown the PSEQ to have excellent internal consistency and test-retest reliability (Nicholas et al 2007)
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