Exploring the Feasibility of Using Virtual Reality as an Educational Tool in Chronic Pain Rehabilitation

Condition(s) studied

Investigational drug(s) / intervention(s)

6-Week Virtual reality-delivered pain science education and behavioural pain management program: Each 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).

Study summary

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

Primary outcome measure(s)

• Pain Intensity Numerical Rating Scale — All PROM data will be collected at three time points: - Before the 6-week VR education programme - Immediately after the 6-week VR education programme - 3 months after the 6-week VR education programme
  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) — All PROM data will be collected at three time points: - Before the 6-week VR education programme - Immediately after the 6-week VR education programme - 3 months after the 6-week VR education programme
  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) — All PROM data will be collected at three time points: - Before the 6-week VR education programme - Immediately after the 6-week VR education programme - 3 months after the 6-week VR education programme
  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) — All PROM data will be collected at three time points: - Before the 6-week VR education programme - Immediately after the 6-week VR education programme - 3 months after the 6-week VR education programme
  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)
• 12-Item Short Form Health Survey (SF-12) — All PROM data will be collected at three time points: - Before the 6-week VR education programme - Immediately after the 6-week VR education programme - 3 months after the 6-week VR education programme
  The 12-Item Short Form Health Survey (SF-12) is a validated instrument designed to measure health-related quality of life (HRQoL). It assesses both physical and mental health components through two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 has demonstrated strong internal consistency and test-retest reliability across diverse populations, including those with chronic conditions. A clinically meaningful change is typically represented by an increase of 3 to 5 points in either the PCS or MCS scores (Ware et al 1996).

Trial sites (1)

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