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

Introduction:

Chronic pain is a persistent and complex condition that impacts approximately 20% of the global population, significantly affecting physical, emotional, and social well-being (Nicholas et al., 2019). Effective management strategies require addressing both the biological and psychosocial aspects of pain, as outlined by the biopsychosocial model of chronic pain (Turk and Monarch, 2002). Pain science education (PSE) has emerged as a critical non-pharmacological approach to chronic pain management, helping patients understand the mechanisms underlying pain and promoting adaptive coping strategies (Moseley and Butler, 2015). However, traditional PSE delivery methods, such as face-to-face sessions, can be time-intensive, resource-demanding, and challenging to scale. Innovative solutions, such as virtual reality (VR), offer a promising alternative for improving accessibility, engagement, and outcomes.

Pain Science Education:

PSE focuses on teaching individuals about the neurophysiology and neurobiology of pain to shift maladaptive beliefs and foster a greater sense of control over their condition (Moseley and Butler, 2015). Evidence suggests that PSE can reduce pain catastrophising, enhance self-efficacy, and improve quality of life (Moseley et al., 2004). The approach employs a variety of delivery strategies, including metaphors, visual aids, and experiential learning techniques, to facilitate understanding (Nijs et al., 2019). However, replicating the interactive and experiential nature of PSE in conventional settings can be challenging. VR's immersive capabilities can address these limitations by creating environments that visually and interactively demonstrate complex pain mechanisms, potentially enhancing patient understanding and retention (Ryan et al., 2018).

Virtual Reality in Healthcare:

VR has demonstrated significant potential in healthcare, particularly in acute and chronic pain management. Its applications range from pain distraction during medical procedures to therapeutic interventions that leverage neuroplasticity (Mallari et al., 2019). By engaging multiple sensory pathways, VR can modify pain perception and reduce reliance on pharmacological treatments (Li et al., 2011). Additionally, VR has been used successfully in psychological interventions, such as cognitive-behavioral therapy (CBT) for anxiety and post-traumatic stress disorder (PTSD), highlighting its versatility as a therapeutic tool (Freeman et al., 2017).

Integrating VR with PSE:

Integrating VR with PSE offers a novel approach to addressing the limitations of traditional pain education. VR environments can simulate dynamic, interactive experiences that visualize the workings of the nervous system and illustrate pain-modulation strategies in action. For instance, guided exercises in VR can help patients practice mindfulness, relaxation techniques, or graded exposure in an engaging and controlled manner (Spicher et al., 2022). The interactive nature of VR also fosters active learning, which is critical for behavior change and skill acquisition (Ryan et al., 2018).

Rationale for the Study:

While VR has been explored as a distraction tool in acute pain, its use in delivering comprehensive educational interventions for chronic pain remains underexplored. Preliminary studies indicate that VR-based education can enhance patient engagement and understanding of health information (Ferrer-García et al., 2016). However, evidence on its feasibility, acceptability, and clinical impact in chronic pain populations is limited. This study addresses this gap by evaluating the use of Reality Health™, a VR-based pain education program, as a scalable, interactive, and patient-centered approach to PSE. By focusing on feasibility and proof-of-concept outcomes, the findings will provide insights for a future randomised controlled trial, and the broader implementation of VR in chronic pain management.

Methodology:

This study will employ a mixed methods approach, integrating both quantitative and qualitative data to comprehensively evaluate the feasibility, acceptability, and preliminary clinical impact of a VR-based pain education programme. The study will be conducted as a single-arm feasibility study using a pretest-posttest design. A total of 50 PwCP will be recruited to engage in 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).

The Reality Health™ platform provides experiential learning content, sensory altering experiences, rehabilitation activities and immersive pain neuroscience education through four key modules. The platform uses the wireless Meta Quest VR headset and hand controls to engage with each module, and is delivered in a 1:1 clinician-led setting. The clinician guides the participant through the immersive VR modules, enables reflections and facilitates translation of knowledge to attitudes and behaviours that can drive positive outcomes.

A treatment protocol has been developed to deliver the Reality Health™ platform as a clinician-led pain education programme. The 'Supercharging Chronic Pain Education' treatment protocol delivers the VR intervention in six individual one-hour sessions with a clinician. Each session involves use of a Meta Quest headset to complete an immersive pain education module and individualised clinician-guided rehabilitation, with an accompanying patient workbook.

A qualitative study will be embedded within this design to explore individual experiences and perceptions of using VR for chronic pain education. Semi-structured focus groups will be conducted with a subset of participants post-intervention to gather in-depth insights into their acceptance of VR technology, its perceived benefits, and challenges. This qualitative component will provide rich contextual data, complementing the quantitative findings and addressing factors that influence the feasibility and acceptability of the intervention. Interviews will last 30-45 minutes in total.

Participant Recruitment Participants will be recruited through Chronic Pain Ireland (Irelands national charity supporting PwCP) and a Dublin University Hospital Pain Service.

Data Collection:

Data will be collected using both patient reported outcome measures (completed online or sent via pre-paid postage) and online/ via phone 1-1 semi-structured interviews.

The patient reported outcome measures will be completed pre, post and at the three month follow-up. These outcome measures will take an average of 35-40 minutes to complete.

Adverse events and participants' acceptability of the intervention will also be recorded.

The sample size of 50 participants for this feasibility study was determined based on practical considerations rather than statistical power calculations, as is common in feasibility studies.

Inclusion criteria include:

• 18 years old Diagnosed with chronic pain by a consultant in pain medicine or 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

Participants not able to provide informed consent or those awaiting surgery within the next 6 months will be excluded from the study.

Patient reported outcome measures include:

(i) 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.

(ii) Brief Pain Inventory (BPI) The BPI assesses pain interference with acceptable internal consistency reported. A reduction of one point on the interference scale has been recommended as a clinically meaningful change (Cleelend et al 1994).

(iii) Beck Depression Inventory (BDI) The BDI is a widely validated tool used to assess the severity of depressive symptoms. 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 BPI has demonstrated strong internal consistency and excellent test-retest reliability across various populations, including those with chronic pain (Beck et al 1961).

(iv) 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)

(v) 12-Item Short Form Health Survey (SF-12) 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).

The outcomes of interest relating to the feasibility and acceptability of the study recruitment, methodology and intervention will be as follows: recruitment, retention, attrition and adherence rates.

Recruitment: The overall recruitment rate will be calculated as a percentage, with the number of people enrolled (numerator) over the number of eligible participants (denominator). We will also assess and report upon the following in relation to recruitment:

• Number (of participants) identified through pain clinics, patient organisations memberships
• Number identified via waiting lists at the hospital department of pain medicine
• Number screened for eligibility
• Number eligible following screening
• Reasons for ineligibility
• Number completed consent forms
• Reasons for non-participation following eligibility screening

Retention: The retention rate will be calculated as the proportion of individuals who, after enrolment, completed the pre-intervention outcome measures and post intervention outcome measures.

Attrition: The attrition rate will be calculated by dividing the total number of participants in the beginning of the trial, by the number of participants who did not complete the study for any reason (e.g. withdrawal, lost to follow-up etc). We will calculate both the attrition rate as well as the reasons for intervention drop-outs.

Adherence: Adherence to the intervention schedule will be assessed through recording attendance at all sessions. Reasons for non-attendance will be recorded by facilitators. Participants will be consulted by MOD on a weekly basis to document adherence to the intervention protocol and any other issues raised by participants throughout the intervention period.

Acceptability: Acceptability will be measured using the Technology Acceptance Model (TAM), a widely recognised framework for understanding user adoption and satisfaction with new technologies. TAM focuses on the interplay of several factors that influence individuals' intention to use and actual usage of technology.

Data Analysis:

Although the feasibility study is not powered to detect statistically significant effects, data on patient reported outcomes will be analysed to inform future trials. For example, if measuring the effectiveness of the intervention on pain intensity, the analysis will be as follows:

Pain Intensity and Duration:

• Outcome: Assess changes in pain levels before and after the VR intervention using the Pain Interference Questionnaire.

• Analysis:

  • Descriptive statistics (means, medians, standard deviations) will summarize pain scores at baseline, during, and after the intervention.
  • Paired t-tests or non-parametric equivalents (e.g., Wilcoxon signed-rank test) can be used to assess within-group changes over time.
  • Effect sizes (e.g., Cohen's d) will be calculated to estimate the magnitude of change, helping to inform future sample size calculations for a full trial.

All data will be analyzed using IBM SPSS Statistics v.24.0 for Windows.

Qualitative Data:

We will also collect qualitative data in the form of a process evaluation.

The primary aims of the process evaluation will be to:

1. Understand participant experiences and perceptions of the VR education intervention.
2. Identify barriers and facilitators to engaging with the VR technology and content.
3. Explore participants' views on the acceptability, usability, and overall satisfaction with the VR intervention..

The semi-structured interview schedule questions were mapped from the Technology Acceptance Model (TAM). Data from these interviews will be analysed in accordance with thematic analysis (Braun and Clarke, 2006).

References

Beck, A. T., Ward, C. H., Mendelson, M., Mock, J., & Erbaugh, J. (1961). An inventory for measuring depression. Archives of General Psychiatry, 4(6), 561-571.

Cleeland, C.S., & Ryan, K.M. (1994). Pain assessment: Global use of the Brief Pain Inventory. Annals of the Academy of Medicine, Singapore, 23(2), 129-138.

Ferrer-García, M., Gutiérrez-Maldonado, J., Riva, G. and Wiederhold, B.K., 2016. Virtual reality-based treatments in eating disorders and obesity: A review. Journal of Contemporary Psychotherapy, 46(4), pp.207-221.

Freeman, D., Reeve, S., Robinson, A., Ehlers, A., Clark, D.M., Spanlang, B. and Slater, M., 2017. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychological Medicine, 47(14), pp.2393-2400.

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Ware, J. E., Kosinski, M., & Keller, S. D. (1996). A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220-233.

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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

The data will be analysed and results published within a 5-year time scale. The Scale-Up4Rehab project runs until December 2028, therefore we do not anticipate any data being used after a 5 year period.