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

NCT07434804 | Not Yet Recruiting DMC

• 2 other identifiers: LS-25-20-FullenNWE0100082 - Scale-Up4Rehab
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain; Chronic Pain; Chronic Pain (Back / Neck); Adults; Virtual Reality; Neuroscience Pain Education

Keywords

Physiotherapy; rehabilitation; Ireland

Outcome Measures

Primary Outcomes (5)

• 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.

  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

• 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).

  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

• 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).

  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 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)

  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

• 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).

  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

Study Arms (2)

Six-Week VR Pain Science Education Program

EXPERIMENTAL

The study will be conducted as a single-arm feasibility study using a pretest-posttest design. A total of 50 participants with chronic pain (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, delivered over six sessions. 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. 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.

Other: 6-Week Virtual reality-delivered pain science education and behavioural pain management program

Optional Focus Groups

OTHER

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. 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. Participants who participate in the 6 week VR programme have the option of participating in the focus group at the end of the 6 weeks.

Other: 6-Week Virtual reality-delivered pain science education and behavioural pain management program

Interventions

6-Week Virtual reality-delivered pain science education and behavioural pain management program OTHER

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).

Optional Focus Groups; Six-Week VR Pain Science Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Interreg: collaborator
• University College Cork: collaborator

Study Sites (1)

School of Public Health, Physiotherapy and Sports Science, University College Dublin

Dublin, D04, Ireland

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brona Fullen, BSc, MSc, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Hinwood, BSc, PhD

CONTACT

+353 1 716 3442; natasha.hinwood@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, UCD School of Public Health Physiotherapy and Sports Science

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.

Locations

IE (1)