VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study — REDOCVR  

Chronic Pain Clinical Trial

Official title: Desenvolupament i Avaluació de l'Experiència en Realitat Virtual en la Prova Pilot Per a Pacients Amb Dolor Crònic i Sensibilització Central Als Centres d'Atenció Primària de Badalona Serveis Assistencials

Status Recruiting

Clinical Trial Summary

This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes. Key objectives and related measured variables include: Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program. Participant Engagement and Program Adherence: Determined by participants' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates. Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up. Healthcare Professionals' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management. Participants will complete eight 90-minute sessions, engaging with VR to supplement the program's content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined. By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management.

Clinical Trial Description

The REDOCVR study is an innovative initiative to evaluate the adjunctive use of Virtual Reality (VR) within a psychoeducational framework for managing chronic pain and central sensitization. This initiative aims to harness the immersive potential of VR to enhance traditional psychoeducational strategies, thereby providing a more engaging and impactful patient experience. Study Design Overview: The study is structured as a prospective, non-randomized pilot intervention spanning September 2023 to December 2025 across select Primary Care Centers within Badalona Serveis Assistencials. Targeting adults with chronic pain, the intervention seeks to determine the feasibility, usability, and preliminary efficacy of incorporating VR into pain management protocols. Recruitment and Selection Process Initial Information: The Primary Care Team is informed about the study and introduces it to potential participants that they identifiy in their daily clinical work, who are then scheduled for an evaluation through the centers electronic system. Selection Procedure: Interested candidates are contacted via phone for further selection through a face-to-face recruitment visit, assessing eligibility by the Inclusion and Exclusion Criteria and collecting informed consent along with baseline data. Data Collection and Analysis Specifics: Data will be meticulously collected on paper before being digitized for analysis, ensuring a robust process for capturing and analyzing participant responses, feedback, and outcomes. This process underscores the study's commitment to methodological rigor and data integrity. Ethical Considerations: Detailed information on informed consent, data management, privacy, and confidentiality will be addressed in the ethical considerations section. Innovative Intervention Approach: Participants are introduced to VR as a tool for understanding and managing their condition, with sessions designed to align VR experiences with educational content. The program includes 8 weekly sessions, each lasting 90 minutes, with VR experiences embedded into the curriculum to reinforce learning objectives and engage participants in their care process actively. Technological and Methodological Framework: The intervention leverages Oculus Quest 2 headsets, chosen for their standalone capability and immersive quality. Custom content developed using Unity software focuses on mindfulness, pain education, and self-management techniques, ensuring that VR sessions are directly relevant to participants' learning and therapeutic goals. Overview of Sessions The intervention framework consists of 8 weekly, 90-minute sessions conducted in session rooms within healthcare centers. Each session incorporates a dedicated 15-20 minute segment for VR experiences designed to complement the session's theme and objectives. Recruitment Visit A 30-minute recruitment visit initiates the study process, involving eligibility assessment through anamnesis, detailing the study's scope, and gathering informed consent from participants. Session Breakdown 1. Introduction to VR Begins with an overview presented by healthcare professionals, followed by an introduction to VR technology, including a practical demonstration to acquaint patients with VR, capped with a 15-minute mindfulness technique using VR. 2. Pain Neurophysiology and Self-management Techniques Focuses on explaining the neurophysiology of pain and introducing pain self-management techniques, including habit changes. Features an educational video to deepen the acquired knowledge. 3. Psychological Aspects of Pain Concentrates on the psychological dimensions of pain, including the gate control theory. Utilizes 360-degree VR videos, controlled by a psychologist with a tablet, explaining techniques for pain awareness and acceptance. 4 & 6: Reeducation of the Central Nervous System (CNS) Through Physical Activity Engages patients in CNS reeducation activities using interactive VR games designed to encourage physical activity in a fun and engaging manner, overseen by a physiotherapist. 5: Psychological Aspects of Pain - Emotions and Thoughts Addresses emotions and thoughts associated with chronic pain through an educational VR session on emotional management techniques. 7: Emotions and Self-esteem Focuses on acceptance, self-esteem, and emotion management, incorporating a VR educational session on compassionate acceptance techniques. 8: Farewell A closing session that reviews covered content and concludes with a final VR session on attentive breathing techniques for relaxation and skill consolidation. Expected Outcomes and Contributions: Through a detailed exploration of VR's role in psychoeducation for chronic pain, the REDOCVR study aims to provide valuable insights into how digital health innovations can enhance traditional therapeutic modalities. The findings are anticipated to inform future interventions, guide clinical practice, and contribute to the broader dialogue on integrating technology into patient care. ;

Related Conditions & MeSH terms

• Central Sensitization
• Chronic Pain

• NCT number: NCT06361706
• Study type: Interventional
• Source: Badalona Serveis Assistencials
• Contact: Jose Ferrer Costa, MD
• Phone: 0034933951779
• Email: jfcosta@bsa.cat
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Completion date: December 2025