Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 4
- 主要终点
- Change in daily dose of chronic pain medications
研究概览
简要总结
This clinical trial evaluates the effectiveness of the REDOCVR program, an interdisciplinary, psychoeducational intervention designed to support deprescribing of chronic pain medications in primary care. REDOCVR integrates group-based education, physical activation, and emotional regulation techniques, enhanced by immersive virtual reality (VR) content that reinforces therapeutic learning and engagement. Rather than functioning as a standalone tool, VR serves as a complementary catalyst within a person-centered, clinician-guided framework. This randomized trial adds a structured medication tapering component and runs in parallel with a complementary pilot study (ClinicalTrials.gov Identifier: NCT06361706), which evaluates the base REDOCVR program without supervised deprescribing. Both protocols are active and jointly contribute to an adaptive, scalable model of chronic pain care in primary care settings. Outcomes include medication use, emotional well-being, anxiety and depression, quality of life, and usability of VR.
详细描述
This study is part of the broader REDOCVR initiative, a scalable chronic pain management program developed and implemented across primary care centers within Badalona Serveis Assistencials (BSA) in Catalonia, Spain. The REDOCVR program was designed in response to the increasing need for non-pharmacological interventions for chronic pain and integrates psychoeducation, physical activation, and emotional regulation techniques. Immersive virtual reality (VR) is incorporated not as a standalone treatment, but as an enhancing tool to increase engagement, support therapeutic learning, and promote self-management.
This randomized controlled trial represents a complementary arm of the REDOCVR implementation strategy. While the original pilot study (ClinicalTrials.gov Identifier: NCT06361706) focuses on feasibility, usability, and acceptability of the base REDOCVR intervention, the current protocol (24/211-ACps) adds a structured, physician-supervised medication tapering component for patients on chronic pain pharmacotherapy. Both protocols are active and interrelated, reflecting a modular, adaptive implementation model across different primary care sites.
Participants are adults with chronic non-cancer pain, referred during routine clinical visits and screened according to standardized eligibility criteria. The intervention group receives the full REDOCVR program, including immersive VR and deprescribing support, while the control group receives standard educational materials and usual care. Primary and secondary outcomes include change in medication use, emotional well-being (WEMWBS-7), anxiety and depression (HADS), central sensitization (CSI), health-related quality of life (EQ-5D-5L), and usability and satisfaction with the VR platform. Data collection occurs at baseline, post-intervention, and follow-up.
The study follows a hybrid type-2 implementation-effectiveness design and is aligned with ethical and regulatory standards, including approval from the CEIm IDIAPJGol. Findings will contribute to the growing evidence base for interdisciplinary, technology-enhanced models of chronic pain care in real-world primary care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not applicable - participants and providers are aware of group assignment due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) diagnosed with chronic non-cancer pain persisting for at least 3 months
- •Assigned to one of the participating primary care centers
- •Presence of central sensitization symptoms, emotional distress, kinesophobia, or inadequate response to prior treatments
- •Capacity to provide informed consent and complete questionnaires
排除标准
- •Acute pain conditions (duration <3 months)
- •Severe psychiatric or cognitive impairment
- •Uncontrolled vertigo, epilepsy, or major visual/auditory impairments
- •Conditions contraindicating use of VR equipment
- •Inability to attend scheduled sessions
研究组 & 干预措施
REDOCVR Psychoeducational Program
Participants receive the full REDOCVR program, a group-based psychoeducational intervention enhanced with immersive virtual reality (VR). The program includes education on pain neuroscience, emotional regulation techniques, physical activation exercises, and VR-based experiential modules. Family physicians provide structured support for supervised tapering of chronic pain medications. The intervention is delivered over 8 weekly sessions of 90 minutes.
干预措施: REDOCVR Psychoeducational Program (Behavioral)
Control - Standard Education
Participants receive standard written and audiovisual educational materials related to chronic pain self-management. No virtual reality or group intervention is provided. Participants continue with usual care and may receive general support from their primary care physician, but without structured deprescribing guidance.
干预措施: Standard Educational Materials (Behavioral)
结局指标
主要结局
Change in daily dose of chronic pain medications
时间窗: Baseline, immediately post-program (8 weeks), 3-month follow-up
Reduction in total daily dosage of prescribed medications used for chronic pain (e.g., opioids, benzodiazepines, NSAIDs), converted into standardized dose equivalents.
次要结局
- Change in emotional well-being measured using the 7-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-7)(Baseline, immediately post-program (8-10 weeks))
- Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS), assessing both anxiety and depression subscales.(Baseline, immediately post-program (8-10 weeks))
- Change in central sensitization symptoms measured using the Central Sensitization Inventory (CSI), a self-report tool for sensitization-related symptoms.(Baseline, immediately post-program (8-10 weeks))
- Change in health-related quality of life measured using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)(Baseline, immediately post-program (8-10 weeks))
研究者
Jose Ferrer Costa
Medical Researcher and Project Manager
Badalona Serveis Assistencials