Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization

Last updated: May 9, 2025
Sponsor: Badalona Serveis Assistencials
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Pain

Chronic Pain

Treatment

REDOCVR Psychoeducational Program

Standard Educational Materials

Clinical Study ID

NCT06964360
24/211-ACps
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (≥18 years) diagnosed with chronic non-cancer pain persisting for at least 3months

  • Assigned to one of the participating primary care centers

  • Presence of central sensitization symptoms, emotional distress, kinesophobia, orinadequate response to prior treatments

  • Capacity to provide informed consent and complete questionnaires

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: REDOCVR Psychoeducational Program
Phase:
Study Start date:
May 06, 2024
Estimated Completion Date:
March 31, 2026

Study Description

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.

Connect with a study center

  • Primary Care Center Apenins-Montigalà

    Badalona, Barcelona 08917
    Spain

    Active - Recruiting

  • Primary Care Center Morera-Pomar

    Badalona, Barcelona
    Spain

    Active - Recruiting

  • Primary Care Progrès-Raval

    Badalona, Barcelona 08912
    Spain

    Active - Recruiting

  • CAP Montgat- Dr Jardi

    Montgat, Barcelona
    Spain

    Active - Recruiting

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