RecruitingNot ApplicableNCT06964360

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

Sponsor

Badalona Serveis Assistencials

Enrollment

72 participants

Start Date

May 6, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Central Sensitisation Opioid-Related Disorders Patient Empowerment

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria5

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

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Interventions

BEHAVIORALREDOCVR Psychoeducational Program

A clinician-guided, group-based psychoeducational program combining pain neuroscience education, emotional regulation techniques, physical activation, and immersive virtual reality experiences. Delivered in eight weekly 90-minute sessions. Includes structured medication tapering support provided by primary care physicians.

BEHAVIORALStandard Educational Materials

Participants receive written and audiovisual materials on chronic pain self-management. Materials are used independently without group sessions or virtual reality. No structured tapering support is provided beyond usual care.