Clinical Trial

Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia

Study acronym: VIR-FM
Completed
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Summary
Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive complaints, and psychoemotional symptoms, leading to functional impairment and reduced quality of life. Although exercise is recommended as a first-line non-pharmacological treatment, maintaining long-term adherence remains a major challenge. Immersive virtual reality (IVR) has emerged as a promising approach to increase motivation and engagement during rehabilitation by integrating therapeutic exercise with interactive virtual environments. This randomized controlled trial evaluated the effects of a six-week exercise program delivered through immersive virtual reality compared with conventional exercise in women with fibromyalgia. Participants were randomly assigned to either an IVR exercise group or a conventional exercise group. Clinical outcomes were assessed at baseline and after the intervention, including fibromyalgia-related impact, global cognitive screening performance, sleep quality, and psychoemotional symptoms. Treatment adherence and user experience were also evaluated to explore their association with clinical outcomes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-19.
Trial Details
NCT Number NCT07605143
Lead Sponsor gonzalo arias alvarez
Conditions Fybromyalgia
Enrollment 36 participants
Start Date 2025-12-15
Primary Completion 2026-02-16 (estimated)
Study Completion 2026-02-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-17