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Completed NCT07605143

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

Conditions: Fybromyalgia

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: gonzalo arias alvarez

Location: Universidad San Sebastián Concepción Biobio

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.

Eligibility Criteria

Inclusion Criteria * Female participants aged 18 years or older * Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) diagnostic criteria * Ability to understand and follow study procedures * Provision of written informed consent Exclusion Criteria * Pregnancy or breastfeeding * Cancer-related pain * Uncontrolled metabolic disorders * History of vertigo, vestibular disorders, or any condition that could be aggravated by immersive virtual reality exposure * Neurological or musculoskeletal conditions that contraindicated participation in therapeutic exercise

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07605143). StuddyBuddy aggregates publicly available trial information.