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