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Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

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  • Are you between 18 and 65 years old?

Source: NCT07416097, who can take part

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Trial details

Who runs it
Izmir Democracy University
Trial code
NCT07416097
Record updated
17 February 2026
Original description
Fibromyalgia (FM) is a chronic, widespread pain syndrome affecting 2-6.6% of the population and significantly impairing quality of life. In addition to pain, individuals with FM commonly experience fatigue, sleep disturbances, cognitive and psychological problems, leading to functional limitations and social difficulties. Central sensitization is considered a key mechanism, although the exact pathophysiology remains unclear, highlighting the need for multidimensional assessment.Read full original descriptionShow less

Comparison of Symptoms, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, and Gastrointestinal Parameters in Women With Fibromyalgia and Healthy Women: A Cross-Sectional Study

Fibromyalgia (FM) is a chronic, widespread pain syndrome affecting 2-6.6% of the population and significantly impairing quality of life. In addition to pain, individuals with FM commonly experience fatigue, sleep disturbances, cognitive and psychological problems, leading to functional limitations and social difficulties. Central sensitization is considered a key mechanism, although the exact pathophysiology remains unclear, highlighting the need for multidimensional assessment.

FM affects not only physical function but also psychological status, autonomic nervous system regulation, sleep quality, self-esteem, eating behaviors, and gastrointestinal function. Depression, anxiety, autonomic dysfunction, sleep disorders, altered eating behaviors, and gastrointestinal symptoms are highly prevalent and closely associated with pain severity, fatigue, and reduced quality of life.

Given its complex biopsychosocial nature, FM requires a holistic evaluation and management approach. Accordingly, this study aims to compare symptoms, psychological status, autonomic function, sleep, eating behaviors, and gastrointestinal parameters between women with fibromyalgia and healthy women.

Inclusion: Fibromyalgia Group; Female participants aged between 18 and 65 years; Admitted to the Physical Medicine and Rehabilitation Unit of Buca Seyfi Demirsoy Training and Research Hospital; Voluntary participation and provision of written informed consent; Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria; Healthy Control Group; Female participants aged between 18 and 65 years; Admitted to the Physical Medicine and Rehabilitation Unit of Buca Seyfi Demirsoy Training and Research Hospital; Voluntary participation and provision of written informed consent; No history or current diagnosis of chronic widespread pain, fibromyalgia, or any rheumatologic disease.

Exclusion: Severe hearing impairment; Presence of an active infection; Neurological or orthopedic conditions that limit mobility; Diagnosis of cancer; History of major surgery within the past 6 months; Presence of psychiatric or cognitive disorders that may interfere with study assessments; Severe reading or comprehension difficulties; Pregnancy.

ClinicalTrials.gov NCT07416097