Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls
Not yet recruitingNot applicableNCT07416097
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Comparison of Symptoms, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, and Gastrointestinal Parameters in Women With Fibromyalgia and Healthy Women: A Cross-Sectional Study
- Conditions
- Interventions
- Other: Clinical and Questionnaire-Based Assessment
- Sponsor
- Izmir Democracy University
- Start date
- 2026-06-15
- Primary completion
- 2026-11-15
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria 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 Criteria: * Severe reading or comprehension difficulties * Severe hearing impairment * Pregnancy * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07416097