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NOT YET RECRUITING
NCT07416097
NA

Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

Sponsor: Izmir Democracy University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-06-15

Completion Date

2027-06-15

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

OTHER

Clinical and Questionnaire-Based Assessment

Participants will undergo a non-interventional, cross-sectional assessment including demographic data collection and self-reported questionnaires assessing pain and fatigue (VAS), perceived stress, anxiety and depression (HADS), self-esteem (Rosenberg Self-Esteem Scale), autonomic function (COMPASS-31), sleep quality (Pittsburgh Sleep Quality Index), eating behaviors (Three-Factor Eating Questionnaire), and gastrointestinal symptoms. No therapeutic intervention will be applied.

Locations (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)