Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

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.

Conditions

• Fibromyalgia
• Chronic Widespread Pain

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.

Sponsors & Collaborators

• Izmir Democracy University

  lead OTHER

Principal Investigators

• Meltem Sevgili, Pt. · Izmir Democracy University

• Cemre Emir, Msc.Pt.. · Izmir Democracy University

• Onur Engin, asst.prof · Izmir Democracy University

• Kadir Songür, Ast.prof · Izmir Democracy University

• Ferruh Taşpınar, Prof.Dr. · Izmir Democracy University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2026-11-15

Completion

2027-06-15

Countries

• Turkey (Türkiye)

Study Locations