Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Severe reading or comprehension difficulties

Severe hearing impairment

Pregnancy

Presence of an active infection

Trial design

Treatments tested in this trial

  • Clinical and Questionnaire-Based Assessment

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators