Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

Sponsor
Izmir Democracy University
Study ID
NCT07416097
Status
Not Yet Recruiting

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Conditions

  • Chronic Widespread Pain
  • Fibromyalgia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Clinical and Questionnaire-Based Assessment — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 17, 2026
Start date
Jun 15, 2026
Status verified
Feb 2026
Primary completion
Nov 15, 2026
Completion
Jun 15, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: Fibromyalgia Group
    Patients diagnosed with fibromyalgia
  • Other: Healty Group
    Healthy women without fibromyalgia or other chronic pain conditions.

Primary Outcome Measure

Assessment of Pain Intensity [ Time Frame: Baseline ]

Central Contacts

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