Health TrialsbyHealthPanel

Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

ConditionsFibromyalgiaChronic Widespread Pain
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Clinical and Questionnaire-Based Assessment

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Fibromyalgia GroupOther 1 intervention
Group B: Healty GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of Pain Intensity

Pain intensity will be assessed using the Visual Analog Scale (VAS), a simple and widely used self-report measure. Participants will be asked to mark their perceived pain intensity on a 10-cm horizontal line, where 0 represents "no pain" and 10 represents "unbearable pain." Pain severity will be categorized as mild (\<3), moderate (3-6), or severe (\>6). Pain will be evaluated in four different conditions: daytime pain, nighttime pain, pain at rest, and pain during activity.

Time frame
Baseline
2

Assessment of Fatigue

Fatigue severity will be assessed using the Visual Analog Scale (VAS), which is a simple and widely used self-report measure. Participants will be asked to indicate their perceived level of fatigue on a horizontal line, where 0 represents "no fatigue" and 10 represents "extreme fatigue." The fatigue score will be determined by measuring the distance from the beginning of the line to the point marked by the participant using a ruler, and the value will be recorded.

Time frame
Baseline
3

Perceived Stress Scale-10 (PSS-10)

The Perceived Stress Scale-10 (PSS-10) is a self-report questionnaire consisting of 10 items designed to assess the degree to which individuals perceive situations in their lives as stressful and to measure subjective stress perception. Participants rate each item on a 5-point Likert scale ranging from "Never (0)" to "Very often (4)." In this study, the 10-item version of the scale will be used. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

Time frame
Baseline
4

Hospital Anxiety and Depression Scale (HADS)

The Hospital Anxiety and Depression Scale (HADS) is used to assess anxiety and depression in individuals with physical illnesses. It consists of 14 items, with 7 items assessing anxiety and 7 items assessing depression. Odd-numbered items evaluate anxiety symptoms, while even-numbered items evaluate depressive symptoms. Each item is scored on a scale ranging from 0 to 3. Higher scores indicate greater levels of anxiety and depression.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Democracy University

Lead sponsor

Source ClinicalTrials.gov

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