Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls

NCT07416097 | Not Yet Recruiting

• 1 other identifier: Compass-35
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Psychological Status; Autonomic Function; Sleep; Eating Behaviors; Gastrointestinal Parameters

Outcome Measures

Primary Outcomes (9)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• Rosenberg Self-Esteem Scale (RSES)

  The Rosenberg Self-Esteem Scale is a 10-item questionnaire developed to assess global self-worth. Five items are positively worded (items 1, 2, 4, 6, and 7), and five items are negatively worded (items 3, 5, 8, 9, and 10). Items are rated on a 4-point Likert scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). Total scores range from 10 to 40, with higher scores indicating lower self-esteem and lower scores indicating higher self-esteem.

  Baseline

• COMPASS-31 Autonomic Symptom Questionnaire

  The COMPASS-31 is a 31-item self-administered questionnaire designed to assess symptoms of autonomic dysfunction across six domains: orthostatic intolerance, vasomotor dysfunction, secretomotor dysfunction, gastrointestinal dysfunction, bladder dysfunction, and pupillomotor dysfunction. Responses are weighted according to symptom frequency, severity, and impact. Total scores range from 0 to 100, with higher scores indicating more severe autonomic dysfunction.

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 24 items that assesses sleep quality and sleep disturbances. The first 19 items are completed by the participant, while the remaining 5 items are intended for completion by a bed partner or roommate and are not included in the total score. The PSQI evaluates multiple aspects of sleep, including sleep duration, sleep latency, frequency and severity of sleep-related problems, and daytime dysfunction. It comprises seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3 using a specific scoring method. The total score ranges from 0 to 21, with scores of 5 or higher indicating poor sleep quality.

  Baseline

• Three-Factor Eating Questionnaire (TFEQ-18)

  The Three-Factor Eating Questionnaire consists of 18 items and assesses three dimensions of eating behavior: uncontrolled eating, emotional eating, and cognitive restraint. Uncontrolled eating is assessed by items 1, 3, 5, 6, 7, 8, 10, 13, and 17. Emotional eating is measured by items 4, 9, and 14, while cognitive restraint is assessed by items 2, 11, 12, 15, 16, and 18. Higher scores in each subscale indicate a higher level of the corresponding eating behavior.

  Baseline

• Gastrointestinal Symptom Rating Scale (GSRS)

  The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire that evaluates gastrointestinal symptoms across five domains: abdominal pain, reflux, diarrhea, indigestion, and constipation. Items are rated on a Likert-type scale ranging from "no discomfort" to "very severe discomfort." Abdominal pain is assessed by items 1, 4, and 5; reflux by items 2 and 3; diarrhea by items 11, 12, and 14; indigestion by items 6, 7, 8, and 9; and constipation by items 10, 13, and 15. Higher scores indicate greater severity of gastrointestinal symptoms.

  Baseline

Study Arms (2)

Fibromyalgia Group

OTHER

Patients diagnosed with fibromyalgia

Other: Clinical and Questionnaire-Based Assessment

Healty Group

OTHER

Healthy women without fibromyalgia or other chronic pain conditions.

Other: Clinical and Questionnaire-Based Assessment

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.

Fibromyalgia Group; Healty Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia Group
• 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
• Healthy Control Group
• 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
• No history or current diagnosis of chronic widespread pain, fibromyalgia, or any rheumatologic disease

You may not qualify if:

• Severe reading or comprehension difficulties
• Severe hearing impairment
• Pregnancy
• Presence of an active infection
• Neurological or orthopedic conditions that limit mobility
• Diagnosis of cancer
• History of major surgery within the past 6 months
• Presence of psychiatric or cognitive disorders that may interfere with study assessments

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Feeding Behavior

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Meltem Sevgili, Pt.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Cemre Emir, Msc.Pt..

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Onur Engin, asst.prof

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Kadir Songür, Ast.prof

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Ferruh Taşpınar, Prof.Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Taşpınar, Prof.Dr.

CONTACT

+90 506 680 44 26; betul.taspinar@idu.edu.tr

Beyzanur Beğenen Şavlı, Msc.Pt.

CONTACT

+90 539 681 20 42; beyzanurbegenen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (1)