FibromyalgiaNCT07416097
Comparison of Multidimensional Parameters in Women With Fibromyalgia and Healthy Controls
A study testing Clinical and Questionnaire-Based Assessment in people with Fibromyalgia and Chronic Widespread Pain, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Widespread Pain
- What is being tested?
- Clinical and Questionnaire-Based Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Symptoms, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, and Gastrointestinal Parameters in Women With Fibromyalgia and Healthy Women: A Cross-Sectional Study
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.
Read the detailed description
Fibromyalgia (FM) is a chronic and widespread pain syndrome affecting the musculoskeletal system. It affects approximately 2%-6.6% of the world population and is the second most common rheumatic disease worldwide. Fibromyalgia is a syndrome that seriously and negatively affects individuals' lives. Patients commonly experience pain, fatigue, sleep problems, morning stiffness, psychological problems, and impairments in cognitive functions. These symptoms lead to physical disabilities, decreased physical activity, and difficulties in career and social life. In this syndrome, symptoms may periodically remit, while at other times exacerbations may occur.
The pathophysiology of FM has not yet been clearly defined. Increased sensitivity of nociceptive neurons to normal or subthreshold afferent inputs, referred to as central sensitization, is thought to particularly explain the condition of individuals with FM. The uncertainty of fibromyalgia etiology, the wide variety of symptoms, and the individualized way in which it affects each person indicate that a multidimensional assessment is required.
Fibromyalgia is a complex syndrome that seriously and negatively affects not only pain and physical functions but also psychological status, sleep quality, autonomic functions, self-esteem, eating behaviors, and gastrointestinal symptoms. Depression and anxiety are among the most common problems in individuals with FM. In one study, while the prevalence of depression was approximately 39% and anxiety approximately 40% in individuals with chronic pain, these rates were reported as 54% for depression and 55% for anxiety in fibromyalgia. As the levels of depression and anxiety increase, individuals' functional status, symptoms, and quality of life are adversely affected (5). This demonstrates that treatment should not focus solely on physical aspects and pain, but that psychosocial conditions should also be addressed using a holistic approach.
Fibromyalgia is also associated with autonomic nervous system dysfunctions. Studies have shown that sympathetic nervous system activity is increased at rest in individuals with FM, while the stress response is diminished. In particular, orthostatic intolerance, tachycardia, gastrointestinal dysfunction, sweating disorders, and urinary symptoms have a higher prevalence in patients compared to healthy groups. In addition, these autonomic symptoms have been shown to be associated with pain severity, fatigue, and quality of life. These findings suggest that autonomic dysfunction is an important component of FM and that autonomic regulation strategies should be considered in symptom management.
Sleep problems are among the most common accompanying issues. Difficulties in falling asleep, sleep duration, sleep depth, sleep continuity, and sleep architecture disturbances are observed in 70-90% of patients. Excessive fatigue upon awakening in the morning is also common. Numerous studies have demonstrated the relationship between poor sleep quality and pain, fatigue, functional capacity, psychological status, and quality of life in fibromyalgia.
Self-esteem refers to an individual's balanced perspective toward themselves. It is a self-concept influenced by underlying disorders and their consequences, as well as by social support. Persistent pain, fatigue, functional limitations, decreased activities of daily living, and reduced quality of life experienced by individuals with FM significantly affect self-esteem, and this has been supported by various studies. Since self-esteem is associated with depression and anxiety in individuals with FM, it is considered one of the core components of the disease.
Eating behaviors are also affected in individuals with FM. Studies have shown that the prevalence of emotional, external, and restrained eating behaviors is higher in individuals with FM compared to healthy individuals and that these behaviors are associated with pain, depression, and anxiety. Eating behaviors are closely linked to the psychosocial components of FM and therefore require evaluation. However, there are a limited number of studies in the literature examining eating behaviors and eating disorders in individuals with FM.
Gastrointestinal (GI) symptoms are among the problems that significantly contribute to the multidimensional clinical presentation of the disease and are frequently encountered in individuals with FM. Complaints such as irritable bowel syndrome (IBS), abdominal pain, bloating, constipation, and diarrhea are commonly observed. These symptoms are thought to be associated with increased central sensitivity, visceral hypersensitivity, and gut microbiota imbalances seen in individuals with FM, and may exacerbate pain severity, fatigue, sleep disturbances, stress, and anxiety.
Fibromyalgia is a multifaceted syndrome in which physiological, psychological, and social components are affected together. Therefore, it is important to evaluate not only pain and physical symptoms but also psychological status, autonomic symptoms, sleep, self-esteem, eating behaviors, and gastrointestinal complaints collectively. The World Health Organization's definition of health as a state of physical, mental, and social well-being supports the need to address FM with a holistic approach. In this context, it is anticipated that our study will contribute to the literature by evaluating fibromyalgia from a multidisciplinary perspective. Therefore, the aim of our study is 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
- Being tested
- Clinical and Questionnaire-Based Assessment
- Keywords
- Fibromyalgia, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, Gastrointestinal Parameters
- Medical subject headings
- Fibromyalgia, Chronic Pain, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Questionnaire-Based AssessmentOther
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 group | Role | What they receive |
|---|---|---|
| Fibromyalgia Group | Other | Patients diagnosed with fibromyalgia Receives: Other: Clinical and Questionnaire-Based Assessment |
| Healty Group | Other | Healthy women without fibromyalgia or other chronic pain conditions. Receives: Other: Clinical and Questionnaire-Based Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Meltem Sevgili, Pt., Principal investigator, Izmir Democracy UniversityCemre Emir, Msc.Pt.., Principal investigator, Izmir Democracy UniversityOnur Engin, asst.prof, Principal investigator, Izmir Democracy UniversityKadir Songür, Ast.prof, Principal investigator, Izmir Democracy UniversityFerruh Taşpınar, Prof.Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416097
- Sponsor's protocol ID
- Compass-35
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Symptoms, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, and Gastrointestinal Parameters in Women With Fibromyalgia and Healthy Women: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07416097
- Acronym / sponsor ID
- Compass-35
- Conditions
- Fibromyalgia, Chronic Widespread Pain
- Keywords
- Fibromyalgia, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, Gastrointestinal Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia (FM) is a chronic and widespread pain syndrome affecting the musculoskeletal system. It affects approximately 2%-6.6% of the world population and is the second most common rheumatic disease worldwide. Fibromyalgia is a syndrome that seriously and negatively affects individuals' lives. Patients commonly experience pain, fatigue, sleep problems, morning stiffness, psychological problems, and impairments in cognitive functions. These symptoms lead to physical disabilities, decreased physical activity, and difficulties in career and social life. In this syndrome, symptoms may periodically remit, while at other times exacerbations may occur.
The pathophysiology of FM has not yet been clearly defined. Increased sensitivity of nociceptive neurons to normal or subthreshold afferent inputs, referred to as central sensitization, is thought to particularly explain the condition of individuals with FM. The uncertainty of fibromyalgia etiology, the wide variety of symptoms, and the individualized way in which it affects each person indicate that a multidimensional assessment is required.
Fibromyalgia is a complex syndrome that seriously and negatively affects not only pain and physical functions but also psychological status, sleep quality, autonomic functions, self-esteem, eating behaviors, and gastrointestinal symptoms. Depression and anxiety are among the most common problems in individuals with FM. In one study, while the prevalence of depression was approximately 39% and anxiety approximately 40% in individuals with chronic pain, these rates were reported as 54% for depression and 55% for anxiety in fibromyalgia. As the levels of depression and anxiety increase, individuals' functional status, symptoms, and quality of life are adversely affected (5). This demonstrates that treatment should not focus solely on physical aspects and pain, but that psychosocial conditions should also be addressed using a holistic approach.
Fibromyalgia is also associated with autonomic nervous system dysfunctions. Studies have shown that sympathetic nervous system activity is increased at rest in individuals with FM, while the stress response is diminished. In particular, orthostatic intolerance, tachycardia, gastrointestinal dysfunction, sweating disorders, and urinary symptoms have a higher prevalence in patients compared to healthy groups. In addition, these autonomic symptoms have been shown to be associated with pain severity, fatigue, and quality of life. These findings suggest that autonomic dysfunction is an important component of FM and that autonomic regulation strategies should be considered in symptom management.
Sleep problems are among the most common accompanying issues. Difficulties in falling asleep, sleep duration, sleep depth, sleep continuity, and sleep architecture disturbances are observed in 70-90% of patients. Excessive fatigue upon awakening in the morning is also common. Numerous studies have demonstrated the relationship between poor sleep quality and pain, fatigue, functional capacity, psychological status, and quality of life in fibromyalgia.
Self-esteem refers to an individual's balanced perspective toward themselves. It is a self-concept influenced by underlying disorders and their consequences, as well as by social support. Persistent pain, fatigue, functional limitations, decreased activities of daily living, and reduced quality of life experienced by individuals with FM significantly affect self-esteem, and this has been supported by various studies. Since self-esteem is associated with depression and anxiety in individuals with FM, it is considered one of the core components of the disease.
Eating behaviors are also affected in individuals with FM. Studies have shown that the prevalence of emotional, external, and restrained eating behaviors is higher in individuals with FM compared to healthy individuals and that these behaviors are associated with pain, depression, and anxiety. Eating behaviors are closely linked to the psychosocial components of FM and therefore require evaluation. However, there are a limited number of studies in the literature examining eating behaviors and eating disorders in individuals with FM.
Gastrointestinal (GI) symptoms are among the problems that significantly contribute to the multidimensional clinical presentation of the disease and are frequently encountered in individuals with FM. Complaints such as irritable bowel syndrome (IBS), abdominal pain, bloating, constipation, and diarrhea are commonly observed. These symptoms are thought to be associated with increased central sensitivity, visceral hypersensitivity, and gut microbiota imbalances seen in individuals with FM, and may exacerbate pain severity, fatigue, sleep disturbances, stress, and anxiety.
Fibromyalgia is a multifaceted syndrome in which physiological, psychological, and social components are affected together. Therefore, it is important to evaluate not only pain and physical symptoms but also psychological status, autonomic symptoms, sleep, self-esteem, eating behaviors, and gastrointestinal complaints collectively. The World Health Organization's definition of health as a state of physical, mental, and social well-being supports the need to address FM with a holistic approach. In this context, it is anticipated that our study will contribute to the literature by evaluating fibromyalgia from a multidisciplinary perspective. Therefore, the aim of our study is to compare symptoms, psychological status, autonomic function, sleep, eating behaviors, and gastrointestinal parameters between women with fibromyalgia and healthy women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Group | Other | Other: Clinical and Questionnaire-Based AssessmentPatients diagnosed with fibromyalgia |
| Healty Group | Other | Other: Clinical and Questionnaire-Based AssessmentHealthy women without fibromyalgia or other chronic pain conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Severe reading or comprehension difficulties
- Severe hearing impairment
- Pregnancy
- Presence of an active infection
- Neurological or orthopedic conditions that limit mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Questionnaire-Based AssessmentParticipants 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. | Other | Fibromyalgia Group, Healty Group |
Primary outcome
Assessment of Pain Intensity
Time frame: Baseline
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.
Assessment of Fatigue
Time frame: Baseline
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.
Perceived Stress Scale-10 (PSS-10)
Time frame: Baseline
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
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.
Rosenberg Self-Esteem Scale (RSES)
Time frame: Baseline
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.
COMPASS-31 Autonomic Symptom Questionnaire
Time frame: Baseline
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
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.
Three-Factor Eating Questionnaire (TFEQ-18)
Time frame: Baseline
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.
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meltem Sevgili, Pt. principal investigator
Izmir Democracy University
Cemre Emir, Msc.Pt.. principal investigator
Izmir Democracy University
Onur Engin, asst.prof principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and Questionnaire-Based Assessment in people with Fibromyalgia and Chronic Widespread Pain, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Taşpınar, Prof.Dr. (+90 506 680 44 26, betul.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain Intensity (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.