Comparison of Symptoms, Psychological Status, Autonomic Function, Sleep, Eating Behaviors, and Gastrointestinal Parameters in Women With Fibromyalgia and Healthy Women: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fibromyalgia Group
Patients diagnosed with fibromyalgia
干预措施: Clinical and Questionnaire-Based Assessment (Other)
Healty Group
Healthy women without fibromyalgia or other chronic pain conditions.
干预措施: Clinical and Questionnaire-Based Assessment (Other)
结局指标
主要结局
Assessment of Pain Intensity
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Betül Taşpınar
Prof.Dr.
Izmir Democracy University