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临床试验/NCT07344675
NCT07344675Enrolling By Invitation不适用

Relationship Between Fibromyalgia Syndrome and Chronic Pelvic Pain: A Cross-Sectional Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
128
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

This study aimed to compare patients with and without fibromyalgia syndrome in terms of chronic pelvic pain and pelvic floor dysfunction.

详细描述

The study planned for two patient groups in the Physical Medicine and Rehabilitation outpatient clinic: female patients followed up for fibromyalgia and a control group matched for age and gender without fibromyalgia syndrome. Demographic data, symptom duration, chronic pelvic pain, and pelvic dysfunction symptoms will be assessed in both groups. Pain levels will be measured using the Visual Analog Scale and the McGill Pain Questionnaire Short Form. Additionally, the Fibromyalgia Impact Questionnaire, the Chronic Pelvic Pain Impact Questionnaire, and the Short Form-12 for quality of life assessment will be completed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participants aged 18 and over
  • Voluntary participation in the study

排除标准

  • Individuals with cognitive impairment
  • History of pelvic surgery within the last 3 months
  • Severe cardiac, renal, liver disease, respiratory or endocrine dysfunction, uncontrolled psychiatric illness
  • Pregnant or breastfeeding women
  • Individuals with neuropathy or central nervous system disorders
  • History of neoplasm in the pelvic region

结局指标

主要结局

Visual Analog Scale

时间窗: Day 1

The score is obtained by measuring, with a ruler, the distance in millimeters along the 10-cm line from the "no pain" reference point to the mark indicated by the patient, yielding a total score between 0 and 100, where higher values reflect increased pain severity.

Short-Form McGill Pain Questionnaire

时间窗: Day 1

The Short-Form McGill Pain Questionnaire was developed as a condensed version of the original instrument. Its core section includes 15 pain descriptors, consisting of 11 sensory and 4 affective items, each rated according to intensity on a 4-point scale from 0 (no pain) to 3 (severe pain).

Pelvic Pain Impact Questionnaire

时间窗: Day 1

The self-administered Pelvic Pain Impact Questionnaire assesses the effect of pelvic pain on daily life. It comprises 8 mandatory and 2 optional items, each rated on a 5-point Likert scale, yielding a total score from 0 to 32, with higher scores indicating greater impact on daily functioning.

次要结局

  • Fibromyalgia Impact Questionnaire(Day 1)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Çiftci

Medical doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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