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临床试验/NCT03800199
NCT03800199Unknown不适用

The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia

European University of Lefke1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Combined Index of Severity of Fibromyalgia

研究概览

简要总结

The aim of the investigator's study is to determine the validity and reliability of the Turkish version of the Combined Index of Severity (ICAF) in Turkish patients with Fibromyalgia Syndrome (FMS).

详细描述

The original form of the Combined Index of Severity of Fibromyalgia (ICAF) will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. These translations will send to 7 different health professions who had experience working with FMS patients. The pre-final version will be composed and tested on a group of patients with FMS. If necessary, readjustments will be made, and the final version will be investigated in FMS patients. Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha and test-retest assessments. Re-test assessments will be conducted after one week from first assessment. Content validity was assessed by examining the floor and ceiling effects and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. In addition, the confirmatory factor analysis will be done to evaluate the validity of ICAF. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
  • Feeling Fibromyalgia symptoms last 3 mounts

排除标准

  • Having physical and functional problems with FMS
  • Having a diagnosis of chronic pain other than FMS,
  • Using medicine other than simple analgesics,
  • History of cardiovascular or pulmonary diseases
  • Can not read and write in Turkish language

结局指标

主要结局

Combined Index of Severity of Fibromyalgia

时间窗: Changes from baseline severity at 12 weeks.

Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping.The ICAF score ranges from 0 to 84, with higher values indicating higher severity.

次要结局

未报告次要终点

研究者

发起方
European University of Lefke
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beraat Alptug

Master Physiotherapist/ Principal Investigator

European University of Lefke

研究点 (1)

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