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临床试验/NCT01252576
NCT01252576Unknown不适用

Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)

Club Italiano Femminile di Urologia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Test-retest reliability of FSFI italian translation

研究概览

简要总结

300 italian women will be enroll for linguistic and cultural validation in italian of Female sexual function index (FSFI). This questionnaire is used in most countries to investigate female sexual function. To date there are not validate questionnaires in italian on female sexual function. We decided to start the validation process to give a validated tool to italian investigators.

详细描述

A linguistic translation from the original language into the target language (Italian) will be carried out in parallel by two independent, native Italian-speaking professional translators, with English as their first foreign language. A first consensus meeting, which will involve the two translators and the research group, to compare the Italian versions and yielded a first-consensus Italian version of the scale. After this first phase the study will conduct in multiple Italian centres located in Northern, Central and Southern Italy. At each centre, the FSFI will administer to a female population of subjects with and without sexual dysfunction. Women will be administer the questionnaire at baseline and 2 weeks later, so as to evaluate the test-retest reliability. The patients will ask whether encountered any difficulty (ease of completion, comprehension, problems, etc). The number of patients who will encounter problems in correctly understanding questions and precoded answers will be recorded and discussed. Will also ask the women to indicate the way to ameliorate the test, and, if possible, the changes will be performed. A back-translation of the Italian consensus version will be carried out by a native American English-speaking professional translator, with Italian as her first foreign language, to control the adherence of translation with the original one. The final Italian version of the FSFI will be obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • women aged 18-65 years

排除标准

  • mental diseases that do not permit to understand questionnaire

结局指标

主要结局

Test-retest reliability of FSFI italian translation

时间窗: 15 days

Test-retest reliability of professional translation in italian language of female sexual function index test.

次要结局

未报告次要终点

研究者

发起方
Club Italiano Femminile di Urologia
申办方类型
Other

研究点 (1)

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