Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire
This trial is active, not recruiting.
|Sponsor||Club Italiano Femminile di Urologia|
|Collaborator||Società Italiana di Urologia (SIU)|
|Start date||December 2010|
|End date||June 2011|
|Trial size||300 participants|
|Trial identifier||NCT01252576, 1-Villari|
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.
women with and without female sexual dysfunction
Test-retest reliability of FSFI italian translation
time frame: 15 days
Female participants from 18 years up to 65 years old.
- women aged 18-65 years
- mental diseases that do not permit to understand questionnaire
|Official title||Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)|
|Principal investigator||Maria Teresa Filocamo, MD|
|Description||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.|
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