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

C

Club Italiano Femminile di Urologia

Status

Unknown

Conditions

Sexual Dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT01252576
1-Villari

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • women aged 18-65 years

Exclusion criteria

  • mental diseases that do not permit to understand questionnaire

Trial design

300 participants in 1 patient group

women with and without sexual dysfunction
Description:
women with and without female sexual dysfunction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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