Clinical trial NCT01252576: Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire
Official title: Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Dysfunction
Keywords: FSFI
female sexual function
italian validation
Lead sponsor: Club Italiano Femminile di Urologia
Sponsor class: OTHER
Collaborators: name: Società Italiana di Urologia (SIU)
First posted: 2010-12-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women from general population whit or without sexual dysfunction

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* women aged 18-65 years

Exclusion Criteria:

* mental diseases that do not permit to understand questionnaire

Primary outcomes:
measure: Test-retest reliability of FSFI italian translation
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Savigliano
country: Italy
facility: SS Annunziata Hospital
state: Cuneo
Study officials:
affiliation: Club Italiano Femminile di Urologia
name: Maria Teresa Filocamo, MD
role: PRINCIPAL_INVESTIGATOR
References: