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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01252576
Enrollment
300
Registered
2010-12-03
Start date
2010-12-31
Completion date
Unknown
Last updated
2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction

Keywords

FSFI, female sexual function, italian validation

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.

Interventions

None listed

Sponsors

Società Italiana di Urologia (SIU)
CollaboratorOTHER
Club Italiano Femminile di Urologia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* women aged 18-65 years

Exclusion criteria

* mental diseases that do not permit to understand questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Test-retest reliability of FSFI italian translation15 daysTest-retest reliability of professional translation in italian language of female sexual function index test.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026