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

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01252576
• Other study ID #: 1-Villari
• Status: Active, not recruiting
• Phase: N/A
• First received: December 1, 2010
• Last updated: June 21, 2011
• Start date: December 2010

Study information

• Verified date: June 2011
• Source: Club Italiano Femminile di Urologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• women aged 18-65 years

Exclusion Criteria:

• mental diseases that do not permit to understand questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sexual Dysfunction

Locations

Country	Name	City	State
Italy	SS Annunziata Hospital	Savigliano	Cuneo

Sponsors (2)

Lead Sponsor	Collaborator
Club Italiano Femminile di Urologia	Società Italiana di Urologia (SIU)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest reliability of FSFI italian translation	Test-retest reliability of professional translation in italian language of female sexual function index test.	15 days	No