Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Sexual Dysfunction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI) |
- Test-retest reliability of FSFI italian translation [ Time Frame: 15 days ] [ Designated as safety issue: No ]Test-retest reliability of professional translation in italian language of female sexual function index test.
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2010 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
women with and without sexual dysfunction
women with and without female sexual dysfunction
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
women from general population whit or without sexual dysfunction
Inclusion Criteria:
- women aged 18-65 years
Exclusion Criteria:
- mental diseases that do not permit to understand questionnaire
Contacts and Locations| Italy | |
| SS Annunziata Hospital | |
| Savigliano, Cuneo, Italy, 12030 | |
| Principal Investigator: | Maria Teresa Filocamo, MD | Club Italiano Femminile di Urologia |
More Information
No publications provided
| Responsible Party: | D.ssa Donata Villari, CIFU |
| ClinicalTrials.gov Identifier: | NCT01252576 History of Changes |
| Other Study ID Numbers: | 1-Villari |
| Study First Received: | December 1, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Club Italiano Femminile di Urologia:
|
FSFI female sexual function italian validation |
Additional relevant MeSH terms:
|
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013