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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Club Italiano Femminile di Urologia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Società Italiana di Urologia (SIU)
Information provided by:
Club Italiano Femminile di Urologia
ClinicalTrials.gov Identifier:
NCT01252576
First received: December 1, 2010
Last updated: June 21, 2011
Last verified: June 2011
  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)

Further study details as provided by Club Italiano Femminile di Urologia:

Primary Outcome Measures:
  • 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
Study Population

women from general population whit or without sexual dysfunction

Criteria

Inclusion Criteria:

  • women aged 18-65 years

Exclusion Criteria:

  • mental diseases that do not permit to understand questionnaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252576

Locations
Italy
SS Annunziata Hospital
Savigliano, Cuneo, Italy, 12030
Sponsors and Collaborators
Club Italiano Femminile di Urologia
Società Italiana di Urologia (SIU)
Investigators
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 April 23, 2014