- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01252576
Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire
June 21, 2011 updated by: Club Italiano Femminile di Urologia
Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cuneo
-
Savigliano, Cuneo, Italy, 12030
- SS Annunziata Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
women from general population whit or without sexual dysfunction
Description
Inclusion Criteria:
- women aged 18-65 years
Exclusion Criteria:
- mental diseases that do not permit to understand questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
women with and without sexual dysfunction
women with and without female sexual dysfunction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test-retest reliability of FSFI italian translation
Time Frame: 15 days
|
Test-retest reliability of professional translation in italian language of female sexual function index test.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maria Teresa Filocamo, MD, Club Italiano Femminile di Urologia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 1, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1-Villari
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sexual Dysfunction
-
Istanbul University - Cerrahpasa (IUC)CompletedSexual Dysfunction | Pregnancy Related | Postpartum Sexual DysfunctionTurkey
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
-
Cairo UniversityCompleted
-
Alza Corporation, DE, USACompletedSexual Dysfunction | Erectile Dysfunction | Ejaculation
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction | Erectile DysfunctionFrance, Poland, United States, Belgium, Mexico, Malaysia, Canada, Taiwan, Korea, Republic of, Russian Federation, Argentina, Australia, United Kingdom
-
Royal Holloway UniversityNational Health Service, United KingdomCompletedSexual Dysfunction | Sexual Assault | Sex DisorderUnited Kingdom
-
Man Clinic for Andrology, Male Infertility and...UnknownSexual Dysfunction | Erectile Dysfunction | Premature EjaculationEgypt
-
University of UtahAcerus Pharmaceuticals CorporationWithdrawnSexual Dysfunction | Erectile DysfunctionUnited States
-
Assiut UniversityNot yet recruitingSexual Dysfunction