French Translation of The Female Sexual Distress Scale-Revised (f-FSDS-R)

French Translation of the Self-administered Questionnaire The Female Sexual Distress Scale-Revised

Two independent teams (Brest and Nice) each produce a forward translation from English to French. The translations are compared, and discrepancies are discussed with the translation coordinator, the second translator, and the scientific lead to produce a unified preliminary French version (Version 1), including the response options.

Version 1 is then back-translated into English by an English-speaking linguist and a French physician whose native language is English, without access to the original questionnaire, in order to detect potential translation issues. The team then holds a discussion to compare the original English version, the French Version 1, and the back-translations, resulting in the development of Version 2.

Version 2 is tested with a representative sample of patients using a paper questionnaire, which includes two follow-up questions after each item to assess comprehension and identify potential difficulties. The team analyzes the responses, and if comprehension issues are identified, they organize further discussions with the translators and back-translators to revise the items concerned. The revised items are then re-tested with patients, including those who have and have not reported difficulties, to ensure that the final version is clear and understandable for all.

the investigators conduct prospective recruitment after verifying the inclusion and exclusion criteria.

Inclusion criteria:

Adult patient Affiliation with a social security scheme

Exclusion criteria:

Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Patients with difficulties understanding the French language Patients consulting in the adult or gynecological emergency department, or accompanying another person, are informed about the possibility of completing a questionnaire.

The participants informed that their data will be recorded for the purpose of practice evaluation and results analysis in an anonymous and confidential manner, using the information sheet provided for the study. The participants free to refuse participation without any impact on their care.

Patients receive complete and clear information regarding the objectives of the study, their right to refuse participation, and their right to withdraw at any time. All this information appears on the information and non-opposition form provided to each patient. Participation is noted in the patient's medical record.

Administration procedures:

The questionnaire is distributed in the waiting area and is self-administered by the patient. Once consent is given, the patient completes the questionnaire independently.

Follow-up:

The estimated participation time is approximately 10 minutes, corresponding to the time required to complete the questionnaire. Patients may be contacted again if necessary to re-test reformulated items, including those who reported comprehension difficulties and others who did not.

The inclusion period lasts 6 months. The individual participation time is 10 minutes. The total duration of the prospective study (inclusion + follow-up) is 8 months.

The overall study timeline (including data entry and management of non-opposition forms) is 12 months.

Study Overview

• Status: Active, not recruiting
• Conditions: The Translation of a Screening Tool

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Chu Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in gynecology, obstetrics and adult emergencies, as well as those accompanying a third party.

Description

Inclusion Criteria:

• >18 years
• affiliated to a social security scheme

Exclusion Criteria:

• Patients under judicial protection (guardianship, curatorship, ...)
• Refusal to participate
• Patient having difficulties understanding the French language.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is the item-by-item response rate to the paper-based questionnaire, assessing the acceptability and feasibility of the French version of the FSDS-R in the target population.	from March to September 2025

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 29BRC24.0396 - f-FSDS-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No