Analysis of the Understanding of the French Version of the Vulvar Pain Assessment Questionnaire

NCT ID: NCT06476002

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2025-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prior to the current study, a translation into french of the screening version of the VPAQ (VPAQscreen) and its supplemental scales (VPAQdesc, VPAQcope, VPAQpartner) was performed according to the recommended process. The present study aims to evaluate the understanding of this translation on a panel of 30 women suffering from provoked or mixed vestibulodynia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Vulvar Pain Assessment Questionnaire (VPAQ) is a self-assessment questionnaire for chronic vulvar pain. The English-language version has been validated on patients suffering from chronic pain of various causes, mainly vulvodynia. It explores the biopsychosocial dimensions of chronic vulvar pain: description, intensity, temporality, associated symptoms, emotional and cognitive functioning, coping strategies and interpersonal relations with the partner. The VPAQ inventory is divided into a main questionnaire (VPAQfull or a shorter version, VPAQscreen) and 3 supplementary questionnaires exploring Pain Descriptors (VPAQdesc), coping strategies (VPAQcope) and partner factors (VPAQ partner). The VPAQ inventory can be used both for research purposes and clinical practice. Indeed, it helps the patients to better express their symptoms and the providers to cover with one tool all the dimensions of chronic vulvar pain. A french translation would make the VPAQ inventory available for french speaking health care professionals and patients.

The aim of our study is to validate a french translation of the VPAQscreen and its three supplementary questionnaires. Prior to this study, a french translation of these questionnaires was performed according to the recommended process.

Whereas the English VPAQ inventory has been validated on patients with chronic vulvar pain, whatever the cause, the investigators have chosen to carry out this validation on a homogeneous population of women suffering from provoked or mixed vestibulodynia (i.e, pain located on the vulvar vestibule, triggered by local contacts and associated or not with spontaneous pain). Indeed, provoked vestibulodynia is the most frequent and the best-defined clinical subset of vulvodynia (i.e, chronic vulvar pain with no identifiable cause). The investigators excluded patients suffering from vulvodynia involving other sites than the vestibule as well as chronic vulvar pain related to specific causes (neurological, myofascial, etc..) The understanding of this french translation of the VPAQ will be tested on a panel of 30 patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vulvodynia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

women with provoked or mixed vestibulodynia

Completion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items.

Group Type OTHER

Questionnaire

Intervention Type OTHER

Completion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Completion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients over 18 years of age
* with a diagnosis of provoked or mixed vestibulodynia confirmed by an expert gynecologist or vulvar dermatologist
* Have signed a consent form
* French mother tongue and able to read
* Affiliated to a social security scheme

Exclusion Criteria

* Patient with vulvar pain associated with other pathologies
* Deprived of liberty or under guardianship.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Foch

Suresnes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023_0090

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.