Analysis of the Understanding of the French Version of the Vulvar Pain Assessment Questionnaire (VPAQ-Trad)

March 4, 2025 updated by: Hopital Foch

Analysis of the Understanding of the French Translation of the Vulvar Pain Assessment Questionnaire (VPAQscreen) and Its Supplemental Scales (VPAQdesc, VPAQcope and VPAQpartner).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • France
      • Suresnes, France, 92150
        • Hopital Foch

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Questionnaire
Completion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
understanding question
Time Frame: Day 1
for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Did you understand that question?"
Day 1
understanding answer
Time Frame: Day 1
for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Did you understand the different possible answers?"
Day 1
understanding
Time Frame: Day 1
for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Can you explain what went wrong?"
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

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 (Actual)

May 6, 2024

Primary Completion (Actual)

February 6, 2025

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_0090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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