NCT06476002

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

June 11, 2024

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • understanding question

    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

    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

    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

Study Arms (1)

women with provoked or mixed vestibulodynia

OTHER

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

Other: Questionnaire

Interventions

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

women with provoked or mixed vestibulodynia

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with vulvar pain associated with other pathologies
  • Deprived of liberty or under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 26, 2024

Study Start

May 6, 2024

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations