VulvodyniaVPAQ-TradNCT06476002
Analysis of the Understanding of the French Version of the Vulvar Pain Assessment Questionnaire
A study testing Questionnaire in people with Vulvodynia, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2024to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with vulvar pain associated with other pathologies
- Deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvodynia
- Being tested
- Questionnaire
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Completion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 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?"
Measured: 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?"
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start6 May 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476002
- Sponsor's protocol ID
- 2023_0090
- Acronym
- VPAQ-Trad
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Understanding of the French Translation of the Vulvar Pain Assessment Questionnaire (VPAQscreen) and Its Supplemental Scales (VPAQdesc, VPAQcope and VPAQpartner).
- ClinicalTrials.gov ID
- NCT06476002
- Acronym / sponsor ID
- VPAQ-Trad / 2023_0090
- Conditions
- Vulvodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with provoked or mixed vestibulodynia | Other | Other: QuestionnaireCompletion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with vulvar pain associated with other pathologies
- Deprived of liberty or under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireCompletion of translated VPAQscreen, VPAQdesc, VPAQcope and VPAQpartner questionnaires by patients, followed by assessment of comprehension of the various items. | Other | women with provoked or mixed vestibulodynia |
Primary outcome
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?"
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?"
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?"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Vulvodynia, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
understanding question (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.