CompletedNot Applicable

Psychometric Validation of the Portuguese DIVAS-Q in Women With Vulvovaginal Atrophic Symptoms

Portugal300 participantsStarted 2022-10-02

Plain-language summary

To determine the reliability and validity of the Portuguese version of the DIVA questionnaire in Portuguese women. This validation will support its use both in research and in routine clinical practice in this population.

Who can participate

Age range

30 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:To present at least one symptom related to genital atrophy, referring to the external genitalia (vulva or vagina): * dryness * itching * irritation * discomfort on urination or during intercourse * pain on urination or during intercourse * bleeding during intercourse Exclusion Criteria: * pregnancy * active cancer * inability to speak Portuguese * mental or physical condition that prevents providing coherent responses to the questionnaire.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychometric validation of Day to Day Impact of Vaginal Ageing Questionnaire (DIVA) to Portuguese Woman from Portugal Country. The methodological approach is a descriptive cross-sectional study of qualitative and quantitative variables.

Timeframe: Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.

Trial details

NCT IDNCT07250490

SponsorInstituto Politécnico de Leiria

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-22

View on ClinicalTrials.gov More Vulvovaginal Atrophy trials