Treatment for pain during intercourse using somatocognitive therapy
Effectiveness and Cost-utility of Somatocognitive Therapy Versus Treatment as Usual for Provoked (Localized) Vestibulodynia - a Randomized Clinical Trial (ProLoVe Study)
NA · Oslo Metropolitan University · NCT04613713
This study is testing a new therapy called somatocognitive therapy to see if it can help young women with pain during intercourse feel better compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Oslo Metropolitan University (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04613713 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of somatocognitive therapy (SCT) compared to standard treatment for women suffering from provoked vestibulodynia (PVD), a common pain condition affecting sexual intercourse. The study will involve 128 women aged 18 to 35 who will be randomly assigned to receive either SCT or treatment as usual after a baseline assessment. The trial aims to assess not only the clinical effectiveness of SCT but also its cost-effectiveness and identify factors that may influence treatment outcomes. Participants will be recruited from a single center in Oslo, Norway, and will undergo a thorough eligibility evaluation before enrollment.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 35 with a clinical diagnosis of provoked vestibulodynia.
Not a fit: Patients with active infections or dermatologic lesions in the vulvar region, or those with psychiatric conditions requiring specialized treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, effective treatment option for women suffering from provoked vestibulodynia.
How similar studies have performed: While somatocognitive therapy has been previously evaluated for chronic pelvic pain, this specific application for provoked vestibulodynia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of provoked vestibulodynia * Age: 18 to 35 * Must understand Norwegian well enough to be able to complete questionnaires * Must be able to attend treatment in Oslo, Norway Exclusion Criteria: * Active infection in the vulvar region * Dermatologic lesion in the vulvar region * Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology
Where this trial is running
Oslo
- Oslo Metropolitan University — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Slawomir Wojniusz, Phd — Oslo Metropolitan University
- Study coordinator: Slawomir Wojniusz, Phd
- Email: slawomir@oslomet.no
- Phone: +47 419 26 564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vulvodynia, Vestibulodynia, Provoked vestibulodynia, Dyspareunia, Somatocognitive therapy, Physiotherapy, Randomised clinical trial, Women's health