Multimodal treatment for chronic vulvar pain
Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
This study is testing a new treatment plan for women with chronic vulvar pain to see if combining different therapies can help reduce pain and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Karlstad University Academic / other |
| Locations | 1 site (Karlstad) |
| Trial ID | NCT06981611 on ClinicalTrials.gov |
What this trial studies
This project aims to develop and evaluate a multimodal treatment for provoked vulvodynia, focusing on its feasibility, acceptability, and effects on pain and psychosexual health. Participants will undergo 11 treatment sessions over four months, which include individual sessions with various professionals and the option for partner involvement. The treatment combines physiological and psychosocial components, utilizing digital video meetings and in-person sessions. A mixed-methods design will be employed to assess the effectiveness of the treatment across multiple healthcare contexts.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-40 who are experiencing provoked vulvodynia.
Not a fit: Patients with severe psychological issues, ongoing pregnancy, or insufficient mastery of the Swedish language may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce chronic vulvar pain and improve the overall psychosexual health of affected patients.
How similar studies have performed: While multimodal approaches to treating chronic pain have shown promise in other studies, this specific treatment for provoked vulvodynia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Biological sex: Female 18-40 years old Provoked vulvodynia Exclusion Criteria: * Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis) * Ongoing pregnancy * Childbirth within the last year * Post-traumatic stress disorder (PTSD) related to sexual trauma * Insufficient mastery of the Swedish language * No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment
Where this trial is running
Karlstad
- Karlstad University — Karlstad, Sweden (Recruiting)
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.