Actively Recruiting
Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
Led by Karlstad University · Updated on 2025-05-21
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karlstad University
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multimodal treatment for provoked vulvodynia, a condition causing chronic vulvar pain. The study aims to assess the feasibility and acceptability of this treatment, its effects on pain and psychosexual health, and how patients, clinicians, and healthcare stakeholders perceive the treatment and its implementation. The project uses a mixed-methods design including both effectiveness and qualitative evaluations across multiple healthcare units. The treatment involves about 11 individual sessions over four months, combining physiological and psychosocial approaches to encourage goal-directed behavior change. Sessions are mostly held via digital video meetings, with some in-person visits, and partners may participate in two sessions. Participants are randomized to a 4, 5, or 6 week baseline period before starting treatment, and a follow-up session occurs three months after treatment ends. Repeated assessments, including pain measurements twice a week, are collected throughout the baseline and treatment periods. Participants undergo a gynecological exam and psychological assessment to confirm suitability, then complete questionnaires on pain, physical tension, sexual and relational health, and treatment experience. They may also be interviewed about their treatment and intimacy experiences. Researchers track changes in pain during touch or insertion, sexual function, pelvic floor tension, and psychological symptoms before, during, and up to six months after treatment. Safety and assessment data are collected through digital tools and interviews, with the overall study lasting about 25 weeks per participant.
CONDITIONS
Brief Title
Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female biological sex
- Age between 18 and 40 years
- Diagnosis of provoked vulvodynia
You will not qualify if you...
- Severe psychological issues requiring priority before vulvodynia treatment (e.g., substance abuse, psychosis)
- Currently pregnant
- Childbirth within the last year
- Post-traumatic stress disorder related to sexual trauma
- Insufficient mastery of the Swedish language
- No experience of vaginal sex, as vaginismus might be suspected
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or digital)
Duration - 4 to 6 weeks
Participants undergo a randomized baseline period of 4, 5, or 6 weeks during which they complete self-assessment questionnaires twice a week to measure pain and other key variables.
Twice-weekly self-assessments using the m-Path app
Duration - Approximately 19 weeks
Participants receive approximately 11 treatment sessions consisting of physiological and psychosocial components focused on goal-directed behavioral change. The first five sessions are weekly, and the last six are biweekly. Sessions are conducted via digital video meetings and in-person at the healthcare facilities, with an option to involve a partner in two sessions.
11 treatment sessions (combination of weekly and biweekly visits) plus twice-weekly self-assessments using the m-Path app
Duration - 3 months after treatment ends
Participants complete a follow-up session three months after the end of treatment to assess outcomes and treatment effects.
1 follow-up visit plus web-based self-assessments before and after treatment and at 6 months follow-up
Trial Site Locations
Total: 1 location
1
Karlstad University
Karlstad, Sweden
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here