Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions: 1. What is the feasibility and acceptability of this multimodal treatment protocol? 2. What are the effects on pain and psychosexual health? 3. How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation? Participants will be recruited through their health care unit and receive a multimodal treatment. The treatment consists of individual sessions with different professionals, in total 11 sessions over a time period of four months. It is possible to involve partners in the treatment during two of the treatment sessions. The majority of the sessions are digital video meetings but some are conducted at the health care unit. The treatment are based on physiological and psychosocial components that have previously shown positive effects for individuals with vulvodynia, and includes both educational and practical elements. The participants will: * Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition * Undergo a multimodal treatment * Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment * Be asked to participate in an interview about their experience of the treatment and intimacy

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Biological sex: Female 18-40 years old Provoked vulvodynia

Locations
Other Locations
Sweden
Karlstad University
RECRUITING
Karlstad
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia
A multimodal treatment consisting of approximately 11 treatment sessions, for provoked vulvodynia. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, via digital video meetings and meetings at the health care facilities. The first five sessions are conducted weekly, and the last six sessions are conducted biweekly. A follow-up session is conducted three months after the end of the treatment. Repeated measurements (twice a week) are being collected throughout this period.
No_intervention: Randomized to waiting period of 4, 5 or 6 weeks
Participants are randomized to a 4, 5 or 6 week waiting period/baseline. Repeated measurements (twice a week) are being collected throughout this period.
Related Therapeutic Areas
Sponsors
Leads: Karlstad University
Collaborators: Region Örebro County, Region Stockholm, Region Värmland, Region Jönköping County

This content was sourced from clinicaltrials.gov