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Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

Active, not recruitingNot applicableNCT06981611
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
Conditions
  • Vulvodynia (Chronic Vulvar Pain)
Interventions
  • Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia
Sponsor
Karlstad University
Collaborators
Region Stockholm; Region Örebro County; Region Jönköping County; Region Värmland
Start date
2025-03-11
Primary completion
2026-12-31
Sex
Female
Age range
from 18 Years to 40 Years
Results posted
No results posted in this snapshot
Countries
Sweden
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06981611