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Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing
    • Start date: Feb 10, 2025 to Mar 11, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06981611
Lead Sponsor Karlstad University
Collaborators: Region Stockholm, Region Örebro County, Region Jönköping County, Region Värmland
Conditions
(from sponsor)		 Vulvodynia (Chronic Vulvar Pain)
Related terms Chronic Pain, Color Vision Defects, Vulvodynia
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov