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Clinical Trials in Sweden / NCT06981611
Active, not recruiting Not applicable

Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

NCT06981611 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karlstad University
Phase
Not applicable
Started
2025-03-11
Last updated
2026-08-12

Condition(s) studied

Vulvodynia (Chronic Vulvar Pain)

Investigational drug(s) / intervention(s)

Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia: The intervention is based around physiological and psychosocial components working with goal-directed behavioral change. Includes both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are approximately 60 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in pain during touch and/or insertion of an object — Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks.
    Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.

Trial sites (1)

FacilityCityRegionStatus
Karlstad University Karlstad Sweden

More Karlstad University trials in Sweden

Floor-hugging Intervention: Managing Fear of Falling Through Floor Exposure and Developing After-fall Contingency Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06981611 on ClinicalTrials.gov ↗ ← All trials in Sweden