Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT06981611

Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

Led by Karlstad University · Updated on 2025-05-21

50

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

Sponsors

K

Karlstad University

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biological sex: Female
  • Age between 18 and 40 years old
  • Diagnosed with provoked vulvodynia
Not Eligible

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 requiring different treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Karlstad University

Karlstad, Sweden

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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