Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

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

Conditions

• Vulvodynia (Chronic Vulvar Pain)

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• Region Örebro County

  collaborator OTHER

• Region Jönköping County

  collaborator OTHER_GOV

• Region Värmland

  collaborator UNKNOWN

• Karlstad University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-10

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Sweden

Study Locations