Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

Karlstad University

Status: Enrolling

Conditions: Vulvodynia (Chronic Vulvar Pain)

Treatments: Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Study type: Interventional

Funder types: Other

Identifiers

NCT06981611

2024-03946-01

2023-00377 (Other Grant/Funding Number)

Details and patient eligibility

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

Full description

The study design consists of a mixed-methods design, where different methods are applied in the various sub-studies of the project.

Study 1, is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, replicated across five healthcare contexts (n≈10-15 per unit, total N≈50-75).

Potential participants will be informed about the study at their health care unit and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment. After the assessment interview and inclusion, participants will be randomized to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up, using the secure survey system called Survey and Report. through Karlstad university. The outcome measures are based on the ongoing work by the Swedish Agency for Health Technology Assessment and Assessment of Social Services.

Study 2, is a qualitative evaluation and initial assessment of the possibilities for implementing the treatment in the Swedish healthcare context.

Individual interviews with patients will be conducted and questions will be asked regarding their experience of the treatment model. Focus group interviews will be conducted with practitioners and questions will be asked regarding relevance, relative advantages, consistency with standard practices, usability, and adaptability. Since the treatment will be carried out in five healthcare units with different organizational and practical conditions, questions will specifically address unit-specific aspects that therapists and patients perceive as having facilitated or hindered the implementation and what could be improved in both treatment content and execution. The questions are based on the recommendations of the Swedish National Board of Health and Welfare and the Public Health Agency regarding the initial assessment of implementation possibilities.

To obtain the healthcare organization's perspective on implementation possibilities, interviews will be held with health care stakeholders within the participating healthcare units. These interviews will also focus on relevance, relative advantages, consistency with standard practices, usability, and adaptability.

The individual and focus group interviews will be conducted in person at the health care units or through digital video meetings. Data from focus group interviews and individual interviews will be recorded by audio, transcribed, and analyzed according to standard qualitative analysis methods, primarily inductive empirically driven Thematic Analysis (TA).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Experimental group

Description:

A multimodal treatment consisting of approximately 11 treatment sessions, for provoked vulvodynia. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, via digital video meetings and meetings at the health care facilities. The first five sessions are conducted weekly, and the last six sessions are conducted biweekly. A follow-up session is conducted three months after the end of the treatment. Repeated measurements (twice a week) are being collected throughout this period.

Treatment:

Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Randomized to waiting period of 4, 5 or 6 weeks

No Intervention group

Description:

Participants are randomized to a 4, 5 or 6 week waiting period/baseline. Repeated measurements (twice a week) are being collected throughout this period.