Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia.
- Who it may be relevant to
- Registry conditions: Vulvodynia (Chronic Vulvar Pain). Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia
Overview
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
Detailed 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).
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 ar
Primary outcome measures
- Change in pain during touch and/or insertion of an object [Time frame: 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.]
Secondary outcome measures (10)
- Change in sexual function [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Change in treatment goal attainment [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.]
- Change in pelvic floor tension [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.]
- Change in sexual satisfaction [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Change in interpersonal and self focused sexual goals [Time frame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up]
- Change in perceived intimacy [Time frame: Pre and post treatment (25 weeks after the baseline measurement started), and at 6 months follow-up]
- Change in life interference, sexual function interference and impact on relationship [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Change in depressive symptoms [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Change in anxiety symptoms [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Change in quality of life [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karlstad University — Karlstad
Identifiers
NCT: NCT06981611 · 2024-03946-01 · 2023-00377