About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in pain during touch and/or insertion of an object
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.
Secondary outcomes
Change in sexual function
The Female Sexual Function Index (FSFI) is a self-report measure of female sexual function that assesses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. It consists of 19 questions, rated on a 5-point scale, with a higher score indicating a better sexual function.
Change in treatment goal attainment
Participants chose an individual treatment goal and rate treatment goal attainment, from 0-10, 0= the goal is not at all achieved, 10= the goal is achieved.
Change in pelvic floor tension
Self-report assessment of pelvic floor tension and pelvic floor relaxation. Two items rated on a 11-point scale, from 0-10, higher scores indicate greater tension and more difficulty relaxing the pelvic floor, and physiotherapeutic examination.
Change in sexual satisfaction
Global measure of sexual satisfaction (GMSEX), 5 items rated on a 7-point scale. Higher scores indicate a higher degree of sexual satisfaction.
Other outcomes
Evaluation of how much time participants spend on the treatment and related exercises
Demographic
Age, country of birth, educational level, occupation, if they have a partner/-s, how long they have been in that relationship/-s, gender of partner/-s, if they have kids, childbirth during the last year, ongoing pregnancy, menstruation
Change in sexual desire and arousal
Two items from the female sexual function index, measuring sexual desire and arousal, rated on a 5-point scale. Higher scoring indicate greater sexual desire and arousal.
Change in pain catastrophizing
Pain catastrophizing scale (PCS) evaluates participants negative cognitive and emotional reactions to pain. It assesses the extent of catastrophic thinking due to pain according to three subscales: rumination, magnification and helplessness. 13 items rated on a 5-point scale from 0 (not at all) to 4 (all the time). Higher scores indicating greater levels of pain catastrophizing.
Sponsors and contacts
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Karlstad University
Lead sponsor
Region Stockholm
Collaborator
Region Örebro County
Collaborator
Region Jönköping County
Collaborator
Region Värmland
Collaborator