[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591529":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":42,"collaborators":46,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":26,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Karlstad University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia","EXPERIMENTAL","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.",[13],"Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia",{"label":15,"type":16,"description":17,"interventionNames":18},"Randomized to waiting period of 4, 5 or 6 weeks","NO_INTERVENTION","Participants are randomized to a 4, 5 or 6 week waiting period\u002Fbaseline. Repeated measurements (twice a week) are being collected throughout this period.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","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.",[9],[25],{"facility":5,"status":26,"city":27,"state":18,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RECRUITING","Karlstad","Sweden","SE",{"type":31,"coordinates":32},"Point",[33,34],13.50357,59.3793,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Principal Investigator: Ida Flink, professor","CONTACT","+4672-156 44 49","ida.flink@kau.se",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ida Flink","Professor in psychology",[47,50,52,54],{"name":48,"class":49},"Region Stockholm","OTHER_GOV",{"name":51,"class":6},"Region Örebro County",{"name":53,"class":49},"Region Jönköping County",{"name":55,"class":56},"Region Värmland","UNKNOWN","100591529","vulvodynia-intervention-the-effect-of-multimodal-treatment-for-provoked-vulvodynia-100591529",false,"NCT06981611","Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia","Vulvodynia Intervention (VI): the Effect of Multimodal Treatment for Provoked Vulvodynia","Inclusion Criteria:\n\nBiological sex: Female 18-40 years old Provoked vulvodynia\n\nExclusion Criteria:\n\n* Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)\n* Ongoing pregnancy\n* Childbirth within the last year\n* Post-traumatic stress disorder (PTSD) related to sexual trauma\n* Insufficient mastery of the Swedish language\n* No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment","FEMALE","18 Years","40 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions:\n\n1. What is the feasibility and acceptability of this multimodal treatment protocol?\n2. What are the effects on pain and psychosexual health?\n3. How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation?\n\nParticipants 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.\n\nThe participants will:\n\n* Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition\n* Undergo a multimodal treatment\n* Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment\n* Be asked to participate in an interview about their experience of the treatment and intimacy",[75],"Vulvodynia (Chronic Vulvar Pain)",[77,78,79,80,81,82,83,84,85,86],"Vulvodynia","Provoked vulvodynia","multimodal treatment","cognitive behavioral therapy","cbt","couple treatment","single-case experimental design","sced","chronic pain","Vulvodynia Intervention","2025-05-12",{"date":89,"type":90},"2025-05-21","ACTUAL",{"date":92,"type":90},"2025-02-10",{"date":94,"type":69},"2026-12-31",{"name":5,"class":6},1]