[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Karlstad University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Vulvodynia (Chronic Vulvar Pain)",[29,30,31,32,33,34,35,36,37,38],"Vulvodynia","Provoked vulvodynia","multimodal treatment","cognitive behavioral therapy","cbt","couple treatment","single-case experimental design","sced","chronic pain","Vulvodynia Intervention","RECRUITING","2025-05-12",{"date":42,"type":43},"2025-05-21","ACTUAL",{"date":45,"type":43},"2025-02-10",{"date":47,"type":21},"2026-12-31",{"name":49,"class":50},"Karlstad University","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":51},"100578785","floor-hugging-intervention-managing-fear-of-falling-through-floor-exposure-and-developing-after-fall-contingency-100578785","NCT06815809","Floor-hugging Intervention: Managing Fear of Falling Through Floor Exposure and Developing After-fall Contingency","Floor-HI","Inclusion Criteria:\n\n* Participants must be healthy adults between the ages of 18 and 64.\n* Participants must be fluent in either Swedish or English.\n* Participants must have a Montreal Cognitive Assessment (MoCA) score of 23 or higher.\n* Participants must be able to perform activities of daily living independently.\n\nExclusion Criteria:\n\n* Participants with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis, traumatic brain injury, etc.).\n* Participants with musculoskeletal disorders (e.g., rheumatoid arthritis, sprains, strains, etc.).\n* Participants with severe cognitive impairments (Montreal Cognitive Assessment score \\\u003C 23).\n* Participants with psychiatric disorders (e.g., bipolar disorder, schizophrenia).\n* Participants currently involved in any other exercise-based interventions that involves prolonged floor contact (e.g., yoga, martial arts, dance).",true,"ALL","64 Years",{"count":63,"type":21},48,[24],"Fear of falling is a major public health problem and is characterized by a lack of confidence in one's ability to maintain balance and prevent falls. The fear can range from reasonable precautions to avoid slippery surfaces to an overwhelming fear that prevents people from performing everyday activities. Several factors contribute to this fear, including physical, psychological, social and environmental factors. These factors can not only lead to an increased tendency to fall, but also to increased anxiety, depression and social isolation, which can ultimately impair the individual's physical and mental health. Current approaches to help have only limited or moderate success, often because they do not take into account how the environment affects people's relationship with the floor.\n\nFor example, in urbanized societies, people spend less time in contact with the floor, which may have led to an individual's perception of the floor changing. This connection is not only physical, but can also involve a lack of mental and sensory familiarity. Without regular interaction with the floor in different positions, the individual may feel insecure or unfamiliar with the floor. This unfamiliarity can increase anxiety and encourage hypervigilant behavior that can lead to a fear of falling. Similarly, unfamiliarity with the floor can also contribute to a person's ability to respond effectively to a fall, often leaving the person unsure of what steps to take next.\n\nThe Floor-Hugging Intervention (Floor-HI) is a new intervention that can address these issues. The intervention consists of three main parts: learning how to get down on the floor, familiarizing oneself with the floor, and learning how to get back up. In the first part, participants learn how to lie down on the floor using evidence-based methods. The participant then practices lying on the floor to become more comfortable and less anxious. By repeatedly practicing lying on the floor in a safe environment, the intervention aims to break the connection between the floor and the fear associated with it, while promoting a more positive and confident mindset.\n\nThe third part of Floor-HI is to teach strategies for getting up from the floor. This is important to help participants gain the confidence and physical strength to recover from falls. Participants are given practice in different ways to get up, first with the help of furniture and then without assistance. The training aims not only to improve participants' physical abilities but also their confidence in dealing with falls.\n\nEach session of the Floor HI programme is designed to last 1 hour and to be performed three times a week for three weeks. The training would be divided equally between getting used to the floor and learning to stand up. The results of the programme would be evaluated by assessing its impact on participants' fear of falling, static and dynamic balance, fall frequency, ability to get up from the floor and general quality of life. In addition, the acceptability of the intervention and any adverse events occurring as a result of participation in the intervention will also be collected. In conclusion, Floor-HI can be a good way to manage the fear of falling by focusing on both mental and physical aspects, which can ultimately help people to live more active and fulfilling lives.",[67,68,69],"Fear of Falling","Balance Changes","Healthy",[71,72,73],"Fear of falling","Balance assessment","After fall contingency","2025-02-11",{"date":76,"type":43},"2025-02-14",{"date":74,"type":43},{"date":79,"type":21},"2027-10",{"name":49,"class":50},""]