[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565793":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":52,"overallOfficials":32,"centralContacts":57,"locations":63,"responsibleParty":81,"collaborators":32,"id":85,"slug":32,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":32,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":32,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":105,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Coimbra","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":32},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Quality of Life","EQ-5D","at the beggining and up to 3 months",{"measure":14,"description":15,"timeFrame":12},"Pain","Visual scale from 0 to 10 to measure pain",{"measure":17,"description":18,"timeFrame":19},"Global perception of change","Patient Global Impression of Change scale (portuguese validated version)\n\n1 to 7 (1 is the worst, 7 is the best)","up to 3 months",[21,24,27,29],{"measure":22,"description":23,"timeFrame":12},"Well-being","EADS-21",{"measure":25,"description":26,"timeFrame":19},"Benefits perceived","Open question answered by the patients trough a written text",{"measure":28,"description":26,"timeFrame":19},"Difficulties perceived",{"measure":30,"description":31,"timeFrame":19},"Replicability and ease of introducing treatment in the context of the Portuguese national health service","Open questions and SWOT analysis",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","In the first phase, the questionnaire will be validated with all patients of the Family Health Unit diagnosed with fibromyalgia who agree to participate. Subsequently, all participants will be asked if they wish to participate in the intervention study, and those who agree will be randomized into either the intervention or control group. The intervention group will engage in Yoga practice with a certified yoga instructor, three times a week for three months. Quality of life scales, a well-being scale, and pain measurement on a numerical scale from 0 to 10 will be applied before and after the intervention, complemented by an open-ended question for qualitative analysis regarding perceived benefits and difficulties.","SUPPORTIVE_CARE",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","Fibromyalgia is a chronic and debilitating pain syndrome characterized by widespread and persistent pain, also affecting sleep quality and cognitive function. It is estimated to affect 3.6% of the population; however, since it is a condition that is often underdiagnosed, the actual numbers may be higher. It is also an incurable disease, so treatment is based on symptom management through pharmacological therapy, which is not always effective. Due to the inadequacy of pharmacological therapy, there is a need for complementary therapies, and despite the limited number of studies conducted in this area, some therapies based on meditative movement (notably yoga) are beginning to emerge, with beneficial effects reported on pain management and quality of life in these patients. Therefore, this study aims to investigate the benefits and feasibility of this type of intervention at the Primary Health Care level.",[42,46],{"label":43,"type":44,"description":45,"interventionNames":32},"Control group","NO_INTERVENTION","Group used as comparison.",{"label":47,"type":48,"description":49,"interventionNames":50},"Intervention group","EXPERIMENTAL","Yoga practioner group with a certified teacher, 3 times a week during 3 months.",[51],"Other: Yoga",[53],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"Yoga","Yoga with certified teacher, 3 times a week during 3 months.",[47],[58],{"name":59,"role":60,"phone":61,"phoneExt":32,"email":62},"Inês Rosendo Silva, MD PhD","CONTACT","(351) 918-4186","inesrcs@gmail.com",[64],{"facility":65,"status":32,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"USF Coimbra Centro","Coimbra","Coimbra District","3000-174","Portugal","PT",{"type":72,"coordinates":73},"Point",[74,75],-8.41996,40.20686,{"lat":75,"lon":74},[78],{"name":79,"role":60,"phone":80,"phoneExt":32,"email":62},"Inês R Silva, MD PhD","+351918418663",{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Ines Rosendo","PhD","100565793",false,"NCT06646796","Yoga Impact in Fibromyalgia, Primary Health Care","Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care","Inclusion Criteria:\n\n* Users of the Family Health Unit diagnosed with Fibromyalgia;\n* With cognitive capacity to answer the questionnaire;\n* With physical capacity to take part in Yoga classes.\n\nExclusion Criteria:\n\n* people under 18 years old.","ALL","18 Years",{"count":94,"type":95},20,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study aims to evaluate the effectiveness of a complementary therapy using Yoga within the scope of First Health Care in Portugal, in pain control, quality of life and well-being of the patients with Fibromyalgia. It also, pretends to assess the viability and to identify the barriers to this sort of therapy in the context of Primary Health Care.",[101],"Fibromyalgia",[101,103,54,104],"Chronic pain","Complementary and alternative medicine","NOT_YET_RECRUITING","2024-10-15",{"date":108,"type":109},"2024-10-17","ACTUAL",{"date":111,"type":95},"2024-12-01",{"date":113,"type":95},"2025-04-30",{"name":5,"class":6},1]