[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585693":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Children\u002Fyoung adults with cleft lip and\u002For palate",null,"This group are children and young adults with a cleft lip and\u002For a cleft palate. They are 5, 12 or 22 years old.",[13,14],"Other: Questionnaires","Other: Semi-structured interviews",{"label":16,"type":10,"description":17,"interventionNames":18},"Children\u002Fyoung adults without a cleft","This group consists of healthy children and young adults. They will be age and gender matched to the group of children\u002Fyoung adults with a cleft.",[13],[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Questionnaires","The participants will fin in questionnaires about the financial and emotional burden they experience.",[9,16],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Semi-structured interviews","After the participants have filled in the questionnaires they will get the chance to participate in an interview to talk about their perceptions and experiences.",[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Tara Mouton","CONTACT","+32 496 44 63 08","tara.mouton@ugent.be",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ghent University Hospital","RECRUITING","Ghent","9000","Belgium","BE",{"type":43,"coordinates":44},"Point",[45,46],3.71667,51.05,{"lat":46,"lon":45},[49,53,54],{"name":50,"role":31,"phone":51,"phoneExt":10,"email":52},"Kristiane Van Lierde","+32 9 332 01 43","kristiane.vanlierde@uzgent.be",{"name":30,"role":31,"phone":51,"phoneExt":10,"email":33},{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Kristiane Van Lierde, Professor","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":6},"Research Foundation Flanders","100585693","the-financial-and-emotional-impact-of-cleft-palate-100585693",false,"NCT06905678","The Financial and Emotional Impact of Cleft Palate","The Financial and Emotional Impact of Cleft Palate on Children and Their Caregivers: a Mixed-method Study","Inclusion Criteria:\n\n* Presence of a cleft (lip and) palate\n* Age of 5, 12 or 18 years\n\nExclusion Criteria:\n\n\\- No specific exclusion criteria","ALL","4 Years","22 Years",{"count":73,"type":74},300,"ESTIMATED","1 Month","OBSERVATIONAL","Cleft lip and\u002For palate (CL±P) is the most prevalent congenital craniofacial defect with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. WHO highlights the significant financial costs, including morbidity, healthcare costs, emotional distress and social exclusion to patients, their families and society. The purpose of this study is to investigate the financial and emotional impact of CL±P based on the perceptions of children with CL±P and their parents\u002Fguardians followed by the interdisciplinary craniofacial teams of the University Hospitals of Leuven or Ghent. Participation in this study consists of completing questionnaires related to financial, social and well-being aspects using the CLEFT-Q, Parental Stress Scale and a financial impact questionnaire. The parents\u002Fguardians of the children aged 5 years always complete all questionnaires. The parents\u002Fguardians of the 12- and 18-year-old children complete the Parental Stress Scale and a financial impact questionnaire. The children aged 18 complete the CLEFT-Q themselves. Questionnaires can be delivered online or on paper. The outcomes on the health-related QoL of children with cleft and the PSS are compared with the outcomes of 'healthy' children and their parents\u002Fguardians to ensure that the emotional impact is attributable to the cleft. In addition, children and their parents\u002Fguardians can participate in a semi-structured interview. During the interview appointment, the questionnaires can be completed on paper. Potential participants will be told that the interview will be recorded and that all findings will be kept confidential. The actual interviews will take place at a location and time that is most convenient for the participants. Participants do not need to come to UZ Gent or UZ Leuven for this. Each interview will be recorded with a Roland R-05 high quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographic data. In addition, data regarding the type of cleft, diagnoses, observation sheets and consultation letters will be collected from the medical records of the children with CL±P. We also aim to investigate whether variations in these effects are observable based on the specific type of cleft. All participants will go through the same protocol regardless of recruitment through UZ Gent or UZ Leuven.",[79],"Cleft Lip and Cleft Palate",[81,82,83,21,84,85],"Cleft lip and palate","Emotional burden","Financial burden","Perceptions","Interviews","2025-03-25",{"date":88,"type":89},"2025-04-01","ACTUAL",{"date":91,"type":89},"2025-03-01",{"date":93,"type":74},"2027-12",{"name":5,"class":6},1]