[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563183":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":37,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Schulthess Klinik","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot testing",null,"A sample of n=20 Italian-speaking spine patients will complete the pre-final Italian version of the SQS and then be interviewed to discuss linguistic clarity and relevance. The same process will be performed with native German speakers for the German versions of the SQS",[13],"Other: Sleep Quality Scale (SQS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Field testing","A sample of n=100 Italian-speaking spine patients will complete the final translated Italian version of the SQS, together with the PSQI. The same process will be performed for n=100 German-speaking patients.",[13,18],"Other: Pittsburgh Sleep Quality Index (PSQI)",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Sleep Quality Scale (SQS)","For the pilot testing, each patient will complete the pre-final version of the SQS.\n\nThe patients involved in the field study will have to fill in the SQS twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.",[15,9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Pittsburgh Sleep Quality Index (PSQI)","The patients involved in the field test will have to fill in the PSQI twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Jacopo Vitale, Dr. PhD","CONTACT","0443857148","jacopo.vitale@kws.ch",{"name":35,"role":31,"phone":32,"phoneExt":10,"email":36},"Fabio Galbusera, Eng PhD","fabio.galbusera@kws.ch",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Zurich","Canton of Zurich","8008","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],8.55,47.36667,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":10,"phoneExt":10,"email":10},"Jacopo Vitale, Dr.",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100563183","validation-of-the-single-item-sleep-quality-scale-100563183",false,"NCT06612853","Validation of the Single-item Sleep Quality Scale","Cross-cultural Adaptation Into German and Italian, Validation, Reproducibility, and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients","SQS","Inclusion Criteria:\n\n* both male and female patients\n* German-speaking or Italian-speaking\n* diagnosis of spine pathology\n* age ≥ 14 years\n* cognitively intact (self-reported)\n\nExclusion Criteria:\n\n* pregnancy (self-reported)\n* medical and\u002For pharmacological treatment for sleep disorders\n* melatonin intake\n* daily use of smart-watch or applications for automatic sleep detection\n* inability to give informed consent","ALL","14 Years",{"count":67,"type":68},240,"ESTIMATED","OBSERVATIONAL","The single-item sleep quality scale (SQS) allows patients to provide a self-assessment of sleep quality over a 7-day recall period without significant additional burden. However, the SQS has not yet been utilized or validated in patients with spine pathologies. The main purpose of this study is to cross-culturally adapt the SQS from English to German and Italian and to test its validity in patients with back disorders. The study will be conducted in two stages. The first stage will involve the translation and cross-cultural adaptation of the SQS from English to German and Italian. The second stage will involve the evaluation of the instrument's face, content, and construct validity, reproducibility, and responsiveness in patients with back disorders.",[72],"Spine Disorder",[74,75,76,77,78,62,79],"Cross cultural adaptation","Translation","Validity","Reproducebility","Responsiveness","Sleep quality","2024-11-26",{"date":82,"type":83},"2024-11-29","ACTUAL",{"date":85,"type":83},"2024-10-01",{"date":87,"type":68},"2025-12-31",{"name":5,"class":6},1]