[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657973":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":58,"collaborators":23,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":23,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":23,"maxAge":23,"enrollmentInfo":69,"targetDuration":23,"studyType":72,"phases":23,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":84,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Atılım University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Pittsburgh Sleep Quality Index (PSQI)","Parental sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire evaluating sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 indicates poor sleep quality.","At baseline (single assessment)",{"measure":14,"description":15,"timeFrame":12},"Zarit Burden Interview","Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a 22-item self-report questionnaire evaluating the physical, emotional, social, and economic burden of caregiving. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden.",{"measure":17,"description":18,"timeFrame":19},"Parenting Stress Index-Short Form (PSI-SF)","Parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item questionnaire comprising three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36 to 180, with higher scores indicating greater parenting stress.","At baseline (single assessment).",{"measure":21,"description":22,"timeFrame":12},"Parental Self-Efficacy Scale","Parental self-efficacy will be assessed using the 17-item Parental Self-Efficacy Scale. The Turkish version will be used to evaluate parents' perceived confidence in their parenting abilities. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), yielding a total score ranging from 17 to 119. Higher scores indicate greater parental self-efficacy and therefore a better outcome.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","CROSS_SECTIONAL","Children with spastic diplegic cerebral palsy may experience sleep disturbances that can affect their parents' sleep quality and caregiving responsibilities. Night orthoses are commonly used in the management of cerebral palsy; however, their relationship with parental sleep quality and psychosocial outcomes remains unclear.\n\nThis observational, comparative study will include approximately 150 parents of children with spastic diplegic cerebral palsy. Participants will be divided into two groups: parents of children who use night orthoses and parents of children who do not use night orthoses.\n\nParental sleep quality, caregiver burden, stress, and self-efficacy will be assessed using standardized questionnaires. The outcomes will be compared between the two groups to examine potential associations with night orthosis use.\n\nThe findings may contribute to a better understanding of the relationship between night orthosis use and parental well-being and may help inform family-centered rehabilitation approaches.","Approximately 150 parents of children aged 6-15 years with spastic diplegic cerebral palsy will be included. Parents will be classified into two groups according to their children's existing night orthosis use. Parental sleep quality, caregiver burden, parenting stress, and self-efficacy will be compared between groups.",[30,33],{"label":31,"type":23,"description":32,"interventionNames":23},"Parents of Children Using Night Orthoses","Parents of children with spastic diplegic cerebral palsy who regularly use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed.",{"label":34,"type":23,"description":35,"interventionNames":23},"Parents of Children Not Using Night Orthoses","Parents of children with spastic diplegic cerebral palsy who do not use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed.",[37],{"name":38,"affiliation":5,"role":39},"Süleyman Korkusuz, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},"CONTACT","+905388675480","suleyman.korkusuz@atilim.edu.tr",[46],{"facility":5,"status":23,"city":47,"state":23,"zip":23,"country":48,"countryCode":23,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Ankara","Turkey (Türkiye)",{"type":50,"coordinates":51},"Point",[52,53],32.85427,39.91987,{"lat":53,"lon":52},[56],{"name":38,"role":42,"phone":57,"phoneExt":23,"email":44},"+90 538 867 54 80",{"type":39,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Süleyman Korkusuz","Assist. Prof. Dr","100657973","sleep-quality-caregiver-burden-stress-and-self-efficacy-in-parents-of-children-with-spastic-diplegic-cerebral-palsy-a-comparison-by-night-orthosis-use-100657973",false,"NCT07846917","Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use","Comparison of Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy Between Parents of Children With Spastic Diplegic Cerebral Palsy Who Use and Do Not Use Night Orthoses","Inclusion Criteria:\n\n* Being the parent of a child aged 6-15 years diagnosed with spastic diplegic cerebral palsy.\n* Being the child's primary caregiver.\n* Having provided active care for at least 6 months.\n* Being literate.\n\nProviding informed consent to participate in the study.\n\nExclusion Criteria:\n\nParent-related criteria:\n\n* Having a diagnosed severe psychiatric disorder.\n* Regular use of medications affecting sleep patterns (e.g., sedatives).\n* Having a severe chronic disease (e.g., advanced cardiac or renal disease).\n* Having experienced a major acute stressor (e.g., bereavement or trauma) within the previous month.\n* Having a primary neurological disorder directly affecting sleep.\n\nChild-related criteria:\n\n* Having undergone orthopedic surgery within the previous 3 months.\n* Having received botulinum toxin injections within the previous 3 months.\n* Having severe epilepsy or a history of uncontrolled seizures.","ALL",{"count":70,"type":71},150,"ESTIMATED","OBSERVATIONAL","This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.",[75,76,77],"Cerebral Palsy","Sleep Disorders","Caregiver Burden",[79,80,81,77,82,83],"Spastic Diplegic Cerebral Palsy","Night Orthosis","Sleep Quality","Parental Stress","Parental Self-Efficacy","NOT_YET_RECRUITING","2026-10-05",{"date":87,"type":88},"2026-10-08","ACTUAL",{"date":90,"type":71},"2026-11-01",{"date":92,"type":71},"2027-01-01",{"name":5,"class":6},1]