Nctid:
NCT06224322
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002547", "term"=>"Cerebral Palsy"}, {"id"=>"D000084802", "term"=>"Caregiver Burden"}], "ancestors"=>[{"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000001925", "term"=>"Brain Damage, Chronic"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000013315", "term"=>"Stress, Psychological"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M2480", "name"=>"Caregiver Burden", "asFound"=>"Caregiver Burden", "relevance"=>"HIGH"}, {"id"=>"M13157", "name"=>"Paralysis", "relevance"=>"LOW"}, {"id"=>"M5796", "name"=>"Cerebral Palsy", "asFound"=>"Cerebral Palsy", "relevance"=>"HIGH"}, {"id"=>"M5207", "name"=>"Brain Injuries", "relevance"=>"LOW"}, {"id"=>"M5202", "name"=>"Brain Damage, Chronic", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M16105", "name"=>"Stress, Psychological", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-09-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Zarit Caregiven Burden scale", "timeFrame"=>"Preoperative, Postoperative three, six and twelve month", "description"=>"The 22-item instrument is included in this scale. Each item in the questionnaire is a statement that the carer is asked to confirm using a 5-point scale. The answer options range from 0 (Never) to 4 (Almost Always)."}], "secondaryOutcomes"=>[{"measure"=>"Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module", "timeFrame"=>"Preoperative, Postoperative three, six and twelve month", "description"=>"This scale was developed by James James in 2004 to measure the effects of a child with an illness on family functioning. It was developed by Varni. It consists of 6 sub-factors and 36 statements. Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Concern (5 items) and 2 subscales measuring parent-reported family functioning; 7) Daily Activities (3 items) and Family Relationships (5 items)."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cerebral Palsy", "Care Giving Burden"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are:\n\nQ1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.", "detailedDescription"=>"One of the most common causes of disability in childhood is cerebral palsy, which develops due to damage to the central nervous system. Children diagnosed with cerebral palsy face different problems in every period of their lives. The child, his/her family and the society he/she lives in should be considered as a whole. There is a mechanism that mutually affects each other.\n\nParenting, caring for and living with a child with cerebral palsy can have many negative effects on the lives of parents and create additional burdens for them. Parents may have to choose between their own needs, the needs of other members of the family and the needs of the child with cerebral palsy, and may spend most of their time with their disabled child. This can negatively affect the burden, stress level, physical activity level, quality of life, psychological status and self-efficacy perception.\n\nThe primary aim of this study is to evaluate the caregiver burden in Cerebral Palsy, which is the most common cause of morbidity in the pediatric age group in orthopedics, and to analyze the factors that negatively affect it. Our hypothesis is that the functional mobilization status of patients will increase, especially as a result of hip surgeries, reducing caregiver burden."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"20 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Our study will be conducted with the parents of children with cerebral palsy who are admitted to the Orthopaedics Unit of Istanbul Medical Faculty and will be operated on in the knee-hip region.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Parent Age\n\n a. Being in the 20-60 age group.\n2. Diagnosis\n\n 1. Having a child with clinically diagnosed cerebral palsy\n 2. The movement scale of the cerebral palsy patient is between GMFS 3 and 5\n3. A minimum follow-up of 12 months after surgery\n4. The primary carer is the mother or father\n\nExclusion Criteria:\n\n1. The patient and his/her family have been lost to follow-up\n2. Having another disabled person in need of care in the family\n3. Family's unwillingness to participate in the study\n4. Loss of a parent"}, "identificationModule"=>{"nctId"=>"NCT06224322", "acronym"=>"Caregiver CP", "briefTitle"=>"Caregiver Burden in Cerebral Palsy Undergoing Hip and Knee Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Istanbul University"}, "officialTitle"=>"Evaluation of Factors Affecting Caregiver Burden in Cerebral Palsy Patients Undergoing Hip and Knee Surgery", "orgStudyIdInfo"=>{"id"=>"2234234"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Cerebral Palsy Patients Parent", "description"=>"Parents of patients who underwent knee and hip surgery for cerebral palsy", "interventionNames"=>["Other: Assesment Scale"]}], "interventions"=>[{"name"=>"Assesment Scale", "type"=>"OTHER", "otherNames"=>["Questionnaire"], "description"=>"Caregiving burden will be assessed with Turkish validated scoring tools such as the Zarit scale and the Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module before and after surgery.", "armGroupLabels"=>["Cerebral Palsy Patients Parent"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34080", "city"=>"Istanbul", "state"=>"Fatih-Topkapı", "status"=>"RECRUITING", "country"=>"Turkey", "contacts"=>[{"name"=>"Ahmet M YILDIRIM, Assistant", "role"=>"CONTACT", "email"=>"ahmet.yildirim.93@istanbul.edu.tr", "phone"=>"090 212 414 2000", "phoneExt"=>"31516"}], "facility"=>"Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}, {"zip"=>"34080", "city"=>"Istanbul", "state"=>"Fatih", "status"=>"RECRUITING", "country"=>"Turkey", "contacts"=>[{"name"=>"Ahmet Muçteba AM Yıldırım, Fellow", "role"=>"CONTACT", "email"=>"mucceba@gmail.com", "phone"=>"+090 534 303 8472"}], "facility"=>"Istanbul Unıversity Medicine Faculty Orthopaedic Department", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "centralContacts"=>[{"name"=>"Ahmet Muçteba AM Yıldırım, Fellow", "role"=>"CONTACT", "email"=>"mucceba@gmail.com", "phone"=>"+090 534 3038472"}], "overallOfficials"=>[{"name"=>"Mehmet MD Demirel, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Assistant Professor"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Maybe one year later ı am going to share ıpd"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Istanbul University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"AHMET MUCTEBA YILDIRIM", "investigatorAffiliation"=>"Istanbul University"}}}}
