Nctid:
NCT06229327
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2023-10-21", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"children's anxiety scores", "timeFrame"=>"30 minutes", "description"=>"Child Anxiety Scale-Conditioning (min:0-maks:10)"}, {"measure"=>"children's fear scores", "timeFrame"=>"30 minutes", "description"=>"Child Fear Scale (min:0-maks:4)"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pediatric Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"19018160", "type"=>"RESULT", "citation"=>"Athanassiadou E, Tsiantis J, Christogiorgos S, Kolaitis G. An evaluation of the effectiveness of psychological preparation of children for minor surgery by puppet play and brief mother counseling. Psychother Psychosom. 2009;78(1):62-3. doi: 10.1159/000172623. Epub 2008 Nov 18. No abstract available."}, {"pmid"=>"26262772", "type"=>"RESULT", "citation"=>"Baranowski T, Blumberg F, Buday R, DeSmet A, Fiellin LE, Green CS, Kato PM, Lu AS, Maloney AE, Mellecker R, Morrill BA, Peng W, Shegog R, Simons M, Staiano AE, Thompson D, Young K. Games for Health for Children-Current Status and Needed Research. Games Health J. 2016 Feb;5(1):1-12. doi: 10.1089/g4h.2015.0026. Epub 2015 Aug 11."}, {"pmid"=>"28453316", "type"=>"RESULT", "citation"=>"Barton A, Ventura R, Vavrik B. Peripheral intravenous cannulation: protecting patients and nurses. Br J Nurs. 2017 Apr 27;26(8):S28-S33. doi: 10.12968/bjon.2017.26.8.S28."}, {"pmid"=>"36974915", "type"=>"RESULT", "citation"=>"Bawaeda O, Wanda D, Aprillia Z. Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Pediatr Med Chir. 2023 Mar 28;45(s1). doi: 10.4081/pmc.2023.315."}]}, "descriptionModule"=>{"briefSummary"=>"This study was carried out as a randomized controlled experimental study in order to evaluate the effect of therapeutic game use on anxiety and fear levels before indwelling catheter intervention in children aged 6-12 years followed in the hematology oncology service. A simple randomization method was used to assign children to groups. Ethics committee and institutional permission was obtained for the research. Research data were obtained from a total of 80 children, 40 interventions and 40 controls, hospitalized in Istanbul Medical Faculty Pediatric Hematology Service between October 2022 and August 2023.\n\nData; It was evaluated with the information form, child follow-up form, Child Anxiety Scale- State (ÇAS-D) and Child Fear Scale (CCS). For those assigned to the intervention group among the mother and child who signed the informed consent form; Before the indwelling catheter intervention, the children were shown the procedure on the amigrumi knitted baby developed by the researcher, the catheter application area was explained through the cardiovascular image and the catheter to be inserted was shown as an example. For those assigned to the control group; No intervention was applied other than the hospital\\'s normal procedure. Data were evaluated using the SPPS 26 (IBM Corp. IBM 1989, 2019. SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp.) package program. It was determined that the MCQ and ÇAS-D scores of the children in the intervention group were significantly lower than those in the control group (p˂0.01). It was determined that the mean CTA and respiratory rate of the children in the intervention group just before and 2 hours after the application were lower than the control group (p\\<0.001).\n\nAccording to the results of the research, it was determined that the therapeutic game applied before indwelling catheter intervention in children between the ages of 6-12 was effective in reducing children's anxiety and fear.", "detailedDescription"=>"According to the results of the research, it was determined that the therapeutic game applied before indwelling catheter intervention in children between the ages of 6-12 was effective in reducing children's anxiety and fear."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"6 years", "genderBased"=>true, "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Being between the ages of 6-12 Being diagnosed with cancer Receiving chemotherapy treatment It will be the first time that a permanent catheter will be inserted.\n\nExclusion Criteria:\n\n* Being in the terminal period Hearing and/or visual impairment Having another health problem or condition that will prevent communication (Turkish inability to speak...etc)"}, "identificationModule"=>{"nctId"=>"NCT06229327", "briefTitle"=>"Effects of Therapeutic Play on Anxiety and Fear", "organization"=>{"class"=>"OTHER", "fullName"=>"Okan University"}, "officialTitle"=>"The Effect of Therapeutic Play on Anxiety and Fear Levels Before Indwelling Catheter Intervention in Children Aged 6-12 Years Followed up in Hematology Oncology Service: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"0000-0002-4213-175X"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"PEDİATRİC", "description"=>"Children in the intervention group were played a therapeutic game explaining the procedure before indwelling catheter intervention. Children in the control group did not undergo any intervention other than the hospital's normal procedure before indwelling catheter intervention.", "interventionNames"=>["Behavioral: THERAPEUTICGAMES"]}], "interventions"=>[{"name"=>"THERAPEUTICGAMES", "type"=>"BEHAVIORAL", "description"=>"THERAPEUTICGAMES", "armGroupLabels"=>["PEDİATRİC"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34094", "city"=>"İ̇stanbul", "country"=>"Turkey", "facility"=>"Pinar Demirer", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Okan University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Istanbul University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate professor", "investigatorFullName"=>"Gülzade Uysal", "investigatorAffiliation"=>"Okan University"}}}}
