Nctid:
NCT06612398
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001008", "term"=>"Anxiety Disorders"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "asFound"=>"Anxiety", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"Research Assistant who evaluated patient's anxiety levels did not know who watched the intervention and who did not."}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Randomized controlled trial"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>84}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-08-30", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"modified Yale Preoperative Anxiety Scale", "timeFrame"=>"1 day", "description"=>"Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety"}, {"measure"=>"Visual Facial Anxiety Scale", "timeFrame"=>"1 day", "description"=>"Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety"}], "secondaryOutcomes"=>[{"measure"=>"Face, Legs, Activity, Cry, Consolability scale", "timeFrame"=>"1 day", "description"=>"Observational pain scale, values (0-10) with higher scores indicating higher levels of pain"}, {"measure"=>"Pediatric Anesthesia Emergence Delirium scale", "timeFrame"=>"1 day", "description"=>"Observational emergence delirium scale, values (0-20) with higher scores indicating higher levels of emergence delirium"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Preoperative Anxiety"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8953995", "type"=>"BACKGROUND", "citation"=>"Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. 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Relationship between subjective and objective measures of anticipatory anxiety prior to extraction procedures in 8- to 12-year-old children. J Dent Anesth Pain Med. 2021 Apr;21(2):119-128. doi: 10.17245/jdapm.2021.21.2.119. Epub 2021 Mar 31."}, {"pmid"=>"36974915", "type"=>"BACKGROUND", "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."}, {"pmid"=>"27294708", "type"=>"BACKGROUND", "citation"=>"Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1."}, {"pmid"=>"26474268", "type"=>"BACKGROUND", "citation"=>"Batuman A, Gulec E, Turktan M, Gunes Y, Ozcengiz D. Preoperative informational video reduces preoperative anxiety and postoperative negative behavioral changes in children. Minerva Anestesiol. 2016 May;82(5):534-42. Epub 2015 Oct 16."}, {"pmid"=>"30944985", "type"=>"BACKGROUND", "citation"=>"Vagnoli L, Bettini A, Amore E, De Masi S, Messeri A. Relaxation-guided imagery reduces perioperative anxiety and pain in children: a randomized study. Eur J Pediatr. 2019 Jun;178(6):913-921. doi: 10.1007/s00431-019-03376-x. Epub 2019 Apr 3."}, {"pmid"=>"15562048", "type"=>"BACKGROUND", "citation"=>"Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97."}, {"pmid"=>"10320165", "type"=>"BACKGROUND", "citation"=>"Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013."}, {"pmid"=>"29481436", "type"=>"BACKGROUND", "citation"=>"Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864."}, {"pmid"=>"16996689", "type"=>"BACKGROUND", "citation"=>"von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25."}, {"pmid"=>"7828247", "type"=>"BACKGROUND", "citation"=>"Goresky GV, Whitsett SF. Psychological preparation of children for surgery. Can J Anaesth. 1994 Nov;41(11):1033-5. doi: 10.1007/BF03015649. No abstract available. English, French."}, {"pmid"=>"8872693", "type"=>"BACKGROUND", "citation"=>"Kain ZN, Mayes LC, Caramico LA. Preoperative preparation in children: a cross-sectional study. J Clin Anesth. 1996 Sep;8(6):508-14. doi: 10.1016/0952-8180(96)00115-8."}]}, "descriptionModule"=>{"briefSummary"=>"The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).", "detailedDescription"=>"This randomised controlled trial, conducted at King Abdullah University Hospital (KAUH) over an eight-month period from February to October 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under GA. Participants were randomly assigned to either the control group or the study group. Participants in the control group received the standard care provided upon arrival at the Day Case Unit (DCU) at KAUH, involving only a verbal explanation of the anaesthesia induction process. In contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Additionally, all parents watched the video alongside their children and provided positive comments on its content. The primary outcome assessed was the children's preoperative anxiety measured by modified Yale Preoperative Anxiety Scale (m-YPAS) and Visual Facial Anxiety Scale (VFAS), allowing for an evaluation of the intervention's impact."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"7 years", "minimumAge"=>"4 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.\n* Age 4-7 years.\n* Children undergoing GA for the first time who require comprehensive dental rehabilitation.\n\nExclusion Criteria:\n\n* Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.\n* Presence of visual or auditory disability.\n* Participants who refuse to answer subjective scales due to heightened anxiety levels.\n* Participants with no access to internet services.\n* Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety."}, "identificationModule"=>{"nctId"=>"NCT06612398", "briefTitle"=>"Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA", "organization"=>{"class"=>"OTHER", "fullName"=>"King Abdullah University Hospital"}, "officialTitle"=>"Effect of a Preoperative Preparation Video on Preoperative Anxiety Among Children Undergoing Dental Treatment Under General Anesthesia", "orgStudyIdInfo"=>{"id"=>"72/149/2022"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Standard of care", "description"=>"Participants received the standard care provided upon arrival and being admitted to the hospital, involving only a verbal explanation of the anaesthesia induction process."}, {"type"=>"EXPERIMENTAL", "label"=>"Preoperative preparation video", "description"=>"On the night before the surgery, participants were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.", "interventionNames"=>["Behavioral: Preoperative preparation video"]}], "interventions"=>[{"name"=>"Preoperative preparation video", "type"=>"BEHAVIORAL", "description"=>"An animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.", "armGroupLabels"=>["Preoperative preparation video"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Irbid", "country"=>"Jordan", "facility"=>"Jordan University of Science and Technology", "geoPoint"=>{"lat"=>32.55556, "lon"=>35.85}}], "overallOfficials"=>[{"name"=>"Mawia Bataineh, Doctor", "role"=>"STUDY_CHAIR", "affiliation"=>"Jordan University of Science and Technology"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"King Abdullah University Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Jordan University of Science and Technology", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
