Nctid:
NCT06235723
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073818", "term"=>"Pain, Procedural"}, {"id"=>"D000001008", "term"=>"Anxiety Disorders"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "asFound"=>"Anxiety", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M1219", "name"=>"Pain, Procedural", "asFound"=>"Procedural Pain", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>38}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2023-12-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-02-09", "studyFirstSubmitDate"=>"2023-12-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-20", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)", "timeFrame"=>"pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)", "description"=>"Virtual Reality vs. Standard-of-Care"}, {"measure"=>"Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)", "timeFrame"=>"pre-, peri-interventional (before puncture when entering intervention room and during puncture)", "description"=>"Virtual Reality vs. Standard-of-Care"}, {"measure"=>"Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)", "timeFrame"=>"pre-, peri-interventional (before puncture when entering intervention room and during puncture)", "description"=>"Virtual Reality vs. Standard-of-Care"}], "secondaryOutcomes"=>[{"measure"=>"Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)", "timeFrame"=>"post-interventional (immediately after the intervention)", "description"=>"Parents and patients were given different statements"}, {"measure"=>"Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)", "timeFrame"=>"through study completion, ~ 1.5 years in total", "description"=>"Involved staff were asked about experience/feedback"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Virtual Reality", "Pediatric Oncoloy", "Outpatient Clinic", "Peri-interventional Pain"], "conditions"=>["Pediatric Cancer", "Procedural Anxiety", "Procedural Pain"]}, "descriptionModule"=>{"briefSummary"=>"Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.\n\nIn a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* aged 6-18 years\n* any sex\n* port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic\n* hematological or oncological diagnosis\n* informed consent\n\nExclusion Criteria:\n\n* epilepsy\n* coronary artery disease\n* history of severe vertigo\n* obstacles to putting on and wearing VR glasses\n* lack of informed consent for study participation."}, "identificationModule"=>{"nctId"=>"NCT06235723", "briefTitle"=>"Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic", "organization"=>{"class"=>"OTHER", "fullName"=>"Hannover Medical School"}, "officialTitle"=>"Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"VirtualReality2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"SOC (A)", "description"=>"SOC = Standard-of-Care"}, {"type"=>"EXPERIMENTAL", "label"=>"VR (B)", "description"=>"VR = Virtual Reality", "interventionNames"=>["Device: Virtual Reality"]}], "interventions"=>[{"name"=>"Virtual Reality", "type"=>"DEVICE", "description"=>"Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.", "armGroupLabels"=>["VR (B)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"30625", "city"=>"Hanover", "state"=>"Lower Saxony", "country"=>"Germany", "facility"=>"Medical School Hanover", "geoPoint"=>{"lat"=>52.37052, "lon"=>9.73322}}], "overallOfficials"=>[{"name"=>"Urs Mücke, Dr.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Hannover Medical School"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hannover Medical School", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
