Nctid:
NCT06236477
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003693", "term"=>"Delirium"}, {"id"=>"D000071257", "term"=>"Emergence Delirium"}], "ancestors"=>[{"id"=>"D000003221", "term"=>"Confusion"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M6894", "name"=>"Delirium", "asFound"=>"Delirium", "relevance"=>"HIGH"}, {"id"=>"M772", "name"=>"Emergence Delirium", "asFound"=>"Emergence Delirium", "relevance"=>"HIGH"}, {"id"=>"M6446", "name"=>"Confusion", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"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"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"1:1 parallel-group, superiority randomized controlled trial"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>160}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-07", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-09", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pediatric Anesthesia Emergence Delirium Scale", "timeFrame"=>"day of surgery", "description"=>"Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome"}], "secondaryOutcomes"=>[{"measure"=>"The modified Yale Preoperative Anxiety Scale", "timeFrame"=>"day of surgery", "description"=>"Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome"}, {"measure"=>"Wong-Baker Faces Pain Rating Scale", "timeFrame"=>"day of surgery", "description"=>"Pain scale. Range 0-10, higher score indicates a worse outcome"}, {"measure"=>"Face, Legs, Activity, Cry, Consolability scale", "timeFrame"=>"day of surgery", "description"=>"Pain scale. Range 0-10, higher score indicates a worse outcome"}, {"measure"=>"Induction Compliance Checklist", "timeFrame"=>"day of surgery", "description"=>"Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome"}, {"measure"=>"Satisfaction survey", "timeFrame"=>"day of surgery", "description"=>"Survey of parental satisfaction with perioperative care. A qualitative survey with discrete questions that contain \"yes\" or \"no\" or likert-style ratings ranging from \"strongly disagree\" to \"strongly agree.\""}, {"measure"=>"Post Hospitalization Behavior Questionnaire", "timeFrame"=>"1 year", "description"=>"Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Anesthesia", "Music", "Pediatric Anesthesia", "Emergence Delirium"], "conditions"=>["Emergence Delirium"]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.", "detailedDescription"=>"Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.\n\nAim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"9 years", "minimumAge"=>"3 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Child aged 3-9 years\n* Presenting for unilateral or bilateral myringotomy under GA\n\nExclusion Criteria:\n\n* Combined procedures\n* Lack of interest in music (e.g., child who does not have musical preferences)\n* Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)\n* Parent/guardian or patient refusal"}, "identificationModule"=>{"nctId"=>"NCT06236477", "acronym"=>"DEAP Music", "briefTitle"=>"Decreasing Emergence Delirium With Personalized Music", "organization"=>{"class"=>"OTHER", "fullName"=>"Washington University School of Medicine"}, "officialTitle"=>"Decreasing Emergence Delirium With Personalized Music", "orgStudyIdInfo"=>{"id"=>"202309122"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Personalized Music Group", "description"=>"Those assigned to receive music will be asked to provide a short list of 5-10 songs familiar/well-known to the patient (specifically the song title and artist for each song). Songs will be downloaded onto an electronic mp3 player by the research staff member. The mp3 player will then be provided along with a portable Bluetooth speaker for use during the patient's perioperative period, loaded with the songs of their choice.", "interventionNames"=>["Behavioral: Personalized Music"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"No Music Group", "description"=>"Those not assigned to the personalized music group will receive standard care without music.", "interventionNames"=>["Behavioral: No Music"]}], "interventions"=>[{"name"=>"Personalized Music", "type"=>"BEHAVIORAL", "description"=>"Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care", "armGroupLabels"=>["Personalized Music Group"]}, {"name"=>"No Music", "type"=>"BEHAVIORAL", "description"=>"Participants will receive standard care without music.", "armGroupLabels"=>["No Music Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"63110", "city"=>"Saint Louis", "state"=>"Missouri", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Benjamin Sanofsky", "role"=>"CONTACT", "email"=>"sanofsky@wustl.edu", "phone"=>"314-457-3109"}, {"name"=>"Joel Hanns", "role"=>"CONTACT", "email"=>"joelhanns@wustl.edu", "phone"=>"636-541-2608"}], "facility"=>"Washington University in St. Louis", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}], "centralContacts"=>[{"name"=>"Benjamin Sanofsky", "role"=>"CONTACT", "email"=>"sanofsky@wustl.edu", "phone"=>"314-457-3109"}, {"name"=>"Joel Hanns", "role"=>"CONTACT", "email"=>"joelhanns@wustl.edu", "phone"=>"636-541-2608"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Washington University School of Medicine", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"The Society for Pediatric Anesthesia", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Anesthesiologist", "investigatorFullName"=>"Benjamin A Sanofsky", "investigatorAffiliation"=>"Washington University School of Medicine"}}}}
