[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527162":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":65,"collaborators":29,"id":68,"slug":29,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":29,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":29,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":29,"overallStatus":51,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Darkened room and star projector with parental presence","ACTIVE_COMPARATOR","Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.",[13,14],"Other: Dark with star projector","Other: Parental Presence",{"label":16,"type":10,"description":17,"interventionNames":18},"Preoperative midazolam 0.5 mg\u002Fkg po and parental presence","Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.",[19,14],"Drug: Preoperative midazolam",{"label":21,"type":10,"description":22,"interventionNames":23},"Parental presence alone","Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.",[14],[25,30,35],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Dark with star projector","When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Preoperative midazolam","Midazolam by mouth preoperatively.",[16],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Parental Presence","A parent or guardian will accompany the child into the OR and be present for the start of induction.",[9,21,16],[40],{"name":41,"affiliation":5,"role":42},"Natalie Barnett, M.D.","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},"Haley Nitchie, MHA","CONTACT","843-792-1869","nitchie@musc.edu",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Charleston","South Carolina","29425","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-79.93275,32.77632,{"lat":61,"lon":60},[64],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},{"type":42,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Natalie Barnett","Associate Professor-Faculty","100527162",false,"NCT06144177","Induction in the Dark","Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety","Inclusion Criteria\n\n* Age 2 to 6 years old\n* American Society of Anesthesiologists physical status I-II\n* Outpatient elective surgical procedures\n* Undergoing general anesthesia\n* Parent or guardian willing to be present during induction\n\nExclusion Criteria\n\n* History of previous surgery\n* Fear of the dark\n* Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.\n* Severe developmental delay\n* Severe obvious, preoperative anxiety\n* Patients currently using psychiatric medications\n* Non-English speaking","ALL","2 Years","6 Years",{"count":78,"type":79},240,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.\n\n1. darkened room and star projector with parental presence;\n2. preoperative midazolam 0.5 mg\u002Fkg by mouth and parental presence; or\n3. parental presence alone.",[85],"Anesthesia Induction","2026-06-17",{"date":88,"type":89},"2026-06-22","ACTUAL",{"date":91,"type":89},"2024-04-16",{"date":93,"type":79},"2027-05-22",{"name":5,"class":6},1]