[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523273":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":92,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3mg fast-dissolve pill","PLACEBO_COMPARATOR","Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.",[13],"Other: Fast-Dissolve Placebo Pill",{"label":15,"type":16,"description":17,"interventionNames":18},"3mg fast-dissolve pill (containing melatonin)","EXPERIMENTAL","Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.",[19],"Dietary Supplement: Fast-Dissolve Melatonin Pill",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Fast-Dissolve Melatonin Pill","Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Fast-Dissolve Placebo Pill","Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jennifer A Rabbitts, M.B.Ch.B.","CONTACT","(650) 427-0187","surgerysmart@stanford.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Lucile Packard Children's Hospital","RECRUITING","Palo Alto","California","94304","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-122.14302,37.44188,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Jennifer A Rabbitts, M.D.","650-725-0540","rabbitts@stanford.edu",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jennifer Rabbitts","Professor, Department of Anesthesiology, Perioperative, and Pain Medicine",[62],{"name":63,"class":64},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH","100523273","studying-melatonin-and-recovery-in-teens-100523273",false,"NCT06093477","Studying Melatonin and Recovery in Teens","SurgerySMART: Studying Melatonin and Recovery in Teens","SurgerySMART","Inclusion Criteria:\n\nPatients\u002Fyouth:\n\n* Age 12-18 years\n* Participants undergoing elective major musculoskeletal surgery for eligible conditions\n* California state resident\n* Regular access to internet and smartphone\n* Can read and understand English or Spanish\n\nParents\u002Fcaregivers\n\n* Biological parent or legal guardian of youth\n* Can read and understand English or Spanish\n\nExclusion Criteria:\n\nPatients\u002Fyouth\n\n* Prescription medication for premorbid insomnia\n* Cognitive impairment or developmental delay\n* Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication\n* High risk for sleep related breathing disorder\n* Chronic medical condition that is severe\u002Fsystemic or requires regular treatment regimen\n* Psychiatric admission in prior 30 days\n* Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery\n* BMI ≥ 99th percentile\n* Enrollment in another therapeutic study\n* Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient's participation in the study","ALL","12 Years","18 Years",{"count":77,"type":78},45,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.",[84,85,86,87,88,89,90,91],"Juvenile; Scoliosis","Scoliosis Idiopathic","Scoliosis; Adolescence","Scoliosis;Congenital","Kyphosis","Spondylolisthesis","Pectus Surgery","Hip Surgery",[93,94,95,96,97,98,99,100,101,102,103,104,105,106],"sleep","pain medicine","pediatric pain medicine","melatonin","pilot feasibility trial","acute pain","chronic pain","CPSP","chronic postsurgical pain","spinal fusion surgery","adolescent","perioperative melatonin","hip surgery","pectus surgery","2026-03-16",{"date":109,"type":110},"2026-03-18","ACTUAL",{"date":112,"type":110},"2024-05-30",{"date":114,"type":78},"2028-03-31",{"name":5,"class":6},1]