protocolSection identificationModule nctId: NCT06365892, orgStudyIdInfo id: 22-36548, briefTitle: Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years., conditionsModule conditions: Adolescent Idiopathic Scoliosis (AIS), designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding of patients and providers will not be feasible due to the nature of the study., enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: open-label placebo, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery, secondaryOutcomes measure: Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6., secondaryOutcomes measure: Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6., secondaryOutcomes measure: Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6., secondaryOutcomes measure: The duration of time in days following surgery until patients establish Independence with Physical Therapy, secondaryOutcomes measure: The length of time in days following surgery until discharge from the hospital, secondaryOutcomes measure: The length of time in days following surgery until participant returns to school, secondaryOutcomes measure: Whether participants experience urinary retention following surgery., secondaryOutcomes measure: Whether participants experience constipation measured by the number of days between surgery and first bowel movement, secondaryOutcomes measure: Whether participants experience an oxygen requirement and the duration of the requirement following surgery., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False