[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06054802":3,"trial-entities:NCT06054802":77,"trial-summary:NCT06054802":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":60,"locations":63,"central_contacts":73,"overall_officials":74,"references":75,"see_also_links":76},"NCT06054802","STUDY00003629","Perioperative Sleep Quality and Postoperative Pain Outcomes","The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery","ENROLLING_BY_INVITATION","2027-12","2026-03","2026-04-06","2025-02-03","Grant Heydinger","OTHER",false,"This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.",null,[19,20,21,22],"Surgery","Pain","Sleep","Spinal Fusion",[],"OBSERVATIONAL",[],{"count":27,"type":28},166,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","eCAP","eCap™ has the look and feel of a regular prescription bottle and records real-time adherence data, tracking each opening with the date and time.",[35],"PSF",[37,41],{"measure":38,"description":39,"timeFrame":40},"Pittsburgh Sleep Quality Index","Pittsburgh Sleep Quality Index (PSQI) is a validated, self-report questionnaire that assesses sleep quality over a one-month period that takes five to ten minutes to complete. It offers seven component scores (e.g., subjective sleep quality, latency, duration, and efficiency) as well as a composite score that measures overall sleep quality. A total score greater than five yields a sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p \\\u003C0.001) in distinguishing good from poor sleepers.","Baseline",{"measure":42,"description":43,"timeFrame":44},"Difference in opioid consumption between self-report and eCap","The eCAP Electronic Content Monitor (ECM) is a smart pill bottle used to monitor and improve medication adherence. When opened, an event is recorded, and the data is securely stored. The eCAP device timestamps medication usage and provides a visualization demonstrating how patients are taking medications, providing robust analytics. Subjects will also record each time they take an opioid pain medicine on a daily diary.","Days 1-14 post-op",[],"ALL","10 Years","18 Years",{"inclusion":50,"exclusion":54,"raw_text":59},[51,52,53],"able to read, understand, and speak English","are undergoing posterior spinal fusion surgery","have availability of a mobile device\u002Fcomputer to receive text messages",[55,56,57,58],"\\\u003C 10 or \\> 18 years of age","have a history of sleep-disordered breathing including sleep apnea","have a history of chronic pain or current opioid use","have a history of developmental delay that would preclude study participation","Inclusion Criteria:\n\n* able to read, understand, and speak English\n* are undergoing posterior spinal fusion surgery\n* have availability of a mobile device\u002Fcomputer to receive text messages\n\nExclusion Criteria:\n\n* \\\u003C 10 or \\> 18 years of age\n* have a history of sleep-disordered breathing including sleep apnea\n* have a history of chronic pain or current opioid use\n* have a history of developmental delay that would preclude study participation",[61,62],"CHILD","ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"Nationwide Children's Hospital","Columbus","Ohio","43205","United States",{"lat":71,"lon":72},39.96118,-82.99879,[],[],[],[],{"nct_id":4,"conditions":78,"biomarkers":79},[22],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]