[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proximal-humerus-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proximal-humerus-fractures":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100624919","assessing-the-functional-benefit-of-structured-psychological-coaching-in-mentally-vulnerable-patients-with-a-surgically-treated-proximal-humerus-fracture-100624919",false,"NCT07415889","Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.","ELEVATE","Inclusion Criteria:\n\n1. Surgically treated proximal humerus fracture, not older than two weeks\n2. A high or very high level of neuroticism (cut-off score on NEO-FFI test off 37)\n3. Minimal age of 18 years\n4. The fracture must be a mono-injury (not part of a multi-injury incident)\n\nExclusion Criteria:\n\n1. Any diagnosed psychiatric disorder that is not adequately managed with medication.\n2. Not being able to communicate: language barrier, neurologic disorders\n3. Paralysis on the affected arm\n4. Not able to participate in online or real time psychological training\n5. Any other fracture besides the proximal humerus fracture in an upper extremity\n6. Head trauma with neurological symptoms","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","Although physical factors play an important role in the treatment and outcomes after proximal humerus fracture (PHF), psychosocial factors need to be taken into account as well.\n\nFew studies have been done to assess the influence of psychosocial factors and mental distress on the outcomes after shoulder surgery and show that it has a negative correlation on the outcomes. It is reported that having low resilience, negative thoughts, signs of depression or anxiety have a significant negative relation with the patient reported outcomes (PROMs).\n\nMental vulnerability is linked to neuroticism, a personality factor of the Big Five traits, that can be characterized by the tendency to experience negative affect, especially when threatened, frustrated, or facing loss. Neuroticism is related to worse outcomes of health and disease in patients. Although studies have been done to objectify the correlation between psychological factors and functional outcomes after surgery there has not yet been a trial where an intervention has taken place to improve functional outcomes when patients have neurotic tendencies. With this study, we aim to improve the functional outcomes for patients with neuroticism and proximal humerus fractures undergoing surgery by giving them psychological training in the form of focused cognitive behavioral therapy additionally to the standard care. Psychological treatment has shown to improve the well-being of the 'patient characteristics associated with neuroticism and reduce rumination and worry.\n\nTherefore, we hypothesize that providing psychological guidance, consisting of a focused cognitive behavioral therapy program, to patients with neuroticism after a PHF will lead to better patient related outcomes.",[26,27],"Proximal Humerus Fractures","Neuroticism",[27,29,30,31,32],"Proximal humerus fracture","Shoulder","Cognitive behavioral therapy","Surgery","RECRUITING","2026-02-09",{"date":36,"type":37},"2026-02-17","ACTUAL",{"date":39,"type":37},"2025-12-02",{"date":41,"type":20},"2027-12",{"name":43,"class":44},"Zaandam Medical Center","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":79,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100522111","opioid-free-pain-treatment-in-trauma-patients-100522111","NCT06078371","Opioid-Free Pain Treatment in Trauma Patients","Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Patient is over the age of 18 years old\n* Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital\n\nExclusion Criteria:\n\n* Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury\n* Chronic opioid use\n* Under the age of 18 years old\n* Undergoing revision surgery\n* Did not undergo surgical fixation\n* Pregnant\u002Fnursing women\n* Vulnerable populations as defined by the University of Kansas Medical Center IRB\n* Did not experience one of the following fractures listed in D.1. above.\n* Patients with CKD and\u002For cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)",{"count":54,"type":20},250,[23],"Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,26,72,73,74,75,76,77,78],"Femoral Neck Fractures","Intertrochanteric Fractures","Femoral Shaft Fracture","Distal Femur Fracture","Patella Fracture","Tibial Shaft Fracture with or Without Associated Fibula Fracture","Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)","Tibial Pilon Fracture","Talar Head, Neck, Body, or Process Fractures","Calcaneus Fractures","Lisfranc Injuries","Isolated or Multiple Metatarsal Fractures","Phalanx Fractures of the Foot, Single or Multiple","Clavicle Fractures","Humeral Shaft Fractures","Distal Humerus Fractures (intra or Extra-articular)","Olecranon Fractures","Radial Head or Neck Fractures","Elbow Fractures Involving a Combination of Fractures of the Radius and Uln","Forearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)","Distal Radius Fractures",[80,81],"Surgical Intervention","Trauma","2024-10-22",{"date":84,"type":37},"2024-10-26",{"date":86,"type":37},"2023-11-01",{"date":88,"type":20},"2026-10",{"name":90,"class":44},"University of Kansas Medical Center",1]