[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653710":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":47,"studyPopulation":37,"armGroups":48,"interventions":60,"overallOfficials":37,"centralContacts":70,"locations":76,"responsibleParty":92,"collaborators":37,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":37,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":37,"enrollmentInfo":103,"targetDuration":37,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":37,"overallStatus":112,"whyStopped":37,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"General Hospital of Ningxia Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of skin redness (blanching erythema) at end of surgery","Number (%) of participants with pressure-induced skin redness (defined as blanching on 3-second fingertip pressure) at dependent sites (sacrum, ASIS, external malleolus, axilla, rib margin, lateral knee) assessed by trained researcher at operative end.","At end of operation",[14,17,21,25,29,33],{"measure":15,"description":16,"timeFrame":12},"Incidence of Stage I pressure injury (NPUAP) at end of surgery","Number (%) per NPUAP staging",{"measure":18,"description":19,"timeFrame":20},"Shoulder traction pain VAS at 24 h postop","Visual analogue scale(VAS) 0-10 (0 none, 1-3 mild, 4-6 moderate, 7-10 severe); reported as median (Q1, Q3)","24 hours after surgery",{"measure":22,"description":23,"timeFrame":24},"Positioning time (minutes)","From command \"turn\" to circulating nurse sign-off; mean ± SD","Intraoperative, single time point",{"measure":26,"description":27,"timeFrame":28},"Healthcare worker satisfaction with positioning method","3-level scale (very satisfied \u002F satisfied \u002F unsatisfied) for surgeons, anesthesiologists, circulating nurses; reported as count (%)","Immediately after positioning",{"measure":30,"description":31,"timeFrame":32},"CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment)","Assessed using the Chinese Operating Room Nurse (CORN) intraoperative acquired pressure injury risk scale (preoperative dimension, 6 items: ASA class, BMI, skin status, limb mobility, planned operative duration, diabetes). Range 6-24; higher score indicates higher risk. Evaluated once at enrollment.","On enrollment, immediately before anesthesia induction (preoperative)",{"measure":34,"description":35,"timeFrame":36},"CORN Intraoperative Acquired Pressure Injury Risk Score (Intraoperative Dynamic Assessment)","Assessed using the CORN scale intraoperative dimension (4 items: body temperature loss factor, blood loss volume, pressure\u002Fshear change, actual operative duration). Range 4-16; higher score indicates higher risk. Evaluated once at end of surgery before leaving operating room.","At end of surgery, before transfer out of operating room (intraoperative)",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","This is a single-blind, parallel-group, randomized controlled trial. Due to the nature of the procedural intervention, care providers and outcome assessors cannot be blinded to the group allocation. However, participants are blinded, as all positioning procedures are performed after the induction of general anesthesia and before the surgical incision, ensuring that patients have no awareness of whether they received the modified or conventional positioning protocol.","PREVENTION",{"masking":44,"maskingDescription":37,"whoMasked":45},"SINGLE",[46],"PARTICIPANT","This is a randomized, single-blind, parallel-group controlled trial conducted at the Department of Anesthesiology and Perioperative Medicine, General Hospital of Ningxia Medical University. The study aims to evaluate the efficacy of a modified lateral decubitus positioning protocol in reducing intraoperative pressure injuries and postoperative shoulder traction pain among patients undergoing elective neurosurgical procedures under general anesthesia.\n\nStudy Design and Masking:\n\nPatients are randomly assigned to either the experimental group (modified positioning protocol) or the control group (conventional positioning protocol). Participants are blinded to their group allocation, as all positioning procedures are performed after the induction of general anesthesia and before surgical incision. However, due to the nature of the procedural intervention, operating room staff (care providers) and outcome assessors cannot be blinded to the group allocation.\n\nInterventions:\n\nExperimental Group: Patients receive a modified positioning protocol utilizing an L-shaped one-piece arm board for dependent arm suspension and a funnel-shaped adhesive film for shoulder fixation at a 45-degree angle. This approach aims to optimize pressure redistribution and reduce nerve traction.\n\nControl Group: Patients receive the standard traditional lateral decubitus positioning method routinely used in clinical practice, involving axillary rolls, manual shoulder taping, and sequential placement of support pads.\n\nProcedures and Assessments:\n\nUpon obtaining informed consent, baseline data including the CORN (Chinese Operating Room Nurse) intraoperative pressure injury risk score are collected. During the procedure, positioning time is recorded from the command to turn the patient to the circulating nurse's final confirmation. Postoperatively, the incidence of skin erythema and Stage I pressure injuries (assessed via NPUAP criteria) is documented. Shoulder traction pain is evaluated at 24 hours postoperatively using the Visual Analog Scale (VAS). Additionally, satisfaction levels regarding the positioning method are surveyed among surgeons, anesthesiologists, and circulating nurses.\n\nObjective:\n\nThis study seeks to establish an evidence-based, ergonomic positioning standard that enhances patient safety and comfort while improving workflow efficiency for the surgical team.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Modified Positioning Protocol (Group M)","EXPERIMENTAL","After anesthetic induction, patient transferred from stretcher to OR table; 90° roll; dependent acromion aligned with headboard; dependent arm suspended on L-shaped one-piece arm board; operative-side arm hangs naturally; funnel-shaped medical adhesive film replaces shoulder tape, pulled 45° toward foot along sagittal plane, covering deltoid\u002Fpectoralis\u002Ftrapezius; dependent leg extended, upper leg flexed on molded fluid pad; pelvic rest at pubic symphysis and sacrum; head fixed after headboard removed. Fluid pad pre-molded before induction.",[54],"Procedure: Modified Lateral Decubitus Positioning Protocol",{"label":56,"type":6,"description":57,"interventionNames":58},"Traditional Positioning Protocol (Group T)","Axillary roll, iliac crest roll, leg pad placed sequentially; dependent arm extended on table-side hand board, upper arm flexed to chest; running posture for legs; pelvic frame fixed; shoulder taped with cotton band and pulled distally; knee restrained with strap.",[59],"Procedure: Conventional Lateral Decubitus Positioning",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":37},"PROCEDURE","Modified Lateral Decubitus Positioning Protocol","Patients receive a modified lateral decubitus positioning protocol utilizing an L-shaped one-piece arm board for dependent arm suspension and a funnel-shaped adhesive film for shoulder fixation at a 45-degree angle. This approach aims to optimize pressure redistribution and reduce nerve traction during neurosurgical procedures under general anesthesia. Positioning is performed after induction of anesthesia and before surgical incision.",[50],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":37},"Conventional Lateral Decubitus Positioning","Patients receive the standard traditional lateral decubitus positioning method routinely used in clinical practice, including axillary rolls, manual shoulder taping, and sequential placement of support pads. No specialized arm board or adhesive fixation is used.",[56],[71],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},"Liwei Huang","CONTACT","86-951-674-5913","huangliwei520@126.com",[77],{"facility":78,"status":37,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"General hospital of Ningxia medical university","Yinchuan","Ningxia","750004","China","CN",{"type":85,"coordinates":86},"Point",[87,88],106.27306,38.46806,{"lat":88,"lon":87},[91],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},{"type":93,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100653710","effect-of-positioning-protocol-on-skin-pressure-injury-and-shoulder-traction-pain-in-neurosurgical-patients-100653710",false,"NCT07791056","Effect of Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients","Effect of Modified Lateral Decubitus Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Elective neurosurgical procedure under general anesthesia\n* Planned surgical position: lateral decubitus\n* Expected operative duration ≥ 2 hours (from completion of positioning to end of surgery)\n\nExclusion Criteria:\n\n* Pre-existing skin injury before surgery\n* Acute or chronic skin disease\n* Communication disorder \u002F inability to express pain verbally\n* Severe cardiac, hepatic, or renal disease\n\nWithdrawal Criteria:\n\n* Intraoperative change of surgical position from lateral decubitus to another position due to unexpected surgical requirements\n* Intraoperative hemodynamic instability or other critical events requiring immediate repositioning or termination of the procedure\n* Inability to complete the 24-hour postoperative follow-up assessment (e.g., transfer to ICU, unplanned reoperation, or death)\n* Development of a serious adverse event directly attributable to the positioning procedure that necessitates discontinuation of the assigned protocol","ALL","18 Years",{"count":104,"type":105},80,"ESTIMATED","INTERVENTIONAL",[108],"NA","This study evaluates a modified lateral decubitus positioning method designed to prevent pressure injuries and reduce shoulder traction pain in patients undergoing neurosurgical procedures under general anesthesia. Participants will be randomly assigned to either the modified positioning group or the conventional positioning group. The main goal is to compare the incidence of Stage I pressure injuries (per NPUAP criteria) at the end of surgery and the severity of shoulder pain (measured by VAS) at 24 hours postoperatively. Secondary outcomes include positioning time, healthcare worker satisfaction, and changes in CORN intraoperative pressure injury risk scores. This research aims to provide evidence-based guidance for optimizing intraoperative nursing care and improving patient safety and comfort in the operating room.",[111],"Pressure Injuries","NOT_YET_RECRUITING","2026-08-24",{"date":115,"type":116},"2026-08-27","ACTUAL",{"date":118,"type":105},"2026-09-01",{"date":120,"type":105},"2026-12-01",{"name":5,"class":6},1]