[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100363639":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":100,"centralContacts":104,"locations":114,"responsibleParty":128,"collaborators":10,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":10,"studyType":145,"phases":10,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":116,"whyStopped":10,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",[8,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group for CPHP",null,"Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if no significant pain is noted during the follow up evaluations at 4 and 6 months.",[13,14,15,16,17,18,19,20,21,22,23],"Diagnostic Test: Pain-Pressure Threshold","Diagnostic Test: Mechanical Temporal Summation","Diagnostic Test: Hospital Anxiety and Depression Scale","Diagnostic Test: Pain Catastrophizing Scale","Diagnostic Test: Central Sensitization Inventory","Diagnostic Test: Fear-Avoidance Component Score","Diagnostic Test: EQ-5D","Diagnostic Test: heart rate variability","Diagnostic Test: Anxiety, anticipated pain, anticipated analgesia","Diagnostic Test: State-trait anxiety inventory","Diagnostic Test: Beck's Depression Inventory",{"label":25,"type":10,"description":26,"interventionNames":27},"Chronic Post-Hysterectomy Pain (CPHP)","Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if significant pain is noted during the follow up evaluations at 4 and 6 months.",[13,14,15,16,17,18,19,20,21,22,23],{"label":29,"type":10,"description":30,"interventionNames":31},"Control group for significant postoperative pain","Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if no significant pain is noted during the follow up evaluations at 24 and 48 hours.",[13,14,15,16,17,18,19,20,21,22,23],{"label":33,"type":10,"description":34,"interventionNames":35},"Significant postoperative pain","Preoperative assessment with questionnaires, Mechanical Temporal Summation, Pain-Pressure Threshold, and heart rate variability. All patients will undergo elective abdominal or laparoscopic hysterectomy. Patients will be assigned to this group if significant pain is noted during the follow up evaluations at 24 and 48 hours.",[13,14,15,16,17,18,19,20,21,22,23],[37,44,50,56,62,68,74,78,84,88,94],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DIAGNOSTIC_TEST","Pain-Pressure Threshold","Performed on bilateral trapezius muscles. Pressure will be applied at 90 degrees downward with an algometer, with the speed of pressure increase approximately 1kgf\u002Fs. Upon the sensation of pain, the patient will vocalize or raise her hand to terminate the test, and the highest reading will be recorded (up to maximum 6kgf). If two values are recorded within 0.2kgf of each other, the mean value will be recorded. If two values are greater than 0.2kgf of each other, a third test will be performed and the mean obtained.",[25,9,29,33],[43],"PPT",{"type":38,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Mechanical Temporal Summation","Pinprick hyperalgesia will be evoked using a Von Frey filament, applied to the volar aspect of the dominant forearm. Participants will report using the numerical rating scale the intensity of pain from the first stimulus. Subsequently, ten repetitive stimuli one second apart will be applied with the same filament within an area of 1cm diameter of the same forearm. Subjects will report the rate the pain intensity of the tenth stimulus. The magnitude of MTS is calculated as the difference between the last to the first pain scores. The investigators will classify the participants according to \"evoked MTS\" if the last stimulus is rated higher than the first, or \"no MTS\" if the last stimulus is rated equal or lower than the first. The research team administering the test will follow a set script.",[25,9,29,33],[49],"MTS",{"type":38,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Hospital Anxiety and Depression Scale","Standardized questionnaire to determine the level of anxiety and depression.",[25,9,29,33],[55],"HADS",{"type":38,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Pain Catastrophizing Scale","Standardized questionnaire to determine the level of pain catastrophizing.",[25,9,29,33],[61],"PCS",{"type":38,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Central Sensitization Inventory","Standardized questionnaire to determine the level of central sensitization.",[25,9,29,33],[67],"CSI",{"type":38,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Fear-Avoidance Component Score","Standardized questionnaire to determine the level of fear and avoidance.",[25,9,29,33],[73],"FACS",{"type":38,"name":75,"description":76,"armGroupLabels":77,"otherNames":10},"EQ-5D","Standardized questionnaire to assess generic health-related quality of life.",[25,9,29,33],{"type":38,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"heart rate variability","Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.",[25,9,29,33],[83],"HRV",{"type":38,"name":85,"description":86,"armGroupLabels":87,"otherNames":10},"Anxiety, anticipated pain, anticipated analgesia","Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).",[25,9,29,33],{"type":38,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"State-trait anxiety inventory","Standardized questionnaire to assess anxiety.",[25,9,29,33],[93],"STAI",{"type":38,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"Beck's Depression Inventory","Standardized questionnaire to assess depressive symptoms.",[25,9,29,33],[99],"BDI",[101],{"name":102,"affiliation":5,"role":103},"Farida Ithnin, MBBS","PRINCIPAL_INVESTIGATOR",[105,110],{"name":106,"role":107,"phone":108,"phoneExt":10,"email":109},"Ban Leong Sng, MBBS","CONTACT","+65 6394 1077","sng.ban.leong@singhealth.com.sg",{"name":111,"role":107,"phone":112,"phoneExt":10,"email":113},"Hon Sen Tan, MD","+65 9365 7193","paul.tan.hs@singhealth.com.sg",[115],{"facility":5,"status":116,"city":117,"state":10,"zip":118,"country":117,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"RECRUITING","Singapore","229899","SG",{"type":121,"coordinates":122},"Point",[123,124],103.85007,1.28967,{"lat":124,"lon":123},[127],{"name":111,"role":107,"phone":10,"phoneExt":10,"email":113},{"type":129,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100363639","evaluation-of-central-sensitization-fear-avoidance-and-pain-pressure-threshold-with-chronic-pain-after-hysterectomy-100363639",false,"NCT04014829","Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy","Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain in Post-Hysterectomy Patients: A Collaborative Cohort Study (EPOCH - Enhancing Post-operative Outcomes in Chronic Pain After Hysterectomy)","EPOCH","Inclusion Criteria:\n\n* Age 21 to 80 years old\n* American Society of Anesthesiologists Physical Scale (ASA) I to III\n* Benign gynaecological indications for hysterectomy\n* Elective abdominal or laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* Vaginal hysterectomy\n* Uterine prolapse, endometriosis, malignant disease, or pelvic pain as main indication for surgery\n* History of drug dependence or recreational drug use\n* History of chronic pain syndrome\n* Current chronic daily treatment with corticosteroids, excluding inhaled steroids\n* Allergy to study drugs\n* Major heart surgery\n* Heart transplant\n* Pacemaker inserted\n* Baseline non-sinus cardiac rhythm",true,"FEMALE","21 Years","80 Years",{"count":143,"type":144},436,"ESTIMATED","OBSERVATIONAL","Phase 1 (started in July 2019):\n\nCentral Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively.\n\n===\n\nPhase 2 (anticipated start May 2022):\n\nIn addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated.",[148,149,150,151],"Hysterectomy","Chronic Pain","Central Sensitisation","Anxiety Depression",[148,149,153,154,39,45,155],"Fear-Avoidance","Central Sensitization","Heart rate variability","2024-11-24",{"date":158,"type":159},"2024-11-26","ACTUAL",{"date":161,"type":159},"2019-07-23",{"date":163,"type":144},"2027-12",{"name":5,"class":6},1]