[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576304":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy",[13],"Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","SHAM_COMPARATOR","The sham electroacupuncture and paracetamol intravenous therapy",[19],"Device: The sham electroacupuncture and paracetamol intravenous therapy",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle insertion was performed perpendicularly at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture uses continuous waves of 2 Hz frequency with an intensity that can be tolerated by the patient for 30 minutes.\n\nPatients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Sham electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle only attached using plester (not inserted) at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture device is not turned on. The therapy is carried out for 30 minutes.\n\nPatients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.",[15],[30],{"name":31,"affiliation":32,"role":33},"KPEK FKUI-RSCM","The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Hermin Widyaprastuti, MD","CONTACT","+6281286190436","widyaprastuti.hermin1@gmail.com",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Universitas Indonesia","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":49,"coordinates":50},"Point",[51,52],106.8223,-6.1818,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":25,"email":57},"Hermin Widyaprastuti","hermin.widyaprastuti1@gmail.com",{"type":33,"investigatorFullName":56,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Medical Doctor","100576304","the-analgesia-effect-of-electroacupuncture-battlefield-acupuncture-versus-sham-electroakupuncture-post-surgery-100576304",false,"NCT06783556","The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery","The Analgesia Effect of Electroacupuncture of Battlefield Acupuncture (BFA) Versus Sham Electroacupuncture on Pain, Analgesic Dose Reduction and Quality of Life Post Percutaneous Nephrolithotomy Surgery","Inclusion Criteria:\n\n* Men or women aged 18-65 years\n* Patients who have been diagnosed with kidney stones measuring \\> 2 cm and will undergo PCNL surgery\n* VAS score \\\u003C7, assessed 2 hours before PCNL surgery\n* Receive standard analgesic therapy\n* Willing to participate in this study until completion and sign an informed consent.\n\nExclusion Criteria:\n\n* Kidney anatomical abnormalities\n* Ear deformities (microtia)\n* Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)\n* Tumors, wounds or skin infections in the needling area.\n* Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.\n* Allergy to acupuncture needles or certain metals\n* Patients who have had a DJ stent or nephrostomy before PCNL\n* History of metal implants in the body except amalgam","ALL","18 Years","65 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are:\n\n* Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n* Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n* Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n\nResearchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups.\n\nParticipants will:\n\n* Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes\n* Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups",[78],"Percutaneous Nephrolithotomy","NOT_YET_RECRUITING","2025-01-18",{"date":82,"type":83},"2025-01-22","ACTUAL",{"date":85,"type":72},"2025-01-20",{"date":87,"type":72},"2025-06-01",{"name":5,"class":6},1]