[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654377":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":39,"studyPopulation":39,"armGroups":47,"interventions":70,"overallOfficials":39,"centralContacts":92,"locations":98,"responsibleParty":111,"collaborators":39,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":39,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":39,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":39,"overallStatus":132,"whyStopped":39,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"the score of Hamilton anxiety rating scale, HAMA","This scale consists of 14 items. Trained physicians or assessors conduct a semi-structured interview to rate the subject's recent anxiety symptoms. The items cover two major dimensions: psychic anxiety (e.g., tension, fear) and somatic anxiety (e.g., muscle tension, cardiovascular symptoms).A higher score indicates more severe symptoms, with 7 set as the cut-off value.","week 0, week 4, week 8 and week 16 after enrollment",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"the score of Zung self-rating anxiety scale, SAS","This rating scale contains 20 items, and subjects complete the self-assessment independently without external interference. The standard score ranges from 25 to 100. A higher SAS score indicates more severe symptoms, with 53 set as the cut-off value.",{"measure":18,"description":19,"timeFrame":12},"the score of Pittsburgh sleep quality index, PSQI","PSQI is commonly used to assess the sleep quality of participants over the past month. The total score ranges from 0 to 21. A higher PSQI score indicates poorer sleep quality, with a cut-off value of 7.",{"measure":21,"description":22,"timeFrame":12},"the score of Short form-12 health survey, SF-12","This scale consists of 12 items, which is used to evaluate the recent health status of subjects, covering dimensions including physical function, pain, vitality, and social function. A higher score indicates better health status, and a standard score below 50 indicates that the health status is below the average level.",[24,28,32],{"measure":25,"description":26,"timeFrame":27},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","Details of all adverse events will be recorded on the Case Report Form (CRF). Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after the completion of the trial.","From enrollment to the end of treatment at 4 weeks",{"measure":29,"description":30,"timeFrame":31},"acupuncture compliance rate","At the end of the acupuncture intervention (end of week 4), compliance will be evaluated with the formula: Compliance Rate = (actual treatment times\u002Ftotal treatment times) \\*100%.","4 weeks after treatment",{"measure":33,"description":34,"timeFrame":35},"the level of Heart Rate Variability","After obtaining the consent of the subjects, the level of Heart Rate Variability data will be collected before and after the intervention to further explore the anti - anxiety mechanism of electroacupuncture.","week 0 and week 6 after enrollment",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":39,"timePerspective":39,"maskingInfo":41},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":42,"maskingDescription":39,"whoMasked":43},"TRIPLE",[44,45,46],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[48,55,61,66],{"label":49,"type":50,"description":51,"interventionNames":52},"sham electroacupuncture group (SEA group)","SHAM_COMPARATOR","In the SEA group, shallow punctures were made at the points 1 cm outward\u002Fradially from bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6), and Sishencong (EX-HN1) respectively, and then the power was cut off after connecting the electro - acupuncture device.Each treatment lasts 30 minutes, with 3 treatments per week for 4 consecutive weeks, totaling 12 treatments.",[53,54],"Device: sham electro-acupuncture","Other: manual acupuncture",{"label":56,"type":57,"description":58,"interventionNames":59},"2Hz continuous wave electroacupuncture group (2Hz EA group)","EXPERIMENTAL","Needles are routinely inserted at bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electroacupuncture is applied to bilateral Shenmen-Neiguan pairs, with intensity adjusted to subject tolerance, and frequencies of 2Hz. 30 minutes per session, 3 sessions weekly for 4 consecutive weeks, 12 sessions total.",[60,54],"Device: 2Hz electro-acupuncture",{"label":62,"type":57,"description":63,"interventionNames":64},"100Hz continuous wave electroacupuncture group (100Hz EA group)","Needles are routinely inserted at bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electroacupuncture is applied to bilateral Shenmen-Neiguan pairs, with intensity adjusted to subject tolerance, and frequencies of 100Hz. 30 minutes per session, 3 sessions weekly for 4 consecutive weeks, 12 sessions total.",[65,54],"Device: 100Hz electro-acupuncture",{"label":67,"type":57,"description":63,"interventionNames":68},"2Hz\u002F100Hz dense-disperse wave electroacupuncture group (2Hz\u002F100Hz EA group)",[69,54],"Device: 2Hz\u002F100Hz electro-acupuncture",[71,76,80,84,88],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":39},"DEVICE","sham electro-acupuncture","After connecting the electro - acupuncture device, the power was cut off for 30 minutes each time.Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.",[49],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":39},"2Hz electro-acupuncture","Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 2Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.",[56],{"type":72,"name":81,"description":82,"armGroupLabels":83,"otherNames":39},"100Hz electro-acupuncture","Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 100Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.",[62],{"type":72,"name":85,"description":86,"armGroupLabels":87,"otherNames":39},"2Hz\u002F100Hz electro-acupuncture","Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 2Hz\u002F100Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.",[67],{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":39},"manual acupuncture","Needles with a specification of 0.25×25mm were selected. Manual acupuncture is performed at the acupoints of Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1).",[62,56,67,49],[93],{"name":94,"role":95,"phone":96,"phoneExt":39,"email":97},"Xiaoting Wu, Doctor","CONTACT","+8618196671636","xiaotwu@163.com",[99],{"facility":100,"status":39,"city":101,"state":102,"zip":39,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":39},"2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","Hangzhou","Zhejiang","China","CN",{"type":106,"coordinates":107},"Point",[108,109],120.16142,30.29365,{"lat":109,"lon":108},{"type":112,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100654377","acupuncture-for-generalized-anxiety-disorder-100654377",false,"NCT07798986","Acupuncture for Generalized Anxiety Disorder","Efficacy of Different Electroacupuncture Parameters for Generalized Anxiety Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\nOnly those who meet the following four criteria simultaneously can be included in this study:\n\n1. Meet the diagnostic criteria for GAD;\n2. Between 18 and 60 years old;\n3. Conscious and able to communicate normally;\n4. Have good compliance, be willing to cooperate with the study, and sign the informed consent form.\n\nExclusion Criteria:\n\nExclude patients meeting any of the following criteria:\n\n1. Organic mental disorder, schizophrenia, bipolar disorder, mania\u002Fother psychoses, alcohol\u002Fdrug addiction, current drug use disorder\u002Flifetime drug abuse, post-stroke\u002Fpostpartum anxiety;\n2. History of suicidal behavior or severe suicidal tendency;\n3. Pregnancy or breastfeeding;\n4. Mental retardation, unable to cooperate;\n5. Electroacupuncture contraindications: bleeding tendency, coagulation dysfunction, internal metal implants;\n6. Participation in other clinical trials within 1 month.","ALL","18 Years","60 Years",{"count":124,"type":125},120,"ESTIMATED","INTERVENTIONAL",[128],"NA","Generalized anxiety disorder (GAD) is a common mental disorder characterized by persistent excessive worry, which seriously affects patients' quality of life. Electroacupuncture (EA) has been widely used in the clinical treatment of anxiety disorders, but the optimal stimulation parameters remain unclear. This study will adopt a randomized controlled trial (RCT) design to systematically compare the clinical efficacy of three different EA stimulation parameters (2 Hz continuous wave, 100 Hz continuous wave, and 2 Hz\u002F100 Hz dense-disperse wave) in patients with GAD. Multidimensional outcome assessment tools will be used to comprehensively evaluate the therapeutic effects of different stimulation modes. The results of this study are expected to provide evidence-based reference for the selection of electroacupuncture parameters in the treatment of GAD, so as to optimize the clinical treatment regimen and improve the therapeutic effect.",[131],"Generalized Anxiety Disorder (GAD)","NOT_YET_RECRUITING","2026-08-31",{"date":135,"type":136},"2026-09-02","ACTUAL",{"date":138,"type":125},"2026-09-01",{"date":140,"type":125},"2028-12-31",{"name":5,"class":6},1]