[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100328760":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":34,"studyPopulation":21,"armGroups":35,"interventions":50,"overallOfficials":54,"centralContacts":59,"locations":67,"responsibleParty":88,"collaborators":21,"id":90,"slug":21,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":21,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":21,"enrollmentInfo":99,"targetDuration":21,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Carmel Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Pain assessment change","Pain assessment on a visual analogue scale","Change from pre- (1 hour before) to post-operative (24 hours following surgery)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Anxiety assessment change","Anxiety assessment on a visual analogue scale",{"measure":18,"description":19,"timeFrame":20},"Reduced analgesics use","Monitoring intra- and post-operative analgesia use","During surgery (4-6 hours) and 24-hour post-surgery",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Two main arms of control and intervention. Intervention arm include two sub-arms of integrative treatment plus acupuncture vs. integrative treatment with no acupuncture","SUPPORTIVE_CARE",{"masking":28,"maskingDescription":29,"whoMasked":30},"TRIPLE","Participant, care provider, and investigator are blind to allocation to control vs. intervention groups. Participant is also blind to the 2nd allocation to the two intervention group sub-arms.",[31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness. Following operation, pain and other quality of life-related concerns further exacerbate the emotional distress, which may itself aggravate pain and other symptoms. Clinical, controlled studied among patients with gynecological cancer undergoing chemotherapy had demonstrated effectiveness of complementary and integrative medicine (CIM) treatments for improving quality of life (QOL) and related symptoms, such as pain, gastro-intestinal concerns, fatigue, and anxiety.\n\nThe purpose of the proposed study is to explore the impact of CIM treatments (including acupuncture) on anxiety, pain, and general QOL of patients referred to gynecological oncology surgery. The investigators' working hypothesis is that an intensive CIM treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.",[36,40,46],{"label":37,"type":38,"description":39,"interventionNames":21},"Control","NO_INTERVENTION","Control group include participants randomly allocated to supportive care (with no added integrative care or acupuncture)",{"label":41,"type":42,"description":43,"interventionNames":44},"Touch\u002Frelaxation","EXPERIMENTAL","Touch\u002Frelaxation treatment (pre-operative)",[45],"Other: Acupuncture and touch\u002Frelaxation",{"label":47,"type":42,"description":48,"interventionNames":49},"Acupuncture and touch\u002Frelaxation","Acupuncture (intra operative) and touch-relaxation treatment (pre-operative)",[45],[51],{"type":6,"name":47,"description":52,"armGroupLabels":53,"otherNames":21},"Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture",[47,41],[55],{"name":56,"affiliation":57,"role":58},"Eran Ben-Arye, MD","Clalit Health Services","PRINCIPAL_INVESTIGATOR",[60,64],{"name":56,"role":61,"phone":62,"phoneExt":21,"email":63},"CONTACT","0528709282","eranben@netvision.net.il",{"name":65,"role":61,"phone":21,"phoneExt":21,"email":66},"Ofer Lavi, MD","lavi_ofer@clalit.org.il",[68],{"facility":69,"status":70,"city":71,"state":21,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Carmel Medical center","RECRUITING","Haifa","35152","Israel","IL",{"type":76,"coordinates":77},"Point",[78,79],34.99928,32.81303,{"lat":79,"lon":78},[82,86],{"name":56,"role":61,"phone":83,"phoneExt":84,"email":85},"972528709282","0","eranbe@clalit.org.il",{"name":87,"role":58,"phone":21,"phoneExt":21,"email":21},"Eran Ben-Arye",{"type":58,"investigatorFullName":87,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Clinical Associate Professor","100328760",false,"NCT03560388","Acupuncture and Integrative Care in Gynecological Surgery","Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Peri- and Intra-operative Pain and Anxiety in Patients With Gynecological Cancer: A Randomized Controlled Study","Inclusion Criteria: Female patients age ≥ 18 years, who were referred to surgery for suspected\u002Festablished gynecological-oncology cancer at the Carmel Medical Center; Patients diagnosed with class1-3 peri-operative risk according to American Society of Anesthesia.\n\nExclusion Criteria:Unwillingness to sign the research participation form and\u002For limitations in comprehending the informed consent; during pregnancy; patients with chronic pain treated with opiates within one month preceding surgery.",true,"FEMALE","18 Years",{"count":100,"type":101},135,"ESTIMATED","INTERVENTIONAL",[104],"NA","Patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness.The purpose of the proposed study is to explore the impact of complementary and integrative medicine (CIM) treatments (including acupuncture) on anxiety, pain, and general QOL of patients referred to gynecological oncology surgery. The investigators working hypothesis is that an intensive CIM treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.",[107],"Quality of Life",[109,110,111,112,113,114,115],"Integrative medicine","Acupuncture","Gynecological oncology","Surgery","Analgesia","Pain","Anxiety","2024-08-20",{"date":118,"type":119},"2024-08-21","ACTUAL",{"date":121,"type":119},"2018-06-24",{"date":123,"type":101},"2025-12-01",{"name":5,"class":6},1]