[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652594":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":77,"studyPopulation":70,"armGroups":78,"interventions":89,"overallOfficials":95,"centralContacts":100,"locations":110,"responsibleParty":125,"collaborators":70,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":70,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":70,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":150,"whyStopped":70,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Holy Family Hospital, Nazareth, Israel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":70},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of Recovery-15 (QoR-15) total score","The Quality of Recovery-15 (QoR-15) is a validated 15-item patient-reported questionnaire that assesses postoperative recovery across five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 150, with higher scores indicating better postoperative recovery.","24 hours after cesarean delivery",[14,18,21,25,29,33,37,41,44,48,52,55,58,62,66],{"measure":15,"description":16,"timeFrame":17},"Postoperative pain intensity at rest","Pain intensity assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) while at rest.","2-4, 8-10, 24, and 48 hours after cesarean delivery",{"measure":19,"description":20,"timeFrame":17},"Postoperative pain intensity during movement","Pain intensity assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) after 2-3 minutes of walking.",{"measure":22,"description":23,"timeFrame":24},"Satisfaction with pain control","Patient satisfaction with postoperative pain management measured using an 11-point NRS ranging from 0 (not satisfied) to 10 (very satisfied).","24 and 48 hours after cesarean delivery",{"measure":26,"description":27,"timeFrame":28},"Total opioid consumption","Total rescue opioid use during the postoperative period, recorded as the number of tablets and total milligram dose.","Within 72 hours after cesarean delivery",{"measure":30,"description":31,"timeFrame":32},"Time to first bowel function","Time from surgery to first passage of flatus or bowel movement.","Within hospitalization (up to discharge, approximately 72 hours)",{"measure":34,"description":35,"timeFrame":36},"Postpartum fever","Occurrence of postpartum fever according to institutional diagnostic criteria.","During hospitalization (up to approximately 72 hours after surgery)",{"measure":38,"description":39,"timeFrame":40},"Endometritis","Occurrence of clinically diagnosed postpartum endometritis.","Perioperatively",{"measure":42,"description":43,"timeFrame":40},"Surgical site infection","Occurrence of surgical site infection diagnosed according to institutional criteria.",{"measure":45,"description":46,"timeFrame":47},"Change in hemoglobin concentration","Maximum difference between preoperative and postoperative hemoglobin levels","Within 24 hours after cesarean delivery",{"measure":49,"description":50,"timeFrame":51},"Heart rate","Maximum and minimum daily heart rate recorded during routine postoperative monitoring","Within the first 24 hours after cesarean delivery",{"measure":53,"description":54,"timeFrame":51},"Respiratory rate","Maximum and minimum daily respiratory rate recorded during routine postoperative monitoring",{"measure":56,"description":57,"timeFrame":40},"Time to first breastfeeding","Time from cesarean delivery to the first breastfeeding session.",{"measure":59,"description":60,"timeFrame":61},"Neonatal feeding method at discharge","Infant feeding method at hospital discharge (exclusive breastfeeding, mixed feeding, or formula feeding).","Up to one weeks",{"measure":63,"description":64,"timeFrame":65},"Length of hospital stay","Duration of hospitalization from cesarean delivery until discharge.","through study completion, an average of 4 days.",{"measure":67,"description":68,"timeFrame":69},"TENS-related adverse events","Occurrence of adverse events related to TENS use, including skin irritation, pain, burning sensation, or other device-related reactions.","During the 24-hour TENS intervention period",null,{"allocation":72,"interventionModel":73,"interventionModelDescription":70,"primaryPurpose":74,"observationalModel":70,"timePerspective":70,"maskingInfo":75},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":76,"maskingDescription":70,"whoMasked":70},"NONE","Cesarean delivery is one of the most commonly performed surgical procedures worldwide and is frequently associated with moderate to severe acute postoperative pain. Adequate pain control is particularly important following cesarean delivery because women must recover from major abdominal surgery while caring for and breastfeeding their newborns. Poorly controlled postoperative pain has been associated with delayed mobilization, impaired maternal-infant interaction, increased opioid consumption, chronic postsurgical pain, and postpartum depression. Although multimodal pharmacological analgesia is the standard approach for post-cesarean pain management, opioid analgesics may cause adverse maternal effects, including nausea, vomiting, sedation, and constipation, and there is increasing interest in adjunctive non-pharmacological interventions that may improve recovery while reducing opioid requirements.\n\nTranscutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, safe, and inexpensive modality that delivers low-voltage electrical stimulation through surface electrodes to reduce pain. Proposed mechanisms include modulation of nociceptive transmission through the gate control mechanism and stimulation of endogenous opioid release. Although previous systematic reviews suggest that TENS may reduce postoperative pain after cesarean delivery, the available evidence is limited by small sample sizes, methodological heterogeneity, and low certainty. Additional well-designed randomized controlled trials are needed to establish its clinical effectiveness.\n\nThis study is a single-center, randomized controlled trial designed to evaluate the effectiveness of continuous 24-hour TENS as an adjunct to standard postoperative analgesia in women undergoing cesarean delivery under spinal anesthesia. Eligible participants will be randomized in a 1:1 ratio to receive either continuous TENS therapy in addition to standard postoperative care or standard postoperative care alone. TENS treatment will be initiated within two hours after surgery and applied around the surgical incision using standardized electrode placement and stimulation parameters. Participants assigned to the intervention group will be encouraged to use the device continuously during the first 24 postoperative hours, with stimulation intensity adjusted according to individual comfort.\n\nAll participants will receive the same perioperative management, including standardized spinal anesthesia, local wound infiltration, postoperative analgesic regimen, and postoperative care according to departmental protocols. The primary outcome will be the Quality of Recovery-15 (QoR-15) score assessed 24 hours after cesarean delivery. Secondary outcomes will include postoperative pain intensity at rest and during movement, patient satisfaction with pain management, opioid consumption during the first 72 postoperative hours, time to bowel function recovery, maternal postoperative complications, breastfeeding outcomes, length of hospital stay, and adverse events related to TENS.\n\nThe study will enroll 196 participants, with sample size determined to detect a clinically meaningful difference in QoR-15 scores between groups. Analyses will be conducted according to the intention-to-treat principle. The findings of this trial will provide high-quality evidence regarding the effectiveness of continuous 24-hour TENS as an adjunctive strategy for improving postoperative recovery and pain management following cesarean delivery.",[79,85],{"label":80,"type":81,"description":82,"interventionNames":83},"TENS Group","EXPERIMENTAL","Patient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol.",[84],"Device: TENS",{"label":86,"type":87,"description":88,"interventionNames":70},"No-TENS Control Group","NO_INTERVENTION","Patients will receive the standard analgesic protocol only.",[90],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":70},"DEVICE","TENS","Participants randomized to the intervention group will receive continuous transcutaneous electrical nerve stimulation (TENS) in addition to standard postoperative analgesia. TENS will be initiated within 2 hours after cesarean delivery and applied continuously for the first 24 postoperative hours. Participants will be instructed to wear the device continuously and may temporarily remove the device for showering. All participants will receive in addition the institution's standard postoperative care and analgesic regimen following cesarean delivery.",[80],[96],{"name":97,"affiliation":98,"role":99},"Raed Salim","The Azrieli Faculty of Medicine, Bar Ilan University","STUDY_CHAIR",[101,106],{"name":102,"role":103,"phone":104,"phoneExt":70,"email":105},"Maysa Abboud, MD","CONTACT","972-509516904","abboudmaysa@gmail.com",{"name":107,"role":103,"phone":108,"phoneExt":70,"email":109},"Raed Salim, MD","0544986960","r.salim@hfhosp.org",[111],{"facility":112,"status":70,"city":113,"state":70,"zip":70,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Holy Family Hospital","Nazareth","Israel","IL",{"type":117,"coordinates":118},"Point",[119,120],35.29719,32.70087,{"lat":120,"lon":119},[123],{"name":124,"role":103,"phone":70,"phoneExt":70,"email":109},"Raed",{"type":126,"investigatorFullName":107,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":70,"oldOrganization":70},"PRINCIPAL_INVESTIGATOR","Professor","100652594","tens-use-for-post-cesarean-pain-management-100652594",false,"NCT07777939","TENS Use for Post-cesarean Pain Management","Continuous 24-Hour Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Management: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 18-45 years.\n* Undergoing CD under spinal anesthesia.\n* Hemodynamically stable postoperatively.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Undergoing CD under epidural or general anesthesia.\n* Skin lesions or infection at electrode placement sites.\n* Pacemaker or implanted electrical devices.\n* Neurological disorders affecting pain perception.\n* Chronic opioid use or chronic pain disorders.\n* Allergy or other contraindication to opioids, nonsteroidal antiinflammatory drugs, or acetaminophen use.\n* Adhesive allergy.\n* Midline vertical skin incision (in the current or previous cesarean).\n* Intraoperative sterilization.\n* Cesarean hysterectomy.","FEMALE","18 Years","45 Years",{"count":139,"type":140},196,"ESTIMATED","INTERVENTIONAL",[143],"NA","The aim of this randomized controlled trial is to evaluate the effectiveness of continuous 24-hour Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to standard postoperative care for pain management following cesarean delivery. Eligible women undergoing cesarean delivery under spinal anesthesia will be randomly assigned in a 1:1 ratio to either the intervention group, which will receive continuous TENS in addition to standard postoperative analgesia, or the control group, which will receive standard postoperative analgesia alone. The primary outcome is the Quality of Recovery-15 (QoR-15) score assessed 24 hours after cesarean delivery.",[146],"Post Cesarean Pain Management",[148,92,149],"Cesarean delivery","POSTPARTUM PAIN","NOT_YET_RECRUITING","2026-08-21",{"date":153,"type":154},"2026-08-24","ACTUAL",{"date":156,"type":140},"2026-08",{"date":158,"type":140},"2027-09",{"name":5,"class":6},1]