[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659638":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":68,"studyPopulation":57,"armGroups":69,"interventions":82,"overallOfficials":57,"centralContacts":91,"locations":97,"responsibleParty":114,"collaborators":57,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":57,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":57,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":144,"whyStopped":57,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Nigde Omer Halisdemir University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity During First Postoperative Ambulation","Pain intensity during the first postoperative ambulation will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. First ambulation will be performed at the sixth postoperative hour and will include progression from sitting at the bedside to standing and walking. Participants will rate the pain experienced during the first ambulation, with higher scores indicating greater pain intensity.","At the 6th postoperative hour",[14,18,21,25,29,32,36,39,43,46,49,53],{"measure":15,"description":16,"timeFrame":17},"Cumulative Resting Pain Burden (VAS AUC)","Cumulative resting pain burden will be calculated as the area under the curve (AUC) for 0-10 VAS pain scores obtained at rest at the 3rd (pre-intervention), 4th, 6th, 12th, and 24th postoperative hours. AUC will be calculated using the trapezoidal rule, with higher values indicating greater cumulative pain burden.","From the 3rd to the 24th postoperative hour",{"measure":19,"description":20,"timeFrame":17},"Cumulative Movement-Evoked Pain Burden (VAS AUC)","Cumulative movement-evoked pain burden will be calculated as the area under the curve (AUC) for 0-10 VAS pain scores obtained during standardized postoperative movement at the 3rd, 4th, 6th, 12th, and 24th postoperative hours. Movement will consist of standardized in-bed movement at the earlier assessments and mobilization\u002Fambulation at later assessments. AUC will be calculated using the trapezoidal rule, with higher values indicating greater cumulative movement-evoked pain burden.",{"measure":22,"description":23,"timeFrame":24},"Postoperative Pain Intensity at Rest","Pain intensity at rest will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be performed at the 3rd postoperative hour immediately before the study intervention and at the 4th, 6th, 12th, and 24th postoperative hours.","At the 3rd, 4th, 6th, 12th, and 24th postoperative hours",{"measure":26,"description":27,"timeFrame":28},"Postoperative Movement-Evoked Pain Intensity","Movement-evoked pain intensity will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. At the 3rd and 4th postoperative hours, pain will be assessed during standardized in-bed movement. At the 12th and 24th postoperative hours, pain will be assessed during standardized postoperative mobilization.","At the 3rd, 4th, 12th, and 24th postoperative hours",{"measure":30,"description":31,"timeFrame":12},"Number of Steps During First Postoperative Ambulation","Functional performance during first postoperative ambulation will be assessed by recording the total number of steps taken during the first ambulation performed at the 6th postoperative hour.",{"measure":33,"description":34,"timeFrame":35},"Total Rescue Diclofenac Consumption","The cumulative dose of diclofenac administered as first-line rescue analgesia during the first 24 postoperative hours will be recorded in milligrams. Diclofenac 75 mg will be available for clinically significant pain (VAS ≥4) or upon participant request. Higher cumulative doses indicate greater rescue analgesic requirement.","During the first 24 postoperative hours",{"measure":37,"description":38,"timeFrame":35},"Requirement for First-Line Rescue Analgesia","The proportion of participants requiring at least one dose of diclofenac as first-line rescue analgesia during the first 24 postoperative hours will be recorded.",{"measure":40,"description":41,"timeFrame":42},"Time to First Rescue Analgesia","Time from administration of the acupuncture or sham intervention at the 3rd postoperative hour to the first administration of rescue analgesia will be recorded in hours. Participants who do not require rescue analgesia during the observation period will be treated as censored at the end of the 24-hour postoperative follow-up.","From the study intervention at the 3rd postoperative hour through the 24th postoperative hour",{"measure":44,"description":45,"timeFrame":35},"Requirement for Second-Line Opioid Rescue Analgesia","The number and proportion of participants requiring intravenous morphine as second-line rescue analgesia because of inadequate pain control despite first-line rescue analgesia will be recorded.",{"measure":47,"description":48,"timeFrame":35},"Total Rescue Morphine Consumption","The cumulative dose of intravenous morphine administered as second-line rescue analgesia during the first 24 postoperative hours will be recorded in milligrams.",{"measure":50,"description":51,"timeFrame":52},"Acupuncture-Related Adverse Events","Acupuncture- or sham-procedure-related adverse events, including local pain, minor bleeding, hematoma, dizziness, and vasovagal reactions, will be recorded. The number and proportion of participants experiencing at least one intervention-related adverse event will be reported.","From the study intervention through the 24th postoperative hour",{"measure":54,"description":55,"timeFrame":56},"Participant Blinding Assessment","After completion of all 24-hour outcome assessments, participants will be asked which intervention they believe they received: real acupuncture, sham acupuncture, or unsure. Responses will be compared with actual treatment allocation to assess the effectiveness of participant blinding.","At the 24th postoperative hour, after completion of all clinical outcome assessments",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":63,"maskingDescription":64,"whoMasked":65},"DOUBLE","Participants and outcome assessors will be blinded to treatment allocation. Real and sham procedures will be performed using a standardized protocol, with non-penetrating Park sham needles used in the sham group. The practitioner administering the acupuncture or sham procedure cannot be blinded because of the nature of the intervention and will not participate in postoperative pain or functional outcome assessments. Participant blinding will be evaluated after completion of the 24-hour outcome assessments by asking participants whether they believe they received real acupuncture, sham acupuncture, or are unsure. The statistical analysis will be performed using coded treatment groups.",[66,67],"PARTICIPANT","OUTCOMES_ASSESSOR","Acute postoperative pain is common after cesarean delivery and may interfere with early mobilization, maternal recovery, newborn care, and breastfeeding. Acupuncture has been investigated as a non-pharmacological adjunct to postoperative analgesia; however, evidence regarding the effectiveness of specific acupuncture protocols for acute post-cesarean pain remains limited.\n\nThis single-center, parallel-group, sham-controlled randomized clinical trial will investigate the analgesic effectiveness of a single postoperative session of bilateral LI4 (Hegu) and SP6 (Sanyinjiao) acupuncture in women undergoing cesarean delivery under spinal anesthesia. Eligible participants will be randomly allocated in a 1:1 ratio to either real acupuncture or sham acupuncture using non-penetrating Park sham needles. The intervention will be administered at the third postoperative hour.\n\nPostoperative analgesia will be standardized in both groups. Participants will receive paracetamol 1 g intravenously after delivery and umbilical cord clamping, followed by paracetamol 1 g every 8 hours, administered orally once oral intake is tolerated. Diclofenac 75 mg will be available as first-line rescue analgesia for clinically significant pain (VAS ≥4) or upon participant request. If pain remains inadequately controlled despite first-line rescue analgesia, morphine 2 mg intravenously will be available as second-line rescue analgesia. Clinically indicated analgesia will not be withheld or delayed for study purposes. The timing and dose of all rescue analgesics will be recorded.\n\nPain intensity will be assessed using a 0-10 VAS at predefined postoperative time points. Assessments will distinguish pain at rest from movement-evoked pain. At the third postoperative hour, immediately before the study intervention, pain will be assessed at rest and during standardized movement in bed. These assessments will be repeated at the fourth postoperative hour. At the sixth postoperative hour, participants will undergo their first postoperative ambulation. Pain intensity during first ambulation at the sixth postoperative hour will constitute the primary outcome. Pain at rest and during movement will also be evaluated at subsequent postoperative assessments through 24 hours.\n\nFunctional performance during first mobilization will be evaluated by recording the number of steps taken during the first ambulation. Secondary analgesic outcomes will include rescue diclofenac use and total dose, time to first rescue analgesia, and the requirement for and total dose of second-line opioid rescue analgesia. Acupuncture-related adverse events will also be recorded.\n\nAfter completion of the 24-hour clinical outcome assessments, participants will be asked whether they believe they received real acupuncture, sham acupuncture, or are unsure, to assess the effectiveness of participant blinding.",[70,76],{"label":71,"type":72,"description":73,"interventionNames":74},"LI4 + SP6 Acupuncture","EXPERIMENTAL","Participants will receive a single session of bilateral acupuncture at LI4 (Hegu) and SP6 (Sanyinjiao) at the third postoperative hour after cesarean delivery. Sterile acupuncture needles will be inserted at the four acupuncture sites and manually stimulated to elicit de qi. The needles will remain in place for 15 minutes. Participants will receive the standardized postoperative analgesic regimen used in the study, with rescue analgesia available when clinically required.",[75],"Procedure: LI4 + SP6 Acupuncture",{"label":77,"type":78,"description":79,"interventionNames":80},"Sham Acupuncture","SHAM_COMPARATOR","Participants will receive a single sham acupuncture session at the third postoperative hour after cesarean delivery. Non-penetrating Park sham needles will be applied bilaterally at the same LI4 (Hegu) and SP6 (Sanyinjiao) locations used in the real acupuncture group, without skin penetration. The number of application sites, treatment duration (15 minutes), participant positioning, and practitioner interaction will be standardized to match the real acupuncture group. Participants will receive the same standardized postoperative analgesic regimen and rescue analgesia protocol as the acupuncture group.",[81],"Procedure: Park Sham Acupuncture",[83,87],{"type":84,"name":71,"description":85,"armGroupLabels":86,"otherNames":57},"PROCEDURE","A single acupuncture session will be administered at the third postoperative hour after cesarean delivery. Sterile acupuncture needles (0.25 × 25 mm) will be inserted bilaterally at LI4 (Hegu) and SP6 (Sanyinjiao), for a total of four acupuncture sites. Needles will be inserted to an approximate depth of 1.5-2 cm and manually stimulated to elicit de qi. The needles will remain in place for 15 minutes.",[71],{"type":84,"name":88,"description":89,"armGroupLabels":90,"otherNames":57},"Park Sham Acupuncture","A single sham acupuncture session will be administered at the third postoperative hour after cesarean delivery. Non-penetrating Park sham needles will be applied bilaterally at the same LI4 (Hegu) and SP6 (Sanyinjiao) locations used in the real acupuncture group, for a total of four application sites. The sham needles will not penetrate the skin. Treatment duration, participant positioning, and practitioner interaction will be standardized to match the real acupuncture procedure. The sham needles will remain in place for 15 minutes.",[77],[92],{"name":93,"role":94,"phone":95,"phoneExt":57,"email":96},"Pınar Erdoğan, Assoc. Prof.","CONTACT","05233646954","drpinarerdogan@gmail.com",[98],{"facility":99,"status":57,"city":100,"state":101,"zip":102,"country":103,"countryCode":57,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Niğde Ömer Halisdemir University Hospital","Niğde","Niğde Province","51240","Turkey (Türkiye)",{"type":105,"coordinates":106},"Point",[107,108],34.67935,37.96583,{"lat":108,"lon":107},[111],{"name":112,"role":94,"phone":57,"phoneExt":57,"email":113},"Pınar Erdoğan","pinar.erdogan@ohu.edu.tr",{"type":115,"investigatorFullName":112,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Assoc Prof","100659638","li4-and-sp6-acupuncture-for-pain-after-cesarean-delivery-100659638",false,"NCT07869589","LI4 and SP6 Acupuncture for Pain After Cesarean Delivery","Effectiveness of LI4 and SP6 Acupuncture for Acute Postoperative Pain After Cesarean Delivery: A Sham-Controlled Randomized Clinical Trial","Inclusion Criteria:\n\n* Women aged 18-50 years\n* Undergoing elective cesarean delivery under spinal anesthesia\n* Able to understand and use the 0-10 visual analog scale (VAS)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Emergency cesarean delivery\n* Conversion from spinal to general anesthesia or requirement for general anesthesia\n* Known allergy or contraindication to medications included in the standardized postoperative analgesic protocol\n* Presence of infection, skin lesion, or other condition preventing acupuncture or sham application at the LI4 or SP6 sites\n* Known bleeding disorder or clinically significant coagulation abnormality\n* Neurological, musculoskeletal, or other medical condition that would prevent or substantially limit postoperative mobilization\n* Chronic pain requiring regular analgesic medication\n* Regular opioid use before surgery\n* Inability to reliably assess or report pain intensity\n* Any postoperative clinical condition requiring deviation from the planned analgesic or mobilization protocol","FEMALE","18 Years","50 Years",{"count":128,"type":129},140,"ESTIMATED","INTERVENTIONAL",[132],"NA","This randomized, sham-controlled clinical trial will evaluate the effectiveness of acupuncture at bilateral LI4 and SP6 as an adjunct to standard postoperative analgesia for acute pain after cesarean delivery. Women undergoing cesarean delivery under spinal anesthesia will be randomly assigned to receive either real acupuncture at bilateral LI4 and SP6 or sham acupuncture using non-penetrating Park sham needles.\n\nThe acupuncture or sham intervention will be administered at the third postoperative hour. All participants will receive a standardized postoperative analgesic regimen, with additional rescue analgesia available when clinically required.\n\nThe primary outcome will be pain intensity during first postoperative ambulation at the sixth postoperative hour, measured using a 0-10 visual analog scale (VAS). Secondary outcomes will include pain at rest and during movement at predefined postoperative time points, functional performance during first mobilization, rescue analgesic requirements, and acupuncture-related adverse events. Participant blinding will also be assessed after completion of the 24-hour outcome assessments.",[135],"Acute Postoperative Pain After Cesarean Delivery",[137,138,139,140,141,77,142,143],"Cesarean Delivery","Postoperative Pain","Acupuncture","LI4","SP6","Pain Management","Early Mobilization","NOT_YET_RECRUITING","2026-10-04",{"date":147,"type":148},"2026-10-09","ACTUAL",{"date":150,"type":129},"2026-11-01",{"date":152,"type":129},"2027-07-01",{"name":5,"class":6},1]