[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654489":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":58,"interventions":65,"overallOfficials":51,"centralContacts":51,"locations":70,"responsibleParty":88,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":51,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":51,"enrollmentInfo":106,"targetDuration":51,"studyType":109,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":124,"whyStopped":51,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of enrolled patients that complete the Empowered Relief session","The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.","Within 2 weeks of enrollment",[14,18,22,26,30,34,37,41,45,48],{"measure":15,"description":16,"timeFrame":17},"Proportion of screened patients who are eligible for the study","The proportion of screened patients that meet the study eligibility criteria.","During screening, at approximately 6 weeks postpartum",{"measure":19,"description":20,"timeFrame":21},"Proportion of eligible patients that consent to study from those approached","The proportion of eligible patients who provide informed consent and enroll in the study.","During screening and enrollment, at approximately 6 weeks postpartum",{"measure":23,"description":24,"timeFrame":25},"Proportion of recruited patients who register for the Empowered Relief session","The proportion of recruited patients who register for the Empowered Relief session.","Within 1 week of enrollment",{"measure":27,"description":28,"timeFrame":29},"Proportion of recruited patients who attend the Empowered Relief session","The proportion of recruited patients who attend an Empowered Relief session.","Within 2 weeks of baseline",{"measure":31,"description":32,"timeFrame":33},"Treatment Appraisal score","Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention","Immediately after the Empowered Relief session, up to 2 weeks post-treatment",{"measure":35,"description":36,"timeFrame":33},"Qualitative feedback regarding the Empowered Relief intervention","Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire.",{"measure":38,"description":39,"timeFrame":40},"Participant Treatment Skills Use Scale score","Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills.","Weekly from completion of the Empowered Relief session through 12 weeks postpartum",{"measure":42,"description":43,"timeFrame":44},"Adherence to Study Procedures: completion rate of scheduled surveys","The percentage of scheduled study surveys completed by enrolled participants.","From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum",{"measure":46,"description":47,"timeFrame":44},"Adherence to study procedures: completion rate of scheduled PEG assessments","The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.",{"measure":49,"description":50,"timeFrame":44},"Adherence to study procedures: proportion of participants retained through end-of-study follow-up","The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment.",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"NA","SINGLE_GROUP","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE",[59],{"label":60,"type":61,"description":62,"interventionNames":63},"Empowered Relief","EXPERIMENTAL","Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded).",[64],"Behavioral: Empowered Relief",[66],{"type":67,"name":60,"description":68,"armGroupLabels":69,"otherNames":51},"BEHAVIORAL","A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded).",[60],[71],{"facility":72,"status":51,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Stanford Medicine Children's Health - Specialty Services, Welch Road","Palo Alto","California","94304","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-122.14302,37.44188,{"lat":82,"lon":81},[85],{"name":86,"role":87,"phone":51,"phoneExt":51,"email":51},"Pervez Sultan, MD","PRINCIPAL_INVESTIGATOR",{"type":87,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Pervez Sultan","Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)",[92,95],{"name":93,"class":94},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":96,"class":94},"National Institute on Drug Abuse (NIDA)","100654489","reducing-chronic-pain-following-cesarean-delivery-100654489",false,"NCT07799883","Reducing Chronic Pain Following Cesarean Delivery","A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery","Inclusion Criteria:\n\n1. Complete informed consent.\n2. Age 18 years or above.\n3. Postpartum woman who delivered by cesarean within the Stanford Healthcare system.\n4. Viable birth (singleton or multiple gestation).\n5. All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay).\n6. All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)\n7. Attend the 6-week postpartum clinic visit.\n8. Any pain intensity (numeric rating scale \\[NRS\\] \\>0\u002F10) and\u002For pain interference (PROMIS pain interference 8a score \\>8) at 6 weeks postpartum.\n9. English fluency, with ability to read and write.\n10. Ability to adhere to and complete study procedures.\n11. Access to a smart device if attending ER session via Zoom.\n\nExclusion Criteria:\n\n1. Age under 18 years.\n2. Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.\n3. Unable or unwilling to provide informed consent.\n4. Chronic pain prior to pregnancy.","FEMALE","18 Years",{"count":107,"type":108},30,"ESTIMATED","INTERVENTIONAL",[53],"This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and\u002For pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.",[113,114,115],"Chronic Pain","Cesarean Section Complications","Postpartum",[60,117,118,119,120,121,122,113,123,115],"Postpartum Pain","Cesarean Section","Caesarean Section","Cesarean Delivery","Pain Interference","Pain Management","Chronic Postsurgical Pain","NOT_YET_RECRUITING","2026-09-23",{"date":127,"type":128},"2026-09-28","ACTUAL",{"date":130,"type":108},"2026-10-05",{"date":132,"type":108},"2027-03-14",{"name":5,"class":6},1]