[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07090018":3,"trial-entities:NCT07090018":115,"trial-summary:NCT07090018":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":53,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":92,"locations":95,"central_contacts":104,"overall_officials":105,"references":109,"see_also_links":114},"NCT07090018","80475","Empowered Relief: A One-Time Session to Help Postpartum Women Manage Ongoing Pain After Cesarean Delivery","A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery","ENROLLING_BY_INVITATION","2026-12","2025-07","2025-11-20","2025-09-25","Stanford University","OTHER",false,"The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery.",null,[19,20],"Chronic Pain","Cesarean Section Complications",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},60,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"BEHAVIORAL","Empowered Relief","The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.",[35],"1-Session pain relief skills session (Empowered Relief)",[37],"1-Session Pain Relief Skills Intervention",[39,42,45,49],{"measure":40,"timeFrame":41},"Percentage of participants registering for Empowered Relief session","Baseline (up to 1 week)",{"measure":43,"timeFrame":44},"Percentage of participants attending Empowered Relief session","Treatment (up to 2 weeks)",{"measure":46,"description":47,"timeFrame":48},"Participant Satisfaction Scale Score","Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).","1 - 2 weeks Post treatment",{"measure":50,"description":51,"timeFrame":52},"Participant Treatment Skills Use Scale Score","Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).","4 - 6 weeks Post Treatment",[54,58,61,64,68,71,74],{"measure":55,"description":56,"timeFrame":57},"Change from baseline in PROMIS Pain Interference 8a scale score","Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.\n\n(Score range 8 - 40, higher scores represent a greater degree of pain interference).","Baseline, Week 6",{"measure":59,"description":60,"timeFrame":57},"Change from baseline in PROMIS Pain Intensity 3a scale score","Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days.\n\n(Score range 3 - 15, higher score represents a greater degree of pain intensity)",{"measure":62,"description":63,"timeFrame":57},"Change from baseline in Pain Catastrophizing Scale Score","Participants complete Pain Catastrophizing questionnaire, a 13-item scale assessing an individual's pain experience\n\n(Score range 0 - 52, higher score represents a greater degree of pain catastrophizing)",{"measure":65,"description":66,"timeFrame":67},"Change from baseline in PEG scale score (composite)","Participants complete thrice weekly Pain, Enjoyment, General Activity Scale (PEG) questionnaire, a 3-item scale assessing pain interference and intensity via SMS.\n\n(Score range 0 - 30, higher score represents a greater degree of pain intensity\u002Finterference)","From enrollment to the end of study completion at 6 weeks",{"measure":69,"description":70,"timeFrame":67},"Change from baseline in PEG scale score (pain interference)","Participants complete thrice weekly PEG questionnaire, to assess pain interference via SMS.\n\n(Score range 0 - 20, higher score represents a greater degree of interference)",{"measure":72,"description":73,"timeFrame":67},"Change from baseline in PEG scale score (pain intensity)","Participants complete thrice weekly PEG questionnaire to assess pain intensity, via SMS.\n\n(Score range 0 - 10, higher score represents a greater degree of pain intensity)",{"measure":75,"description":76,"timeFrame":67},"Response rate to individual items of the PEG scale score via SMS","Participant percentage responding to items of the thrice weekly PEG questionnaire, a 3-item scale assessing pain interference and intensity via SMS.\n\n(Score range 0 - 3; higher scores indicate higher response rate)","FEMALE","18 Years",{"inclusion":80,"exclusion":87,"raw_text":91},[81,82,83,84,85,86],"Females 18 years of age or older","Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth","has moderate\u002Fsevere pain, scoring ≥ 4\u002F10 on the numerical\u002Fvisual analog scale that continues at 6 weeks postpartum","English fluency","Ability to adhere to and complete study protocols","Access to smart device for zoom \u002F video meetings",[88,89,90],"\\\u003C18yrs","Chronic pain prior to pregnancy","Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and\u002For full participation in the study.","Inclusion Criteria:\n\n* Females 18 years of age or older\n* Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth\n* has moderate\u002Fsevere pain, scoring ≥ 4\u002F10 on the numerical\u002Fvisual analog scale that continues at 6 weeks postpartum\n* English fluency\n* Ability to adhere to and complete study protocols\n* Access to smart device for zoom \u002F video meetings\n\nExclusion Criteria:\n\n* \\\u003C18yrs\n* Chronic pain prior to pregnancy\n* Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and\u002For full participation in the study.",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":13,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"Palo Alto","California","94304","United States",{"lat":102,"lon":103},37.44188,-122.14302,[],[106],{"name":107,"affiliation":13,"role":108},"Pervez Sultan, MBChB, FRCA, MD(Res)","PRINCIPAL_INVESTIGATOR",[110],{"pmid":111,"type":112,"citation":113},"40279839","BACKGROUND","Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016\u002Fj.jclinane.2025.111832. Epub 2025 Apr 24.",[],{"nct_id":4,"conditions":116,"biomarkers":117},[20,19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]