[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545439":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":54,"collaborators":58,"id":61,"slug":18,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Connecticut","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IBS-PPSM intervention group","EXPERIMENTAL","After the baseline visit, the IBS-PPSM group will receive 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting. The IBS-PPSM group will be taught to use the abdominal belt\u002Fsmart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.",[13],"Behavioral: IBS-PPSM intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"IBS-control group","NO_INTERVENTION","The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt\u002Fsmart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","IBS-PPSM intervention","IBS-PPSM intervention includes 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Hugo F Posada-Quintero","CONTACT","8604861556","hugo.posada-quintero@uconn.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Vernon Cottage, Depot Campus","RECRUITING","Storrs","Connecticut","06269","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-72.24952,41.80843,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Maria Groza","573-529-9499","maria.groza@uconn.edu",{"name":52,"role":28,"phone":18,"phoneExt":18,"email":53},"Stephen Kenton","kenton@easternct.edu",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Hugo Posada-Quintero","Assistant Professor",[59],{"name":60,"class":6},"Yale University","100545439",false,"NCT06381921","Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain","OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain","OIME","Inclusion Criteria:\n\n* Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain.\n* Men and women 18-50 years old\n* Able to read and speak English\n* Daily access to a computer with internet access.\n\nExclusion Criteria:\n\n* Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.\n* Celiac disease or inflammatory bowel disease\n* Diabetes mellitus; d) Serious mental health conditions\n* Women during pregnancy or within 3 months post-partum period\n* Self- reported Regular use of opioids or other illicit substances.\n* Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.",true,"ALL","18 Years","50 Years",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"NA","The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.",[80],"Abdominal Pain",[82,83,84,85,86],"visceral pain","irritable bowel syndrome","autonomic and muscular activities","biosignals","personalized pain self-management","2025-09-08",{"date":89,"type":90},"2025-09-15","ACTUAL",{"date":87,"type":90},{"date":93,"type":74},"2029-02-28",{"name":5,"class":6},1]