[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053368":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":44,"collaborators":47,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Queen's University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing ERCP",null,"Adult (\\>18 years old) patients undergoing ERCP will be enrolled prospectively. All procedures will be performed according to standard clinical practice (No study intervention). Clinical, procedural, and patient-reported outcome data will be collected for analysis.",[13],"Other: Not applicable- observational study",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Not applicable- observational study","Not applicable - observational study",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Dain R Kim, MSc, MD","CONTACT","4035850249","dain.kim@queensu.ca",[26],{"facility":27,"status":10,"city":28,"state":29,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Kingston Health Sciences Centre","Kingston","Ontario","Canada","CA",{"type":33,"coordinates":34},"Point",[35,36],-76.48098,44.22976,{"lat":36,"lon":35},[39],{"name":40,"role":22,"phone":41,"phoneExt":42,"email":43},"Mandip Rai","6135443400","2292","Mandip.Rai@kingstonhsc.ca",{"type":45,"investigatorFullName":40,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Principal Investigator",[48],{"name":5,"class":6},"100053368","effect-of-patient-anxiety-level-prior-to-undergoing-ercp-and-procedure-tolerability-and-outcomes-100053368",false,"NCT07699731","Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.","The Effect of Pre-procedural Anxiety Level on Procedure Tolerability and Quality of ERCP in Consciously Sedated Patients","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Undergoing ERCP for any indication with conscious sedation\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability or refusal to provide informed consent\n* Cognitive impairment or language barriers precluding questionnaire completion\n* Emergent ERCP where pre-procedural questionnaire administration is not feasible","ALL","18 Years",{"count":59,"type":60},200,"ESTIMATED","OBSERVATIONAL","Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper GI endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied.\n\nThe goal of this prospective observational study is to understand how anxiety before ERCP affects patient experience and tolerance of the procedure.\n\nThis study includes adults (18 years and older) undergoing ERCP with conscious sedation at Kingston Health Sciences Centre. Researchers will measure pre-procedure anxiety and examine how it relates to patient comfort, cooperation during the procedure, and overall patient-reported experience.\n\nThe main questions are whether higher pre-procedure anxiety is associated with lower procedure tolerability and reduced cooperation during ERCP.\n\nParticipants will:\n\n1. Complete a short anxiety questionnaire before the procedure\n2. Undergo ERCP with standard sedation as planned by their care team\n3. Complete a post-procedure questionnaire about comfort, pain, and other symptoms\n4. Have procedure details and outcomes recorded from medical records\n\nEndoscopists will also complete a short survey to state any concerns prior to procedure as well as evaluate patient's cooperation during the procedure.\n\nPatient-reported experience will be compared with physician assessments of cooperation during the procedure.\n\nFindings may help recognize patients at higher risk of distress during ERCP and guide strategies to improve comfort, sedation planning, and overall procedure quality to lead to the best outcomes.",[64,65,66],"Anxiety","Biliary and Pancreatic Diseases","ERCP",[66,68,69,70,71,72,73,74,75],"Endoscopic retrograde cholangiopancreatography","Conscious sedation","Pre-procedural anxiety","Patient experience","STAI-Y","PRO-STEP","Upper endoscopy","Procedural sedation","NOT_YET_RECRUITING","2026-07-09",{"date":79,"type":80},"2026-07-13","ACTUAL",{"date":82,"type":60},"2026-08-01",{"date":84,"type":60},"2027-10-01",{"name":40,"class":6},1]