[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608649":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":12,"centralContacts":74,"locations":85,"responsibleParty":104,"collaborators":12,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":12,"enrollmentInfo":117,"targetDuration":12,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":137,"whyStopped":12,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8,13,19,24,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"No Intervention","NO_INTERVENTION","Usual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Optimized Anesthetic Gel Timing","EXPERIMENTAL","2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.",[18],"Other: Optimized Timing of Intravesical Lidocaine Gel",{"label":20,"type":15,"description":21,"interventionNames":22},"Calming Music","Patients listen to a standardized calming playlist via headphones during the procedure.",[23],"Behavioral: Calming Music During Procedure",{"label":25,"type":15,"description":26,"interventionNames":27},"Visual Distraction","Patients view standardized visual content on a tablet\u002Fmonitor positioned for comfort-focused distraction.",[28],"Behavioral: Visual Distraction with Screen Content",{"label":30,"type":15,"description":31,"interventionNames":32},"Ambient Lighting","Procedure performed under standardized calming ambient lighting (blue-hue) per protocol.",[33],"Other: Calming Ambient Lighting",{"label":35,"type":15,"description":36,"interventionNames":37},"Peak-End Modification","At the end of the procedure the flexible cystoscope is deliberately left in the bladder for 2 minutes, without manipulation, to reduce intensity\u002Fdiscomfort, based on the psychological principle of the \"peak-end rule,\" aiming to improve overall remembered experience of the procedure.",[38],"Behavioral: Peak-End Modification of Procedure",[40,47,55,62,68],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Optimized Timing of Intravesical Lidocaine Gel","Procedural modification of intravesical anesthetic gel administration. Lidocaine gel is instilled before and after flexible cystoscopy or bladder instillation to optimize mucosal anesthesia. This differs from standard practice where timing is not standardized - usually just before flexible cystoscopy.",[14],[45,46],"Anesthetic Gel Timing Modification","Lidocaine Gel Administration Interval",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"BEHAVIORAL","Calming Music During Procedure","Participants listen to a standardized playlist of calming instrumental music delivered through headphones during the procedure. Intervention is intended to reduce procedural anxiety and discomfort.",[20],[53,54],"Relaxing Music","Music Therapy",{"type":48,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Visual Distraction with Screen Content","Participants watch standardized visual content (e.g., relaxing video) on a screen or tablet during cystoscopy or bladder instillation. Designed to distract attention and enhance comfort.",[25],[60,61],"Video Distraction","Screen Viewing",{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Calming Ambient Lighting","Flexible cystoscopy or intravesical instillation performed under standardized calming ambient lighting (blue-hue) instead of standard clinical lighting. Intervention aims to promote relaxation and reduce anxiety.",[30],[67],"Lighting Modification",{"type":48,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Peak-End Modification of Procedure","Modification of the procedural ending based on the psychological \"peak-end rule.\" The end of the cystoscopy or instillation is deliberately altered to reduce final discomfort, aiming to improve overall remembered patient experience.",[35],[73],"Peak-End Rule Adjustment",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":12,"email":79},"Nicholas E Power, MD","CONTACT","519-667-6787","nicholas.power@lhsc.on.ca",{"name":81,"role":77,"phone":82,"phoneExt":83,"email":84},"Kaydee Connors","519-685-8500","56366","kaydee.connors@lhsc.on.ca",[86],{"facility":87,"status":12,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Victoria Hospital - London Health Sciences Center","London","Ontario","N6A 5W9","Canada","CA",{"type":94,"coordinates":95},"Point",[96,97],-81.23304,42.98339,{"lat":97,"lon":96},[100,101],{"name":81,"role":77,"phone":82,"phoneExt":83,"email":84},{"name":102,"role":103,"phone":12,"phoneExt":12,"email":12},"Lorraine Scanlon, MD","SUB_INVESTIGATOR",{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Nicholas Power","Principle Investigator","100608649","enhancing-patient-comfort-and-reducing-anxiety-during-flexible-cystoscopy-and-bladder-instillation-in-bladder-cancer-patients-a-randomized-controlled-trial-and-observational-study-100608649",false,"NCT07204301","Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study","Flexi-comfort","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of bladder cancer undergoing diagnostic\u002Fsurveillance flexible cystoscopy or intravesical bladder instillation in the outpatient urology clinic\n* Able to provide informed consent\n\nExclusion Criteria:\n\nIndividuals \\\u003C18 years of age.\n\n* Individuals unable to provide informed consent (e.g., diminished or fluctuating capacity).\n* Individuals unable to communicate verbally with study staff (e.g., severe speech\u002Fhearing impairment without assistive support available).\n* Individuals with severe cognitive impairment or acute distress at the time of approach that prevents informed consent.\n* Individuals with known hypersensitivity or allergy to lidocaine, topical anesthetic gel, or any components used in the procedure.\n* Individuals for whom, in the opinion of the treating urologist, participation would pose undue clinical risk or interfere with urgent clinical care.","ALL","18 Years",{"count":118,"type":119},378,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this clinical trial is to learn if certain comfort-enhancing interventions can reduce pain and anxiety during flexible cystoscopy and bladder instillation in patients with bladder cancer. The main questions it aims to answer are:\n\n* Do these interventions reduce patient-reported anxiety during the procedure?\n* Do these interventions reduce patient-reported pain or discomfort during the procedure?\n\nResearchers will compare patients receiving comfort interventions (such as timing of anesthetic gel, calming music, or visual distraction) to those receiving standard care to see if these changes improve patient experience.\n\nParticipants will:\n\n* Undergo a flexible cystoscopy or bladder instillation as part of their usual care\n* Be randomly assigned to receive one or more comfort interventions, or standard care\n* Complete short questionnaires about their pain, comfort, and anxiety",[125],"Bladder Cancer",[127,128,129,130,131,132,133,134,135,136],"flexible cystoscopy","bladder instillation","Patient comfort","Anxiety reduction","Pain management","Urologic oncology","Bladder cancer surveillance","Patient-reported outcomes","Procedural anxiety","Minimally invasive urology","NOT_YET_RECRUITING","2025-09-24",{"date":140,"type":141},"2025-10-02","ACTUAL",{"date":143,"type":119},"2025-11-01",{"date":145,"type":119},"2026-07-01",{"name":5,"class":6},1]