[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645724":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Sanliurfa Education and Research Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-assisted written patient information","EXPERIMENTAL","Participants receive standardized medical treatment plus investigator-validated AI-assisted written patient information containing the same medical content as the verbal counseling.",[13],"Behavioral: AI-assisted written patient information",{"label":15,"type":16,"description":17,"interventionNames":18},"Standardized verbal counseling","ACTIVE_COMPARATOR","Participants receive standardized medical treatment plus standardized verbal counseling alone.",[19],"Behavioral: Standardized verbal counseling",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Vedat Kaplan, MD","CONTACT","+905459045165","vedat_kaplan_@hotmail.com",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Vedat Kaplan","Principal Investigator","100645724","ai-assisted-written-information-in-symptomatic-hemorrhoidal-disease-100645724",false,"NCT07701798","AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease","Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Symptomatic Hemorrhoidal Disease: A Prospective Randomized Controlled Trial","HD-AI","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Diagnosis of symptomatic hemorrhoidal disease in the outpatient clinic\n3. Conservative\u002Fmedical treatment planned at first evaluation\n4. Ability to read and understand Turkish\n5. Reachable by telephone\n6. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Planned office procedure or surgery\n2. Emergency conditions such as thrombosed external hemorrhoid, strangulation, or massive bleeding\n3. Concomitant anal fissure, anal fistula, perianal abscess, inflammatory bowel disease, or suspicion of anal\u002Fcolorectal malignancy\n4. History of hemorrhoidal intervention or surgery within the last 3 months\n5. Severe cognitive impairment, severe visual problem, or communication barrier\n6. Pregnancy and postpartum period\n7. Serious systemic conditions that would prevent completion of study follow-up","ALL","18 Years",{"count":50,"type":51},220,"ESTIMATED","INTERVENTIONAL",[54],"NA","This single-center, prospective, parallel-group, 1:1 randomized controlled trial compares standardized verbal counseling with AI-assisted written patient information in adults with symptomatic hemorrhoidal disease receiving initial conservative\u002Fmedical treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include quality-of-life change, Patient Global Impression of Change, time to symptom improvement, change in pain\u002Fdiscomfort scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.",[57,58],"Symptomatic Hemorrhoidal Disease","Hemorrhoids Grade I and II",[60,61,62,63,64,65,66],"Hemorrhoidal disease","Hemorrhoids","Treatment adherence","AI-assisted patient information","HEMO-FISS-QoL","PGI-C","Conservative treatment","NOT_YET_RECRUITING","2026-07-08",{"date":70,"type":71},"2026-07-14","ACTUAL",{"date":73,"type":51},"2026-07-15",{"date":75,"type":51},"2026-12-31",{"name":5,"class":6}]