Hemorrhoids Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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/medical 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/discomfort scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Diagnosis of symptomatic hemorrhoidal disease in the outpatient clinic

• Conservative/medical treatment planned at first evaluation

• Ability to read and understand Turkish

• Reachable by telephone

• Provision of written informed consent

Locations
Other Locations
Turkey
Sanliurfa Education and Research Hospital
RECRUITING
Sanliurfa
Contact Information
Primary
Vedat Kaplan, MD
vedat_kaplan_@hotmail.com
+905459045165
Time Frame
Start Date: 2026-07-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 220
Treatments
Experimental: AI-assisted written patient information
Participants receive standardized medical treatment plus investigator-validated AI-assisted written patient information containing the same medical content as the verbal counseling.
Active_comparator: Standardized verbal counseling
Participants receive standardized medical treatment plus standardized verbal counseling alone.
Related Therapeutic Areas
Sponsors
Leads: Sanliurfa Education and Research Hospital

This content was sourced from clinicaltrials.gov