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AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

NCT07701798 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Symptomatic Hemorrhoidal Disease
  • Hemorrhoids Grade I and II

Interventions

BEHAVIORAL

AI-assisted written patient information

Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.

BEHAVIORAL

Standardized verbal counseling

Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Sponsors & Collaborators

  • Sanliurfa Education and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701798 on ClinicalTrials.gov