An interventional study of AI-assisted written patient information and Standardized verbal counseling in Symptomatic Hemorrhoidal Disease and Hemorrhoids Grade I and II, sponsored by Sanliurfa Education and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Sanliurfa Education and Research Hospital · Not applicable, Interventional, and Health services research
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.
This is a single-center, prospective, parallel-group, 1:1 randomized controlled trial in adults with symptomatic hemorrhoidal disease for whom conservative/medical treatment is planned at the initial evaluation. After baseline assessment, participants will be randomized by sealed-envelope or computer-based block randomization into two groups. The control group will receive standardized verbal counseling. The intervention group will receive investigator-validated AI-assisted written patient information containing the same medical content. Standard medical treatment will be identical in both groups, and the only difference will be the method of information delivery. Participants will be assessed at baseline, day 7, day 14, and day 28. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include change in HEMO-FISS-QoL, PGI-C response, time to symptom improvement, change in pain/discomfort visual analog scale scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 220 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Sanliurfa Education and Research Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standardized medical treatment plus investigator-validated AI-assisted written patient information containing the same medical content as the verbal counseling.
Behavioral: AI-assisted written patient information
Participants receive standardized medical treatment plus standardized verbal counseling alone.
Behavioral: Standardized verbal counseling
Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
Complete treatment adherence at Day 14
Complete treatment adherence at Day 14, defined as full adherence to the prescribed medical treatment and lifestyle recommendations according to the study follow-up form.
Time frame: Day 14
Change in HEMO-FISS-QoL total score from baseline to Day 28
Change in health-related quality of life measured by the HEMO-FISS-QoL total score from baseline to Day 28.
Time frame: Baseline and Day 28
Patient Global Impression of Change at Day 28
Patient Global Impression of Change assessed at Day 28.
Time frame: Day 28
Time to symptom improvement
Time from baseline to the first patient-reported improvement in hemorrhoidal symptoms, measured in days.
Time frame: Up to Day 28
Change in pain/discomfort score from baseline to Day 28
Change in pain or discomfort assessed using a Visual Analog Scale from baseline to Day 28.
Time frame: Baseline and Day 28
Change in bleeding symptom severity from baseline to Day 28
Change in patient-reported bleeding symptoms from baseline to Day 28.
Time frame: Baseline and Day 28
Change in swelling symptom severity from baseline to Day 28
Change in patient-reported swelling symptoms from baseline to Day 28.
Time frame: Baseline and Day 28
Change in itching symptom severity from baseline to Day 28
Change in patient-reported itching symptoms from baseline to Day 28.
Time frame: Baseline and Day 28
Change in soiling symptom severity from baseline to Day 28
Change in patient-reported soiling symptoms from baseline to Day 28.
Time frame: Baseline and Day 28
Plan to share: No — Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
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Sanliurfa Education and Research Hospital