Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standardized verbal counseling | Active Comparator | Participants receive standardized medical treatment plus standardized verbal counseling alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted written patient information | Behavioral | Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 28 |
| Patient Global Impression of Change at Day 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vedat Kaplan, MD | Contact | +905459045165 | vedat_kaplan_@hotmail.com |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.
Not provided
Not provided
Not provided
Not provided
| Standardized verbal counseling | Behavioral | Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment. |
|
Patient Global Impression of Change assessed at Day 28.
| Day 28 |
| Time to symptom improvement | Time from baseline to the first patient-reported improvement in hemorrhoidal symptoms, measured in days. | 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. | 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. | 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. | 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. | 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. | Baseline and Day 28 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |