Health TrialsbyHealthPanel

AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

ConditionsSymptomatic Hemorrhoidal DiseaseHemorrhoids Grade I and II
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanliurfa Education and Research Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Planned office procedure or surgery

Emergency conditions such as thrombosed external hemorrhoid, strangulation, or massive bleeding

Concomitant anal fissure, anal fistula, perianal abscess, inflammatory bowel disease, or suspicion of anal/colorectal malignancy

History of hemorrhoidal intervention or surgery within the last 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted written patient information

    Behavioral

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

  • Standardized verbal counseling

    Behavioral

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: AI-assisted written patient informationExperimental treatment 1 intervention
Group B: Standardized verbal counselingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Patient Global Impression of Change at Day 28

Patient Global Impression of Change assessed at Day 28.

Time frame
Day 28
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanliurfa Education and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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