Clinical Trial

Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid

Recruiting
View on ClinicalTrials.gov →
Summary
This study is a prospective randomized controlled trial that aims to enroll 158 patients diagnosed with chronic hypertrophic rhinitis who are candidates for inferior turbinate surgery. Participants will be randomly assigned to either the "standard group" or the "PDA group." The standard group will receive conventional shared decision-making (SDM) explanations using verbal and visual aids, while the PDA group will additionally receive a printed patient decision aid (PDA) to assist in evaluating the pros and cons of each surgical option. The study will assess patients' decision certainty and decision regret using the SURE scale and the Decision Regret Scale (DRS), respectively, administered before surgery and one month postoperatively. Surgical satisfaction and outcomes will also be evaluated using pre- and postoperative symptom questionnaires. All data will be collected and analyzed by blinded outcome assessors to ensure objectivity. This study involves no invasive procedures and is classified as a low-risk behavioral study. The primary aim is to optimize clinical decision-making processes for patients with chronic hypertrophic rhinitis considering surgical intervention in the otolaryngology setting.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-15
Trial Details
NCT Number NCT07435714
Lead Sponsor Taipei Medical University Shuang Ho Hospital
Conditions Allergic Rhinitis
Enrollment 158 participants
Start Date 2026-03-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-14