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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Start date changed from estimate of Feb 1, 2026 to Mar 1, 2026
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07435714
Lead Sponsor Taipei Medical University Shuang Ho Hospital
Conditions
(from sponsor)
Allergic Rhinitis
Related terms Rhinitis, Rhinitis, Allergic
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov