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Clinical Trials/NCT07435714
NCT07435714RecruitingNot Applicable

Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid: A Randomized Control Trial

Taipei Medical University Shuang Ho Hospital1 site in 1 country158 target enrollmentStarted: March 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
158
Locations
1

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with chronic hypertrophic rhinitis.
  • Outpatients or inpatients scheduled to undergo surgical intervention.
  • Aged 18 years or older and able to communicate in Chinese.

Exclusion Criteria

  • Presence of other structural nasal pathologies (e.g., nasal polyps, tumors).
  • Patients undergoing emergency surgery.
  • Individuals unable to live independently or fully comprehend the questionnaire content.
  • Individuals unable to complete the questionnaires.

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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