NCT07435714 Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
| NCT ID | NCT07435714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University Shuang Ho Hospital |
| Condition | Allergic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 158 participants in total. It began in 2026-03-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07435714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Allergic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07435714 currently recruiting?
Yes, NCT07435714 is actively recruiting participants. Visit ClinicalTrials.gov or contact Taipei Medical University Shuang Ho Hospital to inquire about joining.
Where is the NCT07435714 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT07435714 clinical trial?
NCT07435714 is sponsored by Taipei Medical University Shuang Ho Hospital. The trial plans to enroll 158 participants.