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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with chronic hypertrophic rhinitis.

• Outpatients or inpatients scheduled to undergo surgical intervention.

• Aged 18 years or older and able to communicate in Chinese.

Locations
Other Locations
Taiwan
Shuang Ho Hospital
RECRUITING
New Taipei City
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 158
Treatments
No_intervention: Control
Usual counseling in the clinical encounter, when patients choose among five surgical interventions for hypertrophic rhinitis.
Experimental: Patient decision aid
A Patient Decision Aid is used in this arm in the clinical encounter. A tool designed to facilitate shared decision making when patients choose among five surgical interventions for hypertrophic rhinitis.
Related Therapeutic Areas
Sponsors
Leads: Taipei Medical University Shuang Ho Hospital

This content was sourced from clinicaltrials.gov