Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07435714

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
158 (estimated)
Sponsor
Taipei Medical University Shuang Ho Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPatient decision aidThe Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with hypertrophic rhinitis. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of five surgical interventions, knowledge of treatment outcomes, and by clarifying personal values.

Timeline

Start date
2026-02-01
Primary completion
2027-04-30
Completion
2027-07-31
First posted
2026-02-27
Last updated
2026-02-27

Source: ClinicalTrials.gov record NCT07435714. Inclusion in this directory is not an endorsement.