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

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 Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other: Patient decision aid

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Recruiting
    • Shuang Ho Hospital
    • Contact: Cheng Jung Wu; Phone Number: 886933971628; Email: b101090126@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Patient decision aid; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision conflicts	Mean score of decisional conflict scale by SURE test using a five-item scale with 5 questions: 1 = agree strongly, 2 = agree, 3 = neutral, 4 = disagree, 5 = disagree strongly.	On the day 1 of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision regret	Mean score of a decision regret scale by DRS test using a five-item scale with 6 questions: 1 = agree strongly, 2 = agree, 3 = neutral, 4 = disagree, 5 = disagree strongly. Two questions are reverse-worded and should be scored in reverse.	A month after surgical intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Rhinitis Symptom Severity	Mean score of a patient-rated visual analogue scale assessing overall rhinitis symptom severity before surgery and after surgery. The response anchors are presented as scores on a line: abscent symptoms = 0, mild symptoms= 1-3, moderate symptoms= 4-6, severe symptoms= 7-10. Functional-impairment descriptors are provided to help calibration.	On the day 1 of admission and A month after surgical intervention
Symptom Impact Frequency on Daily Life	Mean score of a single-item frequency measure capturing how often nasal symptoms impact daily life, recorded as duration: longer than 4 weeks or shorter than 4 weeks. Number of days per week affected is also asked.	On the day 1 of admission and a month after surgical intervention
Nasal Obstruction Symptom Evaluation	Mean score of a five-item patient-reported outcome assessing the impact of nasal obstruction on quality of life over the past month with 5 qeustions. Each item is rated on a 0-4 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, and 4 = unbearable symptoms. Symptoms included: nasal blockage, nasal congestion or swelling, trouble breathing through the nose, trouble sleeping or poor sleep, and inadequate nasal airflow during exercise or activity.	On the day 1 of admission and a month after surgical intervention
24-hour Reflective Total Nasal Symptom Score	Mean score of a four-item composite reflecting nasal symptom severity over the past 24 hours with 4 questions, rated per symptom on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. Symptoms included: nasal congestion, rhinorrhea or postnasal drip, nasal or throat itch or chronic cough, and sneezing.	On the day 1 of admission and a month after surgical intervention
Cough Evaluation Test	Mean score of a five-item cough severity questionnaire with 5 questions, rating cough burden on a 0-4 scale with anchors 0 = none, 1 = rare, 2 = some, 3 = often, 4 = severe. Symptoms included: daytime cough, sleep disturbance due to cough, severe coughing, impact on work, study, and daily activities, and anxiety caused by cough.	On the day 1 of admission and a month after surgical intervention
24-hour Reflective Total Ocular Symptom Score	Mean score of a four-item composite reflecting ocular allergy symptom severity over the past 24 hours with 3 questions, rating per symptom on a 0-3 scale with anchors 0 = no problem, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. Symptoms included: itchy eyes, tearing, and red, swollen or stinging eyes.	On the day 1 of admission and a month after surgical intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: shared decision making; rhinitis; patient decision aid; hypertrophic rhinitis; Carbon dioxide laser turbinoplasty; Submucosal resection of the inferior turbinate; Microdebrider-assisted inferior turbinoplasty; Radiofrequency thermal ablation of the inferior turbinate; Potassium Titanyl Phosphate laser turbinoplasty; chronic hypertrophic rhinitis
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: Shuang Ho Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No