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

NCT07435714 | Recruiting

• 1 other identifier: Shuang Ho Hospital
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

hypertrophic rhinitis; shared decision making; patient decision aid; 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; rhinitis; chronic hypertrophic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Decision regret

  A month after surgical intervention

Other Outcomes (6)

• Visual Analogue Scale for Rhinitis Symptom Severity

  On the day 1 of admission and A month after surgical intervention

• Symptom Impact Frequency on Daily Life

  On the day 1 of admission and a month after surgical intervention

• Nasal Obstruction Symptom Evaluation

  On the day 1 of admission and a month after surgical intervention

Study Arms (2)

Control

NO INTERVENTION

Usual counseling in the clinical encounter, when patients choose among five surgical interventions for hypertrophic rhinitis.

Patient decision aid

EXPERIMENTAL

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

Interventions

Patient decision aid OTHER

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.

Patient decision aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient decision aid

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-01

Locations

TW (1)