Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07435714

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Decision conflicts

    Time frame: On the day 1 of admission

    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.

Secondary outcomes

  1. Decision regret

    Time frame: A month after surgical intervention

    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.

Other outcomes

  1. Visual Analogue Scale for Rhinitis Symptom Severity

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

    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.

  2. Symptom Impact Frequency on Daily Life

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

    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.

  3. Nasal Obstruction Symptom Evaluation

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

    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.

  4. 24-hour Reflective Total Nasal Symptom Score

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

    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.

  5. Cough Evaluation Test

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

    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.

  6. 24-hour Reflective Total Ocular Symptom Score

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

    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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.