An interventional study of Patient decision aid in Allergic Rhinitis, sponsored by Taipei Medical University Shuang Ho Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Health services research
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 158 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 102 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Usual counseling in the clinical encounter, when patients choose among five surgical interventions for hypertrophic rhinitis.
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.
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.
Time frame: On the day 1 of admission
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.
Time frame: A month after surgical intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On the day 1 of admission and a month after surgical intervention
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Taipei Medical University Shuang Ho Hospital →