Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient decision aid.
- Who it may be relevant to
- Registry conditions: Allergic Rhinitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid: A Randomized Control Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Decision conflicts [Time frame: On the day 1 of admission]
Secondary outcome measures (1)
- Decision regret [Time frame: A month after surgical intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- Shuang Ho Hospital — New Taipei City
Identifiers
NCT: NCT07435714 · Shuang Ho Hospital