Allergic RhinitisNCT07435714
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
A study testing Patient decision aid in people with Allergic Rhinitis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Patient decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic hypertrophic rhinitis.
- Outpatients or inpatients scheduled to undergo surgical intervention.
- Aged 18 years or older and able to communicate in Chinese.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital
New Taipei City, 235
Cheng Jung Wu, 886933971628, b101090126@gmail.com
About this study
Official title: 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Patient decision aid
- 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
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day 1 of admission
Secondary outcomes (1)
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.
Measured: A month after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient decision aid
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435714
- Sponsor's protocol ID
- Shuang Ho Hospital
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07435714
- Acronym / sponsor ID
- Shuang Ho Hospital
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patient decision aid
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual counseling in the clinical encounter, when patients choose among five surgical interventions for hypertrophic rhinitis. |
| Patient decision aid | Experimental | Other: Patient decision aidA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with chronic hypertrophic rhinitis.
- Outpatients or inpatients scheduled to undergo surgical intervention.
- Aged 18 years or older and able to communicate in Chinese.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient decision aidThe 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. | Other | Patient decision aid |
Primary outcome
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.
1 secondary outcome
Decision regret
Time frame: A month after surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient decision aid in people with Allergic Rhinitis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflicts (time frame: On the day 1 of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.