跳至主要内容
临床试验/NCT07435714
NCT07435714招募中不适用

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

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
158
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验