Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Patient comprehension assessed by Patient comprehension questionnaire
研究概览
简要总结
This is a single-center, randomized, double-blind clinical study to compare patient comprehension and anxiety by comparing a traditional paper consent form to a multimedia consent form for patients undergoing transforaminal epidural steroid injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- 是
入选标准
- •18 years of age or older
- •Patients undergoing lumbar transforaminal block for the first time
- •Patients who are able to understand the contents of the video consent form and written consent form.
排除标准
- •Patients who have difficulty understanding or answering consent forms
- •Patients who have previously experienced a transforaminal steroid injection
研究组 & 干预措施
Multimedia informed consent
Multimedia informed consent with videos to explain transforaminal epidural steroid injection
干预措施: Multimedia informed consent (Procedure)
Standard informed consent
A standard consent form to describe the procedure previously used.
干预措施: Standard informed consent (Procedure)
结局指标
主要结局
Patient comprehension assessed by Patient comprehension questionnaire
时间窗: immediately before the procedure
A questionnaire to assess the understanding of the procedure in patients undergoing transforaminal epidural steroid injections, created by three pain medicine specialists. The test consists of 10 questions, all of which are answered with a yes/no response to provide a score from 0 to 10.
次要结局
- Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form(immediately before the procedure)
- Assess patient satisfaction by Patient satisfaction ratings on a Likert scale(immediately after the procedure)
研究者
Pyung-Bok Lee
Principal Investigator
Seoul National University Hospital