Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Comprehension of informed consent
研究概览
简要总结
The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).
详细描述
The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations.
The standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation.
Technology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations.
To evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany).
The patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are going to receive transurethral resection of bladder or prostate
- •Patients, women and men, older than 18 years without any mental disability
排除标准
- •Patients who refuse to participate in the study
- •Patients who have inability to communicate in spanish.
- •Several visual problems that limit the ability to read written material
结局指标
主要结局
Comprehension of informed consent
时间窗: Prior to surgery
次要结局
- Comprehension of informed consent(15 days after surgery)
研究者
Sebastian Armijos
PhD Urologist
Hospital Universitario Puerto Real
