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临床试验/NCT02846467
NCT02846467已完成不适用

Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.

Hospital Universitario Puerto Real2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2013年12月1日最近更新:
适应症

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

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

发起方
Hospital Universitario Puerto Real
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Armijos

PhD Urologist

Hospital Universitario Puerto Real

研究点 (2)

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