Bladder Cancer Clinical Trial
Official title:
Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
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).
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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