Prostatic Hyperplasia, Bladder Cancer
Conditions
Keywords
Informed consent, Patient Education, Mobile applications
Brief summary
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).
Detailed description
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.
Interventions
OTHERInformed consent trough a portable video media
Information provided to patients using the mobile application (iURO app)
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
Sponsors
University of Cadiz
Hospital Universitario Puerto Real
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are going to receive transurethral resection of bladder or prostate * Patients, women and men, older than 18 years without any mental disability
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehension of informed consent | Prior to surgery |
Secondary
| Measure | Time frame |
|---|---|
| Comprehension of informed consent | 15 days after surgery |
Countries
Spain
Outcome results
None listed