Information Improvement for Surgical Patients Through Portable Video Media

Study Overview
=================
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.

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

Conditions
-----------------
Prostatic Hyperplasia, Bladder Cancer

Intervention / Treatment
-----------------
* Other: Informed consent trough a portable video media
* Other: Written informed consent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portable video media<br>Patients who receive informed consent trough portable video media around 10 minutes | Other: Informed consent trough a portable video media<br>* Information provided to patients using the mobile application (iURO app)<br>* Other names: iURO Application (App);|
| Active Comparator: Traditional IC<br>Patients who receive traditional IC (written consent) during 10 to 15 minutes | Other: Written informed consent<br>* Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.<br>* Other names: Standard verbal communication;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of informed consent |  | Prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of informed consent |  | 15 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Informed consent, Patient Education, Mobile applications