An interventional study of Informed consent trough a portable video media and Written informed consent in Prostatic Hyperplasia and Bladder Cancer, sponsored by Hospital Universitario Puerto Real. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-10.
Sponsored by Hospital Universitario Puerto Real · Not applicable, Interventional, and Supportive care
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 193 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with Hospital Universitario Puerto Real as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who receive informed consent trough portable video media around 10 minutes
Other: Informed consent trough a portable video media
Patients who receive traditional IC (written consent) during 10 to 15 minutes
Other: Written informed consent
Information provided to patients using the mobile application (iURO app)
Also known as: iURO Application (App)
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
Also known as: Traditional informed consent, Standard verbal communication
Comprehension of informed consent
Time frame: Prior to surgery
Comprehension of informed consent
Time frame: 15 days after surgery
Plan to share: Yes — The database with the demographic and results of the participant is going to be available during the next six months. The information will be send with an email request.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.