Information Improvement for Surgical Patients Through Portable Video Media
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|ClinicalTrials.gov Identifier: NCT02846467|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia Bladder Cancer||Other: Informed consent trough a portable video media Other: Written informed consent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||April 2016|
Experimental: Portable video media
Patients who receive informed consent trough portable video media around 10 minutes
Other: Informed consent trough a portable video media
Information provided to patients using the mobile application (iURO app)
Other Name: iURO Application (App)
Active Comparator: Traditional IC
Patients who receive traditional IC (written consent) during 10 to 15 minutes
Other: Written informed consent
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
- Comprehension of informed consent [ Time Frame: Prior to surgery ]
- Comprehension of informed consent [ Time Frame: 15 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846467
|Urology Department of the University Hospital of Puerto Real|
|Puerto Real, Cadiz, Spain, 11510|
|Principal Investigator:||Sebastian Armijos Leon, Urologist||Hospital Universitario Puerto Real|
|Study Director:||Federico Rodriguez Rubio, Urologist||Univesity of Cadiz|
|Study Chair:||Jorge Rioja Zuazu, Urologist||Universidad de Zaragoza|