Information Improvement for Surgical Patients Through Portable Video Media

Not Applicable

Completed

• Conditions: Bladder Cancer; Prostatic Hyperplasia
• Interventions: Other: Informed consent trough a portable video media; Other: Written informed consent

• Registration Number: NCT02846467
• Lead Sponsor: Hospital Universitario Puerto Real

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Portable video media	Informed consent trough a portable video media	Patients who receive informed consent trough portable video media around 10 minutes
Traditional IC	Written informed consent	Patients who receive traditional IC (written consent) during 10 to 15 minutes

Primary Outcome Measures

Name	Time	Method
Comprehension of informed consent	Prior to surgery

Secondary Outcome Measures

Name	Time	Method
Comprehension of informed consent	15 days after surgery

Trial Locations

Locations (1)

Urology Department of the University Hospital of Puerto Real; 🇪🇸 Puerto Real, Cadiz, Spain