Information Improvement for Surgical Patients Through Portable Video Media

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Prostatic Hyperplasia Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Portable video media

Patients who receive informed consent trough portable video media around 10 minutes

Group Type EXPERIMENTAL

Informed consent trough a portable video media

Intervention Type OTHER

Information provided to patients using the mobile application (iURO app)

Traditional IC

Patients who receive traditional IC (written consent) during 10 to 15 minutes

Group Type ACTIVE_COMPARATOR

Written informed consent

Intervention Type OTHER

Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.

Interventions

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Informed consent trough a portable video media

Information provided to patients using the mobile application (iURO app)

Intervention Type OTHER

Written informed consent

Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.

Intervention Type OTHER

Other Intervention Names

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iURO Application (App) Traditional informed consent Standard verbal communication

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No