Information Improvement for Surgical Patients Through Portable Video Media

Hospital Universitario Puerto Real

Status: Completed

Conditions: Bladder Cancer; Prostatic Hyperplasia

Treatments: Other: Written informed consent; Other: Informed consent trough a portable video media

Study type: Interventional

Funder types: Other

Identifiers

NCT02846467

HospitalUPR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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193 participants in 2 patient groups

Portable video media

Experimental group

Description:

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

Treatment:

Other: Informed consent trough a portable video media

Traditional IC

Active Comparator group

Description:

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

Treatment:

Other: Written informed consent