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Completed

NCT Number: NCT02846467

Information Improvement for Surgical Patients Through Portable Video Media

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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Key information

Conditions

Prostatic Hyperplasia Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Department of the University Hospital of Puerto Real

Puerto Real, Cadiz, 11510, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informed consent trough a portable video media

Other

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

Other names: iURO Application (App)

Written Informed Consent

Other

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

Other names: Traditional informed consent, Standard verbal communication

Primary outcomes

  1. Comprehension of informed consent

    Time frame: Prior to surgery

Secondary outcomes

  1. Comprehension of informed consent

    Time frame: 15 days after surgery

Sponsors and collaborators

Lead sponsor

Hospital Universitario Puerto Real

Other

Collaborators

  • University of Cadiz

Registry information

Official study title

Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 27, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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