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| Name | Class |
|---|---|
| University of Cadiz | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable video media | Experimental | Patients who receive informed consent trough portable video media around 10 minutes |
|
| Traditional IC | Active Comparator | Patients who receive traditional IC (written consent) during 10 to 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informed consent trough a portable video media | Other | Information provided to patients using the mobile application (iURO app) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehension of informed consent | Prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehension of informed consent | 15 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Armijos Leon, Urologist | Hospital Universitario Puerto Real | Principal Investigator |
| Federico Rodriguez Rubio, Urologist | Univesity of Cadiz | Study Director |
| Jorge Rioja Zuazu, Urologist | Universidad de Zaragoza | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Department of the University Hospital of Puerto Real | Puerto Real | Cadiz | 11510 | Spain |
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| Label | URL |
|---|---|
| Abstract entitled: "MHealth (Mobile Health):The use of portable video media versus standard verbal communication in the informed consent", presented at 5th Meeting of Uro-Technology (ESUT) held in Athens, Greece | View source |
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The database with the demographic and results of the participant is going to be available during the next six months. The information will be send with an email request.
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Written informed consent | Other | Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate. |
|
|
| D052801 |
| Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |