Information Improvement for Surgical Patients Through Portable Video Media
Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Cadiz
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Puerto Real, Cadiz, Spania, 11510
- Urology Department of the University Hospital of Puerto Real
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Portable video media
Patients who receive informed consent trough portable video media around 10 minutes
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Information provided to patients using the mobile application (iURO app)
Andre navn:
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Aktiv komparator: Traditional IC
Patients who receive traditional IC (written consent) during 10 to 15 minutes
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Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Comprehension of informed consent
Tidsramme: Prior to surgery
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Prior to surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comprehension of informed consent
Tidsramme: 15 days after surgery
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15 days after surgery
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sebastian Armijos Leon, Urologist, Hospital Universitario Puerto Real
- Studieleder: Federico Rodriguez Rubio, Urologist, Univesity of Cadiz
- Studiestol: Jorge Rioja Zuazu, Urologist, Universidad de Zaragoza
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HospitalUPR
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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