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NCT03960723 Clinical Trial

Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Informed Consent Clinical Trial

Official title:
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03960723
Other study ID # IIBSP-CIP-2019-25
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 9, 2019
Est. completion date December 9, 2019

Study information
Verified date September 2023
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess. The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 9, 2019
Est. primary completion date December 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Undergoing surgery and admitted by CSI unit - Provide written informed consent to participate in the study Exclusion Criteria: - Patients who need a legal representative to read, understand and sign the CI

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.

Locations
Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Understanding degree Assessment of the understanding degree of the IC by the patient Before procedure
See also
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