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NCT05414435 Clinical Trial

Informed Consent in Endoscopy: Read, Understood or Merely Signed?

Informed Consent Clinical Trial

Official title:
Informed Consent in Endoscopy: Read, Understood or Merely Signed?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05414435
Other study ID # CHTV07/2022.1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date April 30, 2022

Study information
Verified date June 2022
Source Centro Hospitalar Tondela-Viseu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed. The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients able to autonomously give informed consent - Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation. Exclusion Criteria: - Patients refered to urgent endoscopic procedures - Patients refered for endoscopic procedures with deep sedation

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Reading of informed consent form
Patients that adequately read informed consent forms

Locations
Country Name City State
Portugal Centro Hospitalar Tondela Viseu Viseu

Sponsors (1)
Lead Sponsor Collaborator
Centro Hospitalar Tondela-Viseu

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessing the percentage of patients who adequate read informed consent forms Assess if patients "adequately read" informed consent forms - "adequate reading" was defined by checking all of the following: signing of informed consent form; fulfilment of a questionnaire regarding medical history and drugs; underlining a small sentence added to the orignial version of informed consent form.
Patients not meeting all the defined criteria were considered not to have adequately read the informed consent.		 12 months
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