Video Consent Form Versus Written Consent Form for ERCP

Naval Military Medical University

Status: Unknown

Conditions: Consent Forms of ERCP

Treatments: Procedure: written informed consent; Procedure: video+written informed consent

Study type: Interventional

Funder types: Other

Identifiers

NCT02810379

ERCP-1

Details and patient eligibility

About

To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All inpatients who will receive ERCP

Exclusion criteria

• under 18 years or more than 70 years
• pregnancy or breast-feeding women
• circulatory and respiratory disorders
• mental illness

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

written informed consent

Placebo Comparator group

Description:

participants read the written informed consent documents befor ERCP

Treatment:

Procedure: written informed consent

video+written informed consent

Experimental group

Description:

participants watch a video about the ERCP and read the written informed consent documents before ERCP

Treatment:

Procedure: video+written informed consent