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Video Consent Form Versus Written Consent Form for ERCP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02810379
Recruitment Status : Unknown
Verified June 2016 by Zhaoshen Li, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Consent Forms of ERCP Procedure: written informed consent Procedure: video+written informed consent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Combination of Video and Written Information Provides the Patient With a More Comprehensive Level of Knowledge About Endoscopic Retrograde Cholangiopancreatography: Study Protocol for Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017

Arm Intervention/treatment
Placebo Comparator: written informed consent
participants read the written informed consent documents befor ERCP
Procedure: written informed consent
Experimental: video+written informed consent
participants watch a video about the ERCP and read the written informed consent documents before ERCP
Procedure: video+written informed consent

Primary Outcome Measures :
  1. time for informed consent practices before ERCP [ Time Frame: 2 days ]
  2. time for extra explanation about ERCP [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. satisfaction degree about the informed consent practices [ Time Frame: 2 days ]

Other Outcome Measures:
  1. anxiety level after the informed consent practices [ Time Frame: 2 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02810379

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Contact: Zhaoshen Li, MD +86-21-25070552
Contact: Yu Bai, MD +86-13564665324

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Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Zhaoshen Li, MD         
Sponsors and Collaborators
Changhai Hospital
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Principal Investigator: Zhaoshen Li, MD Changhai Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital Identifier: NCT02810379    
Other Study ID Numbers: ERCP-1
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Keywords provided by Zhaoshen Li, Changhai Hospital:
informed consent