Video Consent Form Versus Written Consent Form for ERCP

June 19, 2016 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
          • Zhaoshen Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time for informed consent practices before ERCP
Time Frame: 2 days
2 days
time for extra explanation about ERCP
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
satisfaction degree about the informed consent practices
Time Frame: 2 days
2 days

Other Outcome Measures

Outcome Measure
Time Frame
anxiety level after the informed consent practices
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

June 19, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERCP-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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