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Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content

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.
 
ClinicalTrials.gov Identifier: NCT03653962
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Kutay Saglam, Inonu University

Brief Summary:
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Behavioral: video assisted group Behavioral: non-video group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: only informed consent
The first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards.
Behavioral: non-video group
Experimental: video assisted group
The second group got an additional information video presentation and then the same quiz.
Behavioral: video assisted group
Behavioral: non-video group



Primary Outcome Measures :
  1. Questionnaire [ Time Frame: six months ]

    In the video group : verbal-written consent + video presentation In the conventional consent group: only verbal-written consent

    The video consisted of a summary of the written informed consent. Questionnaire consist of 15 questions quiz was given to both groups. Each question was rated on 15 points. 1point = bad score means don't understand informed consent. 15 point = full score means good understanding.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • being a being bariatric metabolic surgery candidate according to international guidelines

Exclusion Criteria:

  • illiterate
  • previous bariatric surgery
  • age <18

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Responsible Party: Kutay Saglam, MD, Gastrointestinal Surgery Fellow, Inonu University
ClinicalTrials.gov Identifier: NCT03653962    
Other Study ID Numbers: Kutay Saglam
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kutay Saglam, Inonu University:
Multimedia
informed consent
metabolic surgery
Roux-en-Y gastric bypass