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

August 29, 2018 updated by: Kutay Saglam, Inonu University

Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • illiterate
  • previous bariatric surgery
  • age <18

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: non-video group
Behavioral: video assisted group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Collaborators and Investigators

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

Sponsor

Inonu University

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 (Actual)

October 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kutay Saglam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Bariatric Surgery Candidate

Clinical Trials on non-video group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe