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NCT03653962 Clinical Trial

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

Bariatric Surgery Candidate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03653962
Other study ID # Kutay Saglam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date March 2017

Study information
Verified date August 2018
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date March 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- illiterate

- previous bariatric surgery

- age <18

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• video assisted group

• non-video group

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Inonu University

Outcome
Type Measure Description Time frame Safety issue
Primary Questionnaire 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
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