Bariatric Surgery Candidate Clinical Trial
Official title:
Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
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 |
Verified date | August 2018 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
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. |
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