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

NCT ID: NCT03653962

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate

Keywords

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Multimedia informed consent metabolic surgery Roux-en-Y gastric bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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only informed consent

The first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards.

Group Type ACTIVE_COMPARATOR

non-video group

Intervention Type BEHAVIORAL

video assisted group

The second group got an additional information video presentation and then the same quiz.

Group Type EXPERIMENTAL

video assisted group

Intervention Type BEHAVIORAL

non-video group

Intervention Type BEHAVIORAL

Interventions

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video assisted group

Intervention Type BEHAVIORAL

non-video group

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* illiterate
* previous bariatric surgery
* age \<18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Kutay Saglam

MD, Gastrointestinal Surgery Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Kutay Saglam

Identifier Type: -

Identifier Source: org_study_id