Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.

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Key information

Conditions

Children

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

IC = informed consent

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
Had to be undergoing pediatric endoscopy.
English speaking

Exclusion criteria

None.

Treatment and study plan

Video

Behavioral

Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.

Primary outcomes

Evaluation of Comprehension of Informed Consent Process via a scored scale

Time frame: Day 1

Structured Interview

Sponsors and collaborators

Lead sponsor

Huang, Jeannie, M.D.

Indiv

Registry information

Official study title

Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 2, 2016
Registry last updated: Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed