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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02671734

Enrollment

Registered

2016-02-02

Start date

2014-06-30

Completion date

2014-08-31

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children

Keywords

endoscopy

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALvideo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of Comprehension of Informed Consent Process via a scored scale	Day 1	Structured Interview

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026