NCT02671734

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Huang, Jeannie, M.D. · Individual
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Children

Interventions

Type	Name	Description
BEHAVIORAL	video	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2016-02-02
• Last updated: 2016-02-02