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

Children Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02671734
Study type Interventional
Source Huang, Jeannie, M.D.
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date August 2014
View Details
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