Status:

COMPLETED

Improving Informed Consent in Pediatric Endoscopy

Lead Sponsor:

Children's Hospital of Philadelphia

Collaborating Sponsors:

Midwestern University

Conditions:

Informed Consent

Procedural State Anxiety

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing...

Detailed Description

Two hundred first-time upper endoscopy patients from The Children's Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized...

Eligibility Criteria

Inclusion

  • Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)
  • Subject gives consent to participate
  • Child of parent does not have a planned endoscopy intervention.

Exclusion

  • Does not speak or understand English
  • Does not give consent to participate
  • Does not complete consent instrument at a minimum during study

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT00899392

Start Date

September 1 2008

End Date

March 1 2009

Last Update

July 30 2013

Active Locations (1)

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Chidren's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104