Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram

Not Applicable

Terminated

• Conditions: Vesicoureteral Reflux
• Interventions: Behavioral: Parental information; Behavioral: Play therapy

• Registration Number: NCT01578291
• Lead Sponsor: Johns Hopkins University

Brief Summary

Hypothesis: The use of parent education and medical play will be able to reduce patient discomfort with potential uncomfortable medical procedures.

Children that have urinary tract infections and those diagnosed with vesicoureteral reflux undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow vesicoureteral reflux. For many children and parents this can lead to considerable distress. Pre-procedure preparation can potentially reduce anxiety and improve overall experience with the procedure.

Detailed Description

Children that are evaluated medically and found to need a VCUG would be eligible for participation in this study. Children would be randomized to having play therapy or a parental education brochure. The study would have no impact on the child recieving the state of the art medical care.

Play therapy involves having the child play through the process of the study with a child life therapist, in an effort to prepare the child for the procedure. Parents/patients will be given a pre and post procedure evaluation form to objectively categorize the parental/patient perception of the experience with the study.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Children that have been identified to need a voiding cystourethrogram

Exclusion Criteria

• Significant medical conditions that preclude child from being able to understand play therapy or have been identified in the past to have so much discomfort from prior studies as to not be able to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parental information	Play therapy	Parents are provided with an educational brochure of the study and the expectations of the discomfort.
Play Therapy	Play therapy	Child and the parents will spend time in the office with the child life therapist undergoing play therapy.
Play Therapy	Parental information	Child and the parents will spend time in the office with the child life therapist undergoing play therapy.
Parental information	Parental information	Parents are provided with an educational brochure of the study and the expectations of the discomfort.

Primary Outcome Measures

Name	Time	Method
Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam	12 months anticipated	Medical play therapy could potentially reduce parental and pateint anxiety when used for preparing children for medical procedures. This study is designed to identify if play therapy can lead to reduction in parental and pateint anxiety with voiding cystourethrogram - a commonly performed test for the evaluation of children with urinary tract infections.

Trial Locations

Locations (1)

Johns Hopkins Childrens Center; 🇺🇸 Baltimore, Maryland, United States