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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vesicoureteral Reflux

Intervention / Treatment
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* Behavioral: Parental information
* Behavioral: Play therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Parents given routine information by the medical staff. | |
| Active Comparator: Parental information<br>Parents are provided with an educational brochure of the study and the expectations of the discomfort. | Behavioral: Parental information<br>* An informational brochure indicating the study details<br>* Other names: Informational materials.;Behavioral: Play therapy<br>* Play therapy with a child life specialist<br>* Other names: Child life intervention;|
| Active Comparator: Play Therapy<br>Child and the parents will spend time in the office with the child life therapist undergoing play therapy. | Behavioral: Parental information<br>* An informational brochure indicating the study details<br>* Other names: Informational materials.;Behavioral: Play therapy<br>* Play therapy with a child life specialist<br>* Other names: Child life intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam | 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. | 12 months anticipated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Play therapy, Urinary tract infections, Children, Vesicoureteral reflux