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

Primary Purpose

Vesicoureteral Reflux

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parental information
Play therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesicoureteral Reflux focused on measuring Play therapy, Urinary tract infections, Children, Vesicoureteral reflux

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Childrens Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

No intervention

Parental information

Play Therapy

Arm Description

Parents given routine information by the medical staff.

Parents are provided with an educational brochure of the study and the expectations of the discomfort.

Child and the parents will spend time in the office with the child life therapist undergoing play therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2012
Last Updated
December 7, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01578291
Brief Title
Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
Official Title
Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was not on target, evised AAP guidelines may have contributed to the decrease in the number of potential participants
Study Start Date
December 2011 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux
Keywords
Play therapy, Urinary tract infections, Children, Vesicoureteral reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Parents given routine information by the medical staff.
Arm Title
Parental information
Arm Type
Active Comparator
Arm Description
Parents are provided with an educational brochure of the study and the expectations of the discomfort.
Arm Title
Play Therapy
Arm Type
Active Comparator
Arm Description
Child and the parents will spend time in the office with the child life therapist undergoing play therapy.
Intervention Type
Behavioral
Intervention Name(s)
Parental information
Other Intervention Name(s)
Informational materials.
Intervention Description
An informational brochure indicating the study details
Intervention Type
Behavioral
Intervention Name(s)
Play therapy
Other Intervention Name(s)
Behavioral therapy, Child life intervention
Intervention Description
Play therapy with a child life specialist
Primary Outcome Measure Information:
Title
Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam
Description
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.
Time Frame
12 months anticipated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjuv Mathews, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Childrens Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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