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

Vesicoureteral Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01578291
• Other study ID #: NA_00034999
• Status: Terminated
• Phase: N/A
• First received: April 10, 2012
• Last updated: December 7, 2017
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

Behavioral:
• Parental information
An informational brochure indicating the study details
• Play therapy
Play therapy with a child life specialist

Locations

Country	Name	City	State
United States	Johns Hopkins Childrens Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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