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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ranjiv Mathews, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01578291
First received: April 10, 2012
Last updated: April 13, 2012
Last verified: April 2012

April 10, 2012
April 13, 2012
December 2011
December 2012   (final data collection date for primary outcome measure)
Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam [ Time Frame: 12 months anticipated ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01578291 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Vesicoureteral Reflux
  • Behavioral: Parental information
    An informational brochure indicating the study details
    Other Name: Informational materials.
  • Behavioral: Play therapy
    Play therapy with a child life specialist
    Other Names:
    • Behavioral therapy
    • Child life intervention
  • No Intervention: No intervention
    Parents given routine information by the medical staff.
  • Active Comparator: Parental information
    Parents are provided with an educational brochure of the study and the expectations of the discomfort.
    Interventions:
    • Behavioral: Parental information
    • Behavioral: Play therapy
  • Active Comparator: Play Therapy
    Child and the parents will spend time in the office with the child life therapist undergoing play therapy.
    Interventions:
    • Behavioral: Parental information
    • Behavioral: Play therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
2 Years to 10 Years
No
Contact: Amanda Moatz 410 955 3693 amoatz@jhmi.edu
Contact: Ranjiv Mathews, MD 410 955 3693 rmathew1@jhmi.edu
United States
 
NCT01578291
NA_00034999
No
Ranjiv Mathews, MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Ranjuv Mathews, MD Johns Hopkins University
Johns Hopkins University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP