Text Size

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

This study is currently recruiting participants.
Verified April 2012 by Johns Hopkins University
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Vesicoureteral Reflux
 Behavioral: Parental information
Behavioral: Play therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Active Comparator: Play Therapy
Child and the parents will spend time in the office with the child life therapist undergoing play therapy.
 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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578291

Contacts
Contact: Amanda Moatz 410 955 3693 amoatz@jhmi.edu
Contact: Ranjiv Mathews, MD 410 955 3693 rmathew1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Childrens Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Amanda Moatz     410-955-3693     amoatz@jhmi.edu    
Contact: Ranjiv Mathews, MD     410 955 3693     rmathew1@jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ranjuv Mathews, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Ranjiv Mathews, MD, Clinical Adjunct Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01578291     History of Changes
Other Study ID Numbers: NA_00034999
Study First Received: April 10, 2012
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Play therapy
Urinary tract infections
Children
Vesicoureteral reflux

Additional relevant MeSH terms:
Vesico-Ureteral Reflux
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013