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

NCT ID: NCT01578291

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

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.

Conditions

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Vesicoureteral Reflux

Keywords

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Play therapy Urinary tract infections Children Vesicoureteral reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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No intervention

Parents given routine information by the medical staff.

Group Type NO_INTERVENTION

No interventions assigned to this group

Parental information

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

Group Type ACTIVE_COMPARATOR

Parental information

Intervention Type BEHAVIORAL

An informational brochure indicating the study details

Play therapy

Intervention Type BEHAVIORAL

Play therapy with a child life specialist

Play Therapy

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

Group Type ACTIVE_COMPARATOR

Parental information

Intervention Type BEHAVIORAL

An informational brochure indicating the study details

Play therapy

Intervention Type BEHAVIORAL

Play therapy with a child life specialist

Interventions

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Parental information

An informational brochure indicating the study details

Intervention Type BEHAVIORAL

Play therapy

Play therapy with a child life specialist

Intervention Type BEHAVIORAL

Other Intervention Names

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Informational materials. Behavioral therapy Child life intervention

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ranjuv Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Childrens Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00034999

Identifier Type: -

Identifier Source: org_study_id