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

NCT01578291 | Terminated

• 1 other identifier: NA_00034999
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux

Keywords

Play therapy; Urinary tract infections; Children; Vesicoureteral reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

No intervention

NO INTERVENTION

Parents given routine information by the medical staff.

Parental information

ACTIVE COMPARATOR

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

Behavioral: Parental information; Behavioral: Play therapy

Play Therapy

ACTIVE COMPARATOR

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

Behavioral: Parental information; Behavioral: Play therapy

Interventions

Parental information BEHAVIORAL

An informational brochure indicating the study details

Also known as: Informational materials.

Parental information; Play Therapy

Play therapy BEHAVIORAL

Play therapy with a child life specialist

Also known as: Behavioral therapy, Child life intervention

Parental information; Play Therapy

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children that have been identified to need a voiding cystourethrogram

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Childrens Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux; Urinary Tract Infections

Interventions

Play Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ranjuv Mathews, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 16, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)