Vesicoureteral RefluxNCT01578291
Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
A study testing Parental information and Play therapy in people with Vesicoureteral Reflux, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- Parental information and Play therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children that have been identified to need a voiding cystourethrogram
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Childrens Center
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Vesicoureteral Reflux
- Being tested
- Parental information, Play therapy
- Keywords
- Play therapy, Urinary tract infections, Children, Vesicoureteral reflux
- Medical subject headings
- Vesico-Ureteral Reflux, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental informationBehavioural
Also called Informational materials.
An informational brochure indicating the study details
Play therapyBehavioural
Also called Behavioral therapy, Child life intervention
Play therapy with a child life specialist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Parental information; Behavioral: Play therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Recruitment was not on target, evised AAP guidelines may have contributed to the decrease in the number of potential participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranjuv Mathews, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578291
- Sponsor's protocol ID
- NA_00034999
- Status last verified
- Dec 2017
- First submitted
- 10 Apr 2012
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
- ClinicalTrials.gov ID
- NCT01578291
- Acronym / sponsor ID
- NA_00034999
- Conditions
- Vesicoureteral Reflux
- Keywords
- Play therapy, Urinary tract infections, Children, Vesicoureteral reflux
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was not on target, evised AAP guidelines may have contributed to the decrease in the number of potential participants
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Parents given routine information by the medical staff. |
| Parental information | Active comparator | Behavioral: Parental information, Behavioral: Play therapyParents are provided with an educational brochure of the study and the expectations of the discomfort. |
| Play Therapy | Active comparator | Behavioral: Parental information, Behavioral: Play therapyChild and the parents will spend time in the office with the child life therapist undergoing play therapy. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children that have been identified to need a voiding cystourethrogram
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental informationAlso: Informational materials.An informational brochure indicating the study details | Behavioural | Parental information, Play Therapy |
| Play therapyAlso: Behavioral therapy, Child life interventionPlay therapy with a child life specialist | Behavioural | Parental information, Play Therapy |
Primary outcome
Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam
Time frame: 12 months anticipated
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.
Results and safety
The study was stopped early (reason given: Recruitment was not on target, evised AAP guidelines may have contributed to the decrease in the number of potential participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjuv Mathews, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental information and Play therapy in people with Vesicoureteral Reflux, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was not on target, evised AAP guidelines may have contributed to the decrease in the number of potential participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam (time frame: 12 months anticipated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.