Visual Guidelines and Tutoring in Pediatric Urological Surgery

Study Overview
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Brief Summary
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The aim of this study is checking impact of visual guidelines (picture book) and tutoring in pediatric urologic surgery

Detailed Description
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The number of operations in pediatric urology performed on the basis of one day surgery has been increased tremendously over the last years. The shortening of the hospital admission intends to increase the efficacy of the health system, however at the same time puts an additional burdening regarding the postoperative care on the parents of the operated children. The parents often have no or has little experience with regards to the basic medical education. The lack of the proper tutoring in terms of possible complications, normal postoperative period may cause unnecessary patients and parents anxiety, visit to the emergency room or calls to the medical stuff, and in some case delay medical attention which can cause major surgery related complications. Visual guidelines and tutoring of the patients upon surgery may avoid these undesirable effects of the early hospital discharge Patients and methods: The investigators are proposing prospective study of 3 groups of patients which undergo the most often urological surgery Group 1 penile surgery, Group 2 inguinal surgery. Group 3 renal surgery required nephrostomy tube leave or drainage. Each group will be divided into two subgroups (20 patients each) with and without visual tutoring prior to the surgery. Visual tutoring will include the photograph pictures reflecting different stage of the convalescent period following surgery. The parents will be asked to answer on questionnaire regarding the level of anxiety before surgery, immediately after surgery, week and 3-6 months after surgery. The number of parents calls to the hospital staff, emergency or outpatient clinic visit will be recorded and compared between two groups. The statistical analysis will performed utilizing Graph Pad Prism version 5.00 for Windows, (Graph Pad software, San Diego, California, chi square and Fisher test), considering p value of <0.05 as significant).

Official Title
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Visual Guidelines and Tutoring in Pediatric Urological Surgery

Conditions
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Hydrocele, Hypospadias, Undescended Testis, Ureteropelvic Junction Stenosis, Anxiety

Intervention / Treatment
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* Behavioral: Picture book
* Behavioral: Standard preoperative education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with indications for penile, inguinal or kidney surgery Exclusion Criteria: prior urological procedure (recurrent cases)

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pictures book + standard education<br>arm with children undergoing urological procedures and their parents will receive standard preoperative education + pictures book with pictures of surgical wound in different stages of healing | Behavioral: Picture book<br>* Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team<br>|
| Active Comparator: Standard preoperative education<br>Arm with children undergoing urological procedures and their parents will receive only standard preoperative education | Behavioral: Standard preoperative education<br>* Arm with standard, verbal explaining for a parents about perioperative site/wound view<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of parents anxiety | The following parameters will be compared between two groups: level of parents anxiety by questionnaire, numbers of parents calls to the hospital staff and non-planed visits to emergency department/outpatient clinic | Thirty minutes before surgery | 
| Level of parents anxiety | Measuring of parents anxiety in recovery room after surgery | Fifteen minutes after surgery | 
| Level of parents anxiety | Measuring of parents anxiety one week after surgery | Week after surgery | 
| Level of parents anxiety | Measuring of parents anxiety 3-6 weeks after surgery | Three weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of parents non-planed calls/visits | We will note in two groups all non-planned calls/visits before surgery | During a week before surgery | 
| Numbers of parents non-planed calls/visits | We will note in two groups all non-planned calls/visits during 48 hours after surgery | During 48 hours after surgery | 
| Numbers of parents non-planed calls/visits | We will note in two groups all non-planned calls/visits one week after surgery | 0ne week after surgery | 
| Numbers of parents non-planed calls/visits | We will note in two groups of patients all non-planed calls/visits 3-6 weeks after surgery | During 3-6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, penile, inguinal, kidney parents, anxiety