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CompletedNCT02040389Updated Oct 27, 2016

Visual Guidelines and Tutoring in Pediatric Urological Surgery

An interventional study of Picture book and Standard preoperative education in Hypospadias, Undescended Testis and Hydrocele, sponsored by Shaare Zedek Medical Center. Completed at 1 site in Israel. Open to participants aged 2 Months to 18 Years. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
2 Months to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

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).

02

Conditions studied

  • Hypospadias
  • Undescended Testis
  • Hydrocele
  • Ureteropelvic Junction Stenosis
  • Anxiety

Keywords

  • children
  • penile
  • inguinal
  • kidney parents
  • anxiety
03

In context

Hypospadias

123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's enrollment of 120 is above the median of 70 across 97 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children with indications for penile, inguinal or kidney surgery

Exclusion criteria

Exclusion Criteria:

  • prior urological procedure (recurrent cases)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    pictures book + standard education

    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

  • Active comparator
    Standard preoperative education

    Arm with children undergoing urological procedures and their parents will receive only standard preoperative education

    Behavioral: Standard preoperative education

Interventions

  • BehavioralPicture book

    Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team

  • BehavioralStandard preoperative education

    Arm with standard, verbal explaining for a parents about perioperative site/wound view

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Thirty minutes before surgery

  2. Level of parents anxiety

    Measuring of parents anxiety in recovery room after surgery

    Time frame: Fifteen minutes after surgery

  3. Level of parents anxiety

    Measuring of parents anxiety one week after surgery

    Time frame: Week after surgery

  4. Level of parents anxiety

    Measuring of parents anxiety 3-6 weeks after surgery

    Time frame: Three weeks after surgery

Secondary outcomes

  1. Numbers of parents non-planed calls/visits

    We will note in two groups all non-planned calls/visits before surgery

    Time frame: During a week before surgery

  2. Numbers of parents non-planed calls/visits

    We will note in two groups all non-planned calls/visits during 48 hours after surgery

    Time frame: During 48 hours after surgery

  3. Numbers of parents non-planed calls/visits

    We will note in two groups all non-planned calls/visits one week after surgery

    Time frame: 0ne week after surgery

  4. 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

    Time frame: During 3-6 weeks after surgery

07

Study locations

1 site
  • The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
    Jerusalem,, Israel
08

References and documents

Publications

  • Ono S, Oikawa I, Hirabayashi Y, Manabe Y. Preparation of a picture book to support parents and autonomy in preschool children facing day surgery. Pediatr Nurs. 2008 Jan-Feb;34(1):82-3, 88. No abstract available. PubMed 18361093 ↗
  • Nelson CP, Rosoklija I, Grant R, Retik AB. Development and implementation of a photographic atlas for parental instruction and guidance after outpatient penile surgery. J Pediatr Urol. 2012 Oct;8(5):521-6. doi: 10.1016/j.jpurol.2011.09.012. Epub 2011 Oct 20. PubMed 22018934 ↗
  • Moix J, Bassets J, Caelles RM. [Effectiveness of audiovisual materials as a preparation for surgery in pediatric patients]. Cir Pediatr. 1998 Jan;11(1):25-9. Spanish. PubMed 9662867 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Feb 2015 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2014
First posted
Jan 20, 2014
Start
Mar 2014
Primary completionActual
Feb 2015
CompletionActual
Jun 2016
Last update
Oct 27, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02040389
Responsible party
Sponsor
First posted
Jan 20, 2014
Start date
Mar 2014
Primary completion
Feb 2015
Completion
Jun 2016
Last update
Oct 27, 2016

Study contacts

Boris Chertin, MD, Prof.
study chair · Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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