search
Back to results

Visual Guidelines and Tutoring in Pediatric Urological Surgery

Primary Purpose

Hypospadias, Undescended Testis, Hydrocele

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Picture book
Standard preoperative education
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias focused on measuring children, penile, inguinal, kidney parents, anxiety

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

  • prior urological procedure (recurrent cases)

Sites / Locations

  • The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pictures book + standard education

Standard preoperative education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Level of parents anxiety
Measuring of parents anxiety in recovery room after surgery
Level of parents anxiety
Measuring of parents anxiety one week after surgery
Level of parents anxiety
Measuring of parents anxiety 3-6 weeks after surgery

Secondary Outcome Measures

Numbers of parents non-planed calls/visits
We will note in two groups all non-planned calls/visits 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
Numbers of parents non-planed calls/visits
We will note in two groups all non-planned calls/visits one 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

Full Information

First Posted
January 8, 2014
Last Updated
October 26, 2016
Sponsor
Shaare Zedek Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02040389
Brief Title
Visual Guidelines and Tutoring in Pediatric Urological Surgery
Official Title
Visual Guidelines and Tutoring in Pediatric Urological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias, Undescended Testis, Hydrocele, Ureteropelvic Junction Stenosis, Anxiety
Keywords
children, penile, inguinal, kidney parents, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pictures book + standard education
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard preoperative education
Arm Type
Active Comparator
Arm Description
Arm with children undergoing urological procedures and their parents will receive only standard preoperative education
Intervention Type
Behavioral
Intervention Name(s)
Picture book
Intervention Description
Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team
Intervention Type
Behavioral
Intervention Name(s)
Standard preoperative education
Intervention Description
Arm with standard, verbal explaining for a parents about perioperative site/wound view
Primary Outcome Measure Information:
Title
Level of parents anxiety
Description
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
Title
Level of parents anxiety
Description
Measuring of parents anxiety in recovery room after surgery
Time Frame
Fifteen minutes after surgery
Title
Level of parents anxiety
Description
Measuring of parents anxiety one week after surgery
Time Frame
Week after surgery
Title
Level of parents anxiety
Description
Measuring of parents anxiety 3-6 weeks after surgery
Time Frame
Three weeks after surgery
Secondary Outcome Measure Information:
Title
Numbers of parents non-planed calls/visits
Description
We will note in two groups all non-planned calls/visits before surgery
Time Frame
During a week before surgery
Title
Numbers of parents non-planed calls/visits
Description
We will note in two groups all non-planned calls/visits during 48 hours after surgery
Time Frame
During 48 hours after surgery
Title
Numbers of parents non-planed calls/visits
Description
We will note in two groups all non-planned calls/visits one week after surgery
Time Frame
0ne week after surgery
Title
Numbers of parents non-planed calls/visits
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children with indications for penile, inguinal or kidney surgery Exclusion Criteria: prior urological procedure (recurrent cases)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Chertin, MD, Prof.
Organizational Affiliation
Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
City
Jerusalem,
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
18361093
Citation
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.
Results Reference
background
PubMed Identifier
22018934
Citation
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.
Results Reference
background
PubMed Identifier
9662867
Citation
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.
Results Reference
background

Learn more about this trial

Visual Guidelines and Tutoring in Pediatric Urological Surgery

We'll reach out to this number within 24 hrs