Visual Guidelines and Tutoring in Pediatric Urological Surgery

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Hypospadias; Hydrocele; Undescended Testis; Ureteropelvic Junction Stenosis
• Intervention / Treatment: Behavioral: Picture book; Behavioral: Standard preoperative education

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).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

• prior urological procedure (recurrent cases)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team
Active Comparator: Standard preoperative education; Arm with children undergoing urological procedures and their parents will receive only standard preoperative education	Behavioral: Standard preoperative education; Arm with standard, verbal explaining for a parents about perioperative site/wound view

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Study Chair: Boris Chertin, MD, Prof., Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: children; anxiety; inguinal; penile; kidney parents
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Penile Diseases; Hypospadias; Cryptorchidism
• Other Study ID Numbers: 92/13