Visual Guidelines and Tutoring in Pediatric Urological Surgery

NCT ID: NCT02040389

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-06-30

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).

Conditions

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Hypospadias Undescended Testis Hydrocele Ureteropelvic Junction Stenosis Anxiety

Keywords

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children penile inguinal kidney parents anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Picture book

Intervention Type BEHAVIORAL

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

Standard preoperative education

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

Group Type ACTIVE_COMPARATOR

Standard preoperative education

Intervention Type BEHAVIORAL

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

Interventions

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Picture book

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

Intervention Type BEHAVIORAL

Standard preoperative education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children with indications for penile, inguinal or kidney surgery

Exclusion Criteria

* prior urological procedure (recurrent cases)
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Chertin, MD, Prof.

Role: STUDY_CHAIR

Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel

Locations

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

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18361093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22018934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9662867 (View on PubMed)

Other Identifiers

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92/13

Identifier Type: -

Identifier Source: org_study_id