Trial record 3 of 40 for:    Open Studies | "Testicular Diseases"

Visual Guidelines and Tutoring in Pediatric Urological Surgery

This study is not yet open for participant recruitment.
Verified November 2013 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT02040389
First received: January 8, 2014
Last updated: January 15, 2014
Last verified: November 2013
  Purpose

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


Condition Intervention
Hypospadias
Undescended Testis
Hydrocele
Ureteropelvic Junction Stenosis
Anxiety
Behavioral: Picture book
Behavioral: Standard preoperative education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Guidelines and Tutoring in Pediatric Urological Surgery

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Level of parents anxiety [ Time Frame: Thirty minutes before surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Fifteen minutes after surgery ] [ Designated as safety issue: No ]
    Measuring of parents anxiety in recovery room after surgery

  • Level of parents anxiety [ Time Frame: Week after surgery ] [ Designated as safety issue: No ]
    Measuring of parents anxiety one week after surgery

  • Level of parents anxiety [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: No ]
    Measuring of parents anxiety 3-6 weeks after surgery


Secondary Outcome Measures:
  • Numbers of parents non-planed calls/visits [ Time Frame: During a week before surgery ] [ Designated as safety issue: No ]
    We will note in two groups all non-planned calls/visits before surgery

  • Numbers of parents non-planed calls/visits [ Time Frame: During 48 hours after surgery ] [ Designated as safety issue: No ]
    We will note in two groups all non-planned calls/visits during 48 hours after surgery

  • Numbers of parents non-planed calls/visits [ Time Frame: 0ne week after surgery ] [ Designated as safety issue: No ]
    We will note in two groups all non-planned calls/visits one week after surgery

  • Numbers of parents non-planed calls/visits [ Time Frame: During 3-6 weeks after surgery ] [ Designated as safety issue: No ]
    We will note in two groups of patients all non-planed calls/visits 3-6 weeks after surgery


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

  • prior urological procedure (recurrent cases)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040389

Contacts
Contact: Stanislav Kocherov, MD +972-2-6666972 aflek1@yahoo.com
Contact: Boris Chertin, MD, Prof. +972-2-6555560 boris.chertin@gmail.com

Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02040389     History of Changes
Other Study ID Numbers: 92/13
Study First Received: January 8, 2014
Last Updated: January 15, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
children
penile
inguinal
kidney parents
anxiety

Additional relevant MeSH terms:
Testicular Diseases
Anxiety Disorders
Cryptorchidism
Hypospadias
Testicular Hydrocele
Mental Disorders
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Penile Diseases

ClinicalTrials.gov processed this record on April 17, 2014