Visual Guidelines and Tutoring in Pediatric Urological Surgery

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02040389
Collaborator
(none)
120
1
2
27
4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Picture book
  • Behavioral: Standard preoperative education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Guidelines and Tutoring in Pediatric Urological Surgery
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Level of parents anxiety [Thirty minutes before surgery]

    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

  2. Level of parents anxiety [Fifteen minutes after surgery]

    Measuring of parents anxiety in recovery room after surgery

  3. Level of parents anxiety [Week after surgery]

    Measuring of parents anxiety one week after surgery

  4. Level of parents anxiety [Three weeks after surgery]

    Measuring of parents anxiety 3-6 weeks after surgery

Secondary Outcome Measures

  1. Numbers of parents non-planed calls/visits [During a week before surgery]

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

  2. Numbers of parents non-planed calls/visits [During 48 hours after surgery]

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

  3. Numbers of parents non-planed calls/visits [0ne week after surgery]

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

  4. Numbers of parents non-planed calls/visits [During 3-6 weeks after surgery]

    We will note in two groups of patients all non-planed calls/visits 3-6 weeks after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children with indications for penile, inguinal or kidney surgery
Exclusion Criteria:
  • prior urological procedure (recurrent cases)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University Jerusalem, Israel

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT02040389
Other Study ID Numbers:
  • 92/13
First Posted:
Jan 20, 2014
Last Update Posted:
Oct 27, 2016
Last Verified:
Nov 1, 2013
Keywords provided by Shaare Zedek Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2016