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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02040389
Other study ID # 92/13
Secondary ID
Status Completed
Phase N/A
First received January 8, 2014
Last updated October 26, 2016
Start date March 2014
Est. completion date June 2016

Study information

Verified date November 2013
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 18 Years
Eligibility Inclusion Criteria:

- children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

- prior urological procedure (recurrent cases)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Picture book
Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team
Standard preoperative education
Arm with standard, verbal explaining for a parents about perioperative site/wound view

Locations

Country Name City State
Israel The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University Jerusalem,

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Level of parents anxiety Measuring of parents anxiety in recovery room after surgery Fifteen minutes after surgery No
Primary Level of parents anxiety Measuring of parents anxiety one week after surgery Week after surgery No
Primary Level of parents anxiety Measuring of parents anxiety 3-6 weeks after surgery Three weeks after surgery No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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