Visual Guidelines and Tutoring in Pediatric Urological Surgery

Anxiety Clinical Trial

Official title:

Visual Guidelines and Tutoring in Pediatric Urological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040389
• Other study ID #: 92/13
• 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

Related Conditions & MeSH terms

• Anxiety
• Cryptorchidism
• Hydrocele
• Hypospadias
• Undescended Testis
• Ureteropelvic Junction Stenosis

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