Clinical trial NCT02040389: Visual Guidelines and Tutoring in Pediatric Urological Surgery
Official title: Visual Guidelines and Tutoring in Pediatric Urological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Undescended Testis
Hydrocele
Ureteropelvic Junction Stenosis
Anxiety
Keywords: children
penile
inguinal
kidney parents
anxiety
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

* children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

* prior urological procedure (recurrent cases)

Primary outcomes:
measure: Level of parents anxiety
timeFrame: Thirty minutes before surgery
measure: Level of parents anxiety
timeFrame: Fifteen minutes after surgery
measure: Level of parents anxiety
timeFrame: Week after surgery
measure: Level of parents anxiety
timeFrame: Three weeks after surgery
Secondary outcomes:
measure: Numbers of parents non-planed calls/visits
timeFrame: During a week before surgery
measure: Numbers of parents non-planed calls/visits
timeFrame: During 48 hours after surgery
measure: Numbers of parents non-planed calls/visits
timeFrame: 0ne week after surgery
measure: Numbers of parents non-planed calls/visits
timeFrame: During 3-6 weeks after surgery
Other outcomes:
Locations:
city: Jerusalem,
country: Israel
facility: The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
Study officials:
affiliation: Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
name: Boris Chertin, MD, Prof.
role: STUDY_CHAIR
References:
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. No abstract available.
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.
citation: 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.