NCT02040389

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

January 8, 2014

Last Update Submit

October 26, 2016

Conditions

HypospadiasUndescended TestisHydroceleUreteropelvic Junction StenosisAnxiety

Keywords

childrenpenileinguinalkidney parentsanxiety

Outcome Measures

Primary Outcomes (4)

  • 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

  • Level of parents anxiety

    Measuring of parents anxiety in recovery room after surgery

    Fifteen minutes after surgery

  • Level of parents anxiety

    Measuring of parents anxiety one week after surgery

    Week after surgery

  • Level of parents anxiety

    Measuring of parents anxiety 3-6 weeks after surgery

    Three weeks after surgery

Secondary Outcomes (4)

  • Numbers of parents non-planed calls/visits

    During a week before surgery

  • Numbers of parents non-planed calls/visits

    During 48 hours after surgery

  • Numbers of parents non-planed calls/visits

    0ne week after surgery

  • Numbers of parents non-planed calls/visits

    During 3-6 weeks after surgery

Study Arms (2)

pictures book + standard education

ACTIVE COMPARATOR

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

Standard preoperative education

ACTIVE COMPARATOR

Arm with children undergoing urological procedures and their parents will receive only standard preoperative education

Behavioral: Standard preoperative education

Interventions

Picture bookBEHAVIORAL

Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team

pictures book + standard education
Standard preoperative educationBEHAVIORAL

Arm with standard, verbal explaining for a parents about perioperative site/wound view

Standard preoperative education

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with indications for penile, inguinal or kidney surgery

You may not qualify if:

  • prior urological procedure (recurrent cases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University

Jerusalem, Israel

Location

Related Publications (3)

  • 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.

    PMID: 18361093BACKGROUND

  • 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.

    PMID: 22018934BACKGROUND

  • 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.

    PMID: 9662867BACKGROUND

MeSH Terms

Conditions

HypospadiasCryptorchidismTesticular HydroceleMulticystic renal dysplasia, bilateralAnxiety Disorders

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTesticular DiseasesGonadal DisordersEndocrine System DiseasesMental Disorders

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 20, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2013-11

Locations

IL(1)