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Completed

NCT Number: NCT02040389

Visual Guidelines and Tutoring in Pediatric Urological Surgery

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children with indications for penile, inguinal or kidney surgery

Exclusion criteria

  • prior urological procedure (recurrent cases)

Treatment and study plan

Picture book

Behavioral

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

Standard Preoperative Education

Behavioral

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

Primary outcomes

  1. Level of parents anxiety

    Time frame: 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

    Time frame: Fifteen minutes after surgery

    Measuring of parents anxiety in recovery room after surgery

  3. Level of parents anxiety

    Time frame: Week after surgery

    Measuring of parents anxiety one week after surgery

  4. Level of parents anxiety

    Time frame: Three weeks after surgery

    Measuring of parents anxiety 3-6 weeks after surgery

Secondary outcomes

  1. Numbers of parents non-planed calls/visits

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During 3-6 weeks after surgery

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

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 20, 2014
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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