HypospadiasNCT02040389
Visual Guidelines and Tutoring in Pediatric Urological Surgery
A study testing Picture book and Standard preoperative education in people with Hypospadias and Undescended Testis, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The aim of this study is checking impact of visual guidelines (picture book) and tutoring in pediatric urologic surgery Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Hypospadias, Undescended Testis, Hydrocele
- What is being tested?
- Picture book and Standard preoperative education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with indications for penile, inguinal or kidney surgery
Who cannot join
- prior urological procedure (recurrent cases)
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Department of Pediatric Urology, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University
Jerusalem
About this study
The aim of this study is checking impact of visual guidelines (picture book) and tutoring in pediatric urologic surgery
Read the 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).
- Being tested
- Picture book, Standard preoperative education
- Keywords
- children, penile, inguinal, kidney parents, anxiety
- Medical subject headings
- Hypospadias, Cryptorchidism, Testicular Hydrocele, Multicystic renal dysplasia, bilateral, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picture bookBehavioural
Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team
Standard preoperative educationBehavioural
Arm with standard, verbal explaining for a parents about perioperative site/wound view
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Picture book |
| Standard preoperative education | Active comparator | Arm with children undergoing urological procedures and their parents will receive only standard preoperative education Receives: Behavioral: Standard preoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Thirty minutes before surgery
Level of parents anxiety
Measuring of parents anxiety in recovery room after surgery
Measured: Fifteen minutes after surgery
Level of parents anxiety
Measuring of parents anxiety one week after surgery
Measured: Week after surgery
Level of parents anxiety
Measuring of parents anxiety 3-6 weeks after surgery
Measured: Three weeks after surgery
Secondary outcomes (4)
Numbers of parents non-planed calls/visits
We will note in two groups all non-planned calls/visits before surgery
Measured: During a week before surgery
Numbers of parents non-planed calls/visits
We will note in two groups all non-planned calls/visits during 48 hours after surgery
Measured: During 48 hours after surgery
Numbers of parents non-planed calls/visits
We will note in two groups all non-planned calls/visits one week after surgery
Measured: 0ne week after surgery
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
Measured: During 3-6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Chertin, MD, Prof., Study chair, Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040389
- Sponsor's protocol ID
- 92/13
- Status last verified
- Nov 2013
- First submitted
- 8 Jan 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18361093Nelson 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.
PubMed 22018934Moix 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.
PubMed 9662867
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Guidelines and Tutoring in Pediatric Urological Surgery
- ClinicalTrials.gov ID
- NCT02040389
- Acronym / sponsor ID
- 92/13
- Keywords
- children, penile, inguinal, kidney parents, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pictures book + standard education | Active comparator | Behavioral: Picture bookarm 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 |
| Standard preoperative education | Active comparator | Behavioral: Standard preoperative educationArm with children undergoing urological procedures and their parents will receive only standard preoperative education |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with indications for penile, inguinal or kidney surgery
Key exclusion criteria (1 listed)
- prior urological procedure (recurrent cases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picture bookArm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team | Behavioural | pictures book + standard education |
| Standard preoperative educationArm with standard, verbal explaining for a parents about perioperative site/wound view | Behavioural | Standard preoperative education |
Primary outcome
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
Level of parents anxiety
Time frame: Fifteen minutes after surgery
Measuring of parents anxiety in recovery room after surgery
Level of parents anxiety
Time frame: Week after surgery
Measuring of parents anxiety one week after surgery
Level of parents anxiety
Time frame: Three weeks after surgery
Measuring of parents anxiety 3-6 weeks after surgery
4 secondary outcomes
Numbers of parents non-planed calls/visits
Time frame: During a week before surgery
Numbers of parents non-planed calls/visits
Time frame: During 48 hours after surgery
Numbers of parents non-planed calls/visits
Time frame: 0ne week after surgery
Numbers of parents non-planed calls/visits
Time frame: During 3-6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Background: PubMed 18361093Ono 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.
- Background: PubMed 22018934Nelson 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.
- Background: PubMed 9662867Moix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Chertin, MD, Prof. study chair
Head, The Department of Pediatric Urology, Shaare Zedek Medical Center, Clinical Professor in Surgery/Urology, Faculty of Medicine, Hebrew University, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picture book and Standard preoperative education in people with Hypospadias and Undescended Testis, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of parents anxiety (time frame: Thirty minutes before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.