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Trial registered on ANZCTR


Registration number
ACTRN12620000750987
Ethics application status
Approved
Date submitted
3/02/2020
Date registered
21/07/2020
Date last updated
21/04/2021
Date data sharing statement initially provided
21/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of the use of tablet computer and midazolam to suppress surgical stress of children
Scientific title
The effect of using tablet computer on surgical stress

.
Secondary ID [1] 300416 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety
 316065 0
hydrocele 316066 0
circumcision prompt 316068 0
inguinal hernia 316069 0
undescended testis 316070 0
hypospadias 316071 0
Condition category
Condition code
Mental Health 314337 314337 0 0
Anxiety
Alternative and Complementary Medicine 314338 314338 0 0
Other alternative and complementary medicine
Anaesthesiology 314339 314339 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the study, we aim to compare the effects of oral midazolam and tablet computer for premedication in patients with anxiety and non-anxiety in children planned for operations under general anesthesia with the diagnosis of circumcision desire, inguinal hernia, hydrocele, and undescended testes. All these interventions will be managed by anesthesiologists.
1- Lego Juniors, Talking Tom Cat, Racing Penguin, Subway surfers, Air hockey, Cut the Rope games will be offered for children ages 4-10.
2- Participants will be given a tablet computer 30 minutes before the operation. After that 30 minutes, the pediatric patient will be evaluated in his/her room. And then, the pediatric patient will be re-evaluated when leaving the family to go to the operating room. Finally, when inhalation induction is performed, its response to the anesthesia mask of the pediatric patient will be assessed again.

When the child who is given a tablet computer to play games is seen by the nurse that the child does not play games with the tablet computer, this child is excluded from the study. When a child given peroral midazolam does not agree to take midazolam or is seen by the nurse, who is removed from the mouth, this child is excluded from the study.
Intervention code [1] 316711 0
Prevention
Intervention code [2] 317069 0
Treatment: Drugs
Comparator / control treatment
In this study, the control group will receive midazolam 30 minutes before the operation. Midazolam at a dose of 0.5 mg per kg will be administered orally.

In our country, when midazolam does not have oral tablet, sublingual and oral syrup form, we will prepare for Midazolam ampoule is mixed orally with 0.5 mg/kg cherry juice and given 5cc in total.
Control group
Active

Outcomes
Primary outcome [1] 322708 0
Anxiety levels in the waiting room were evaluated 30 minutes after taking oral midazolam or tablet computer. The patients were evaluated by the anesthesiologist and scored according to their condition.
Point 1- Sleeping during the exam
Point 2- Those awake and calm during the examination
Point 3- Children who are nervous during the examination but can communicate
Point 4- Children who are crying, stressed or have no dialogue during the examination
Timepoint [1] 322708 0
Patients will be evaluated by the anesthesiologist 30 minutes after oral midazolam or tablet computer administration.
Primary outcome [2] 322709 0
Acceptance of the anesthesia masks will be evaluated by anesthesiologists. The acceptance of the anesthesia mask is scored.
Point 1- Children who easily accept the anesthesia mask
Point 2- Children with mild
Point 3- resistance to anesthesia mask
Point 4- Resistant crying children who do not accept the anesthesia mask
Timepoint [2] 322709 0
The patient's response to the anesthesia mask will be evaluated when inhalation anesthesia is applied with the anesthesia mask.
Primary outcome [3] 324401 0
After the operation the patient will sent to the post-anesthesia care unit by the anesthesiologist. The patient will sent to his room if he can lift his head for 5 seconds, open his eyes, pull out his tongue and swallow with the verbal warning, The time spent in post-anesthesia care unit will recorded as recovery time.
Timepoint [3] 324401 0
Recovery time will be evaluated after the patient arrives at post-anesthesia care unit.
Secondary outcome [1] 379380 0
When we come in contact with the families of the patients 1 week after the operation, we will make specific questionnaire. In that questionnaire, we will question the patients whether there are negative behavioral changes such as nightmares, separation anxiety, eating problems, fear of physician after surgery.
The questionnaire used here is "Changes in Children's Behavior After Hospitalization". This questionnaire was not specifically designed for this study.
Timepoint [1] 379380 0
When we come in contact with the families of the patients 1 week after the operation,

Eligibility
Key inclusion criteria
Age 4-10 years
American Society of Anesthesiologists score 1 or 2
Children will be anesthetized for the first time for surgical procedures due to one of the following conditions: circumcision, inguinal hernia, hydrocele, undescended testis, hypospadias.
Minimum age
4 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be included some circumstances where those had previous surgery, motor, and mental retardation, or chronic diseases, had been using psychiatric medication, had been planned to undergo more than one operation in the same session, had emergency surgery, or had an ASA score of 3 or 4.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients in the oral midazolam and tablet computer groups will be identified using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics were presented as mean, standard deviation, median, minimum, maximum, frequency, and percentage. The normal distribution of the continuous variables was tested with the Kolmogorov-Smirnov test. Mann-Whitney U test was used to compare the quantitative data. Chi-square test was used to analyze qualitative data. The SPSS software (SPSS Inc., Chicago, USA) was used for statistical analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2020
Actual
10/08/2020
Date of last participant enrolment
Anticipated
10/09/2020
Actual
11/09/2020
Date of last data collection
Anticipated
10/09/2020
Actual
17/09/2020
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 22287 0
Turkey
State/province [1] 22287 0
Izmir

Funding & Sponsors
Funding source category [1] 304837 0
Self funded/Unfunded
Name [1] 304837 0
Country [1] 304837 0
Primary sponsor type
Hospital
Name
University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Address
University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Country
Turkey
Secondary sponsor category [1] 305170 0
None
Name [1] 305170 0
Address [1] 305170 0
Country [1] 305170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305247 0
University of Health Sciences Izmir Dr. Behcet Uz Child Disease and Pediatric Surgery Training and Research Hospital.
Ethics committee address [1] 305247 0
Ethics committee country [1] 305247 0
Turkey
Date submitted for ethics approval [1] 305247 0
16/05/2016
Approval date [1] 305247 0
08/12/2016
Ethics approval number [1] 305247 0
2016/96

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99758 0
Dr Kubra Evren Sahin
Address 99758 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Country 99758 0
Turkey
Phone 99758 0
+902324116000
Fax 99758 0
+902324892315
Email 99758 0
kubra.evrensahin@saglik.gov.tr
Contact person for public queries
Name 99759 0
Kubra Evren Sahin
Address 99759 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District,
Sezer Dogan Street, No:11 Konak / IZMIR
Country 99759 0
Turkey
Phone 99759 0
+902324116000
Fax 99759 0
+902324892315
Email 99759 0
kubra.evrensahin@saglik.gov.tr
Contact person for scientific queries
Name 99760 0
Kubra Evren Sahin
Address 99760 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District,
Sezer Dogan Street, No:11 Konak / IZMIR
Country 99760 0
Turkey
Phone 99760 0
+902324116000
Fax 99760 0
+902324892315
Email 99760 0
kubra.evrensahin@saglik.gov.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data related to the work that the editors want will be shared.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Any one who wants to reach could reach one.
Available for what types of analyses?
There is no specific type of analysis for which data are available. It can be used for any purpose.
How or where can data be obtained?
kubraevren@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6696Study protocol    379175-(Uploaded-03-02-2020-06-14-26)-Study-related document.doc
6697Informed consent form    379175-(Uploaded-03-02-2020-06-15-26)-Study-related document.pdf
6698Ethical approval    379175-(Uploaded-03-02-2020-06-16-09)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.