Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001701112
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
3/12/2019
Date last updated
3/12/2019
Date data sharing statement initially provided
3/12/2019
Date results information initially provided
3/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the effects of the use of tablet computer and midazolam to reduce surgical stress in pediatric patients by an anesthesiologist
Scientific title
Should We Use a Tablet Computer or Midazolam for Premedication in Pediatric Patients?
Secondary ID [1] 298360 0
None
Universal Trial Number (UTN)
U1111-1234-3680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 313016 0
premedication 313017 0
circumcision prompt 313018 0
inguinal hernia 313019 0
hydrocele 313449 0
undescended testis 313450 0
hypospadias 313451 0
none 314077 0
Condition category
Condition code
Mental Health 311524 311524 0 0
Anxiety
Alternative and Complementary Medicine 312454 312454 0 0
Other alternative and complementary medicine
Anaesthesiology 312455 312455 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we aimed 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 are managed by anesthesiologists.
1- Lego Juniors, Talking Tom Cat, Racing Penguin games were added for ages 4-6 and Subway surfers, Air hockey, Cut the rope games were installed on tablet computer for ages 7-10.
2- Participants are given a tablet computer 30 minutes before the operation. When the operation ends and the room is taken back to the tablet computer. Approximately 30 minutes after the administration of the tablet computer, the pediatric patient is evaluated in his / her room. The pediatric patient is evaluated when leaving the family to go to the operating room. When inhalation induction is performed, its response to the anesthesia mask is evaluated.
3- Participants are given a tablet computer 30 minutes before the operation. When the operation ends and the room is taken back to the tablet computer.
4- The status of the children in the waiting room, their status when leaving the family, and the response to the anesthesia mask during induction were evaluated observationally.
Intervention code [1] 314612 0
Prevention
Comparator / control treatment
In this study, the control group received midazolam 30 minutes before the operation. Midazolam at a dose of 0.5 mg per kg was administered orally.

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

Outcomes
Primary outcome [1] 320229 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] 320229 0
Patients are evaluated by the anesthesiologist 30 minutes after oral midazolam or tablet computer administration.
Primary outcome [2] 320576 0
Acceptance of anesthesia mask was evaluated by anesthesiologists. The acceptance of anesthesia mask are 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] 320576 0
The patient's response to the anesthesia mask is evaluated when inhalation anesthesia is applied with the anesthesia mask.
Secondary outcome [1] 371020 0
After the operation, the anesthesiologist decided for the transfer of the patient from the operating room to the recovery unit once the patient could open their eyes, stick their tongue out, swallow, and lift their heads for 5 seconds with verbal stimuli. The patient was transferred from the recovery unit to their private rooms after complete emergence from general anesthesia as determined by the ability to move all four limbs, take a deep breath, and cough, having a blood pressure differing from preoperative blood pressure by 20 mmHg and a pulse changing by 20%, having gained conscience, having an oxygen saturation above 92% in the room air. The anesthesiologist assessed how long it took for the patients to emerge from anesthesia completely after moving to the recovery unit.
Timepoint [1] 371020 0
The time from entering the recovery unit until the time when the patient was fully awake was recorded as recovery time..
Secondary outcome [2] 372093 0
(These results given below are actually primary outcome. Since there is no section where I can add these primary outcomes above section (maximum 3), So, I added them to the secondary results section.)

When we come in contact with the families of the patients 1 week after the operation, we did study specific questionnaire. In this questionnaire, we questioned the patients whether there are negative behavioral changes such as nightmares, separation anxiety, eating problems, fear of physician after surgery.
Timepoint [2] 372093 0
one week after patients' discharge

Eligibility
Key inclusion criteria
Age 4-10 years
American Society of Anesthesiologists score 1 or 2
children were 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 who 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 were not included in the study.

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 were 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
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
20/05/2019
Date of last data collection
Anticipated
Actual
27/05/2019
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 21539 0
Turkey
State/province [1] 21539 0
Izmir

Funding & Sponsors
Funding source category [1] 302934 0
Self funded/Unfunded
Name [1] 302934 0
unfunded
Country [1] 302934 0
Primary sponsor type
Individual
Name
Dr Behcet Uz Children's Hospital
Address
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] 303164 0
None
Name [1] 303164 0
Address [1] 303164 0
Country [1] 303164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303469 0
DR. BEHÇET UZ CHILD DISEASES AND SURGERY TRAINING AND RESEARCH HOSPITAL CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 303469 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Ethics committee country [1] 303469 0
Turkey
Date submitted for ethics approval [1] 303469 0
16/05/2016
Approval date [1] 303469 0
08/12/2016
Ethics approval number [1] 303469 0
2016/96

Summary
Brief summary
Anxiety is a typical response expected from a child in an unusual circumstance. Pharmacological methods and non-pharmacological methods have been used to reduce the child’s anxiety. We investigated the effects of the pharmacological method of oral midazolam with the non-pharmacological method of playing games on a tablet computer on children with and without anxiety.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93766 0
Dr Kubra Evren Sahin
Address 93766 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Country 93766 0
Turkey
Phone 93766 0
+902324116000
Fax 93766 0
+902324892315
Email 93766 0
[email protected]
Contact person for public queries
Name 93767 0
Dr Kubra Evren Sahin
Address 93767 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Country 93767 0
Turkey
Phone 93767 0
+902324116000
Fax 93767 0
+902324892315
Email 93767 0
[email protected]
Contact person for scientific queries
Name 93768 0
Dr Kubra Evren Sahin
Address 93768 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11 Konak / IZMIR
Country 93768 0
Turkey
Phone 93768 0
+902324116000
Fax 93768 0
+902324892315
Email 93768 0
[email protected]

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 spesific type of analysis for which data are available. It can be used for any purpose.
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3295Study protocol    377677-(Uploaded-24-11-2019-21-28-04)-Study-related document.DOC
3296Ethical approval    377677-(Uploaded-20-07-2019-07-49-37)-Study-related document.pdf
3297Informed consent form    377677-(Uploaded-11-10-2019-08-17-58)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3295Study protocol    377677-(Uploaded-13-01-2020-08-39-38)-Study-related document.doc
3296Ethical approval    377677-(Uploaded-20-07-2019-07-49-37)-Study-related document.pdf
3297Informed consent form    377677-(Uploaded-11-10-2019-08-17-58)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 377677-(Uploaded-11-10-2019-08-19-34)-Basic results summary.pdf
Plain language summaryNo The patients who had anxiety at 30 minutes before ... [More Details]

Documents added automatically
No additional documents have been identified.