Determining the effect of using game software on the score of anxiety before surgery in children aged 5-11 years
Design
In this clinical trial, 70 children who are candidates for surgery in the first stage are easily selected and available through the list of surgeries, and in the next stage, they are randomly placed in one of two control or test groups. Study is a blind.
Settings and conduct
The study site is the operating room of Imam Hossein Hospital in Isfahan. The research is a single blind that the statistical analyst does not know about the study groups.
Participants/Inclusion and exclusion criteria
Entry requirements:
At least one parent of the child is present.
No history of surgery in the past.
Have the necessary vigilance to the extent that it does not prevent research.
Physical ability to play with game and educational software.
No history of disease (mental, epilepsy, Down syndrome, mental disability).
Complete consent to participate in the study.
Do not take anti-anxiety drugs based on the doctor's instructions in the file.
No entry conditions.
The child's unwillingness to play with the software.
Severe pain before intervention.
Emergency surgery.
Intervention groups
Children aged 5-11 years are considered as candidates for surgery and according to the inclusion criteria, they are randomly assigned to one of the two control and test groups.
Children in the intervention group play for 15 minutes, half an hour before surgery, and children in the control group play with toys and do not play with software. Anxiety levels are measured before and after the intervention (5 minutes before the child is transferred from the waiting room to the operating room).
Main outcome variables
Anxiety score before surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N10
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-25, 1400/08/03
Expected recruitment end date
2021-11-24, 1400/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using game application on anxiety before surgery in children aged 5-11 years
Public title
The effect of using game application on anxiety before surgery in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Child 11-5 years
At least one parent of the child is present
No history of surgery in the past
Have the necessary vigilance to the extent that it does not prevent research
Physical ability to play with game and educational software
No history of disease (mental, epilepsy, Down syndrome, mental disability)
Complete consent to participate in the study
Do not take anti-anxiety drugs based on the doctor's instructions in the file
Exclusion criteria:
The child's unwillingness to play with the software
Severe pain before intervention
Emergency surgery
Age
From 5 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the available samples are selected from the list of surgeries according to the inclusion criteria, and then the block randomization method is used. Blocking to balance the number of samples assigned to groups. The size of the blocks is equal and will be in the form of six blocks. We use random location software for randomization. In this method, random sequences created by random location software are recorded on the cards and the cards are placed in black letter envelopes and on the outer surface of the envelopes, the number of people entering the study is written and then In the order in which they enter the study, the envelopes are opened to determine which group they belong to.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst is unaware of which group each sample belongs to
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing, Management and Rehabilitation - Isfahan University of Med
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.125
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
In this study, anxiety scores are measured in two groups of control and test.
Timepoint
Before and after the intervention
Method of measurement
Yale Modified Children Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After admission to the operating room, children in the intervention group while in the waiting room (half an hour before surgery) in addition to receiving routine and standard care with the help of parents and researchers for 15 minutes, with the simulated game software It is from the operating room environment and in addition to entertaining the child is effective in training and familiarity with the operating room. This researcher-made Iranian game software is installed on one of the parents' mobile phones. Anxiety scores are measured immediately after admission to the operating room (before the intervention) and 5 minutes immediately before the child is transferred from the waiting room to the operating room (after the intervention).
Category
N/A
2
Description
Control group :The children in the control group receive routine and standard care after being admitted to the operating room, in the waiting room, and play with toys according to the routine, and do not receive games with software. Anxiety scores are measured immediately after admission to the operating room (before the intervention) and 5 minutes immediately before the child is transferred from the waiting room to the operating room (after the intervention).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Ahmad Ghadami
Street address
Hazarjerib Street
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 31476815
Email
ghadami@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7533
Email
ghadami@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7533
Email
ghadami@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Individual participant data collected for the primary outcome measures
When the data will become available and for how long
After publication for one year
To whom data/document is available
For all those who request information
Under which criteria data/document could be used
Any analysis on the data is allowed, but printing the article on the data is prohibited
From where data/document is obtainable
Corresponding author of article
What processes are involved for a request to access data/document
After requesting the data, the data will be sent by email to the responsible author after a maximum period of one week