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IRCT20150715023216N10 IRCT 2021-10-19 Esfahan University of Medical Sciences The effect of using game application on anxiety before surgery in children The effect of using game application on anxiety before surgery in children aged 5-11 years 2021-10-25 anticipated 70 Complete https://irct.ir/trial/59355 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 description: The statistical analyst is unaware of which group each sample belongs to. N/A Anxiety. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: Individual participant data collected for the primary outcome measures When: After publication for one year To whom: For all those who request information Conditions: Any analysis on the data is allowed, but printing the article on the data is prohibited Where to obtain: Corresponding author of article How to obtain: After requesting the data, the data will be sent by email to the responsible author after a maximum period of one week Comments:
public Ahmad Ghadami
Isfahan University of Medical Sciences, Hezarjerib street
Isfahan Iran (Islamic Republic of) 8174673461 0098 31476815 ghadami@mui.ac.ir Esfahan University of Medical Sciences scientific Ahmad Ghadami
Isfahan University of Medical Sciences, Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7533 ghadami@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 5 years 11 years Both The child's unwillingness to play with the software Severe pain before intervention Emergency surgery F06.4 Anxiety disorder due to known physiological condition N/A N/A 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). 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). 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. Esfahan University of Medical Sciences Approved 2021-07-24 Ethics Committee of the School of Nursing, Management and Rehabilitation - Isfahan University of Med Hezarjerib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)