The aim of this study is determining effect of video games on preoperative anxiety among 3-6 years old children. This study is a random clinical trial containing both intervention group and control group that is carried out in pediatrics hospitals. Children are located in either control group or intervention group at random. For the intervention group, anxiety test is performed before entering the waiting room by means of m-Yale PAS tool; and then the children play the video game for twenty minutes. After that, children are injected with 0.5 mg/kg Midazolam and transferred to the operation bed. In the control group, children wait twenty minutes in the waiting room instead of playing the video game. The second anxiety test is carried out after transferring to the operation bed. In order to perform a blind study, trained nurses who measure anxiety are not aware whether intervention is carried out or not. Each group contains 45 children without any background in surgery or hospitalization. Children should not have any chronic degenerative disease and their parents should not be a hospital member. In the intervention group, children should be familiar with video game and play more than fifteen minutes. In this research, primary outcome measure is preoperative anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631114N1
Registration date:2017-04-30, 1396/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-30, 1396/02/10
Registrant information
Name
Elham Rostami
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
e.rostami.77@gmail.com
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery-Nursing Care Research Center
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of video games on preoperative anxiety in children aged 3-6 years old undergoing elective surgery
Public title
effect of video games on preoperative anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Entrance criteria:
Neither chronic degenerative disease nor mental disorders; should not be observed based on both parents’ statements and the patient background file; None of parents should not be a hospital personnel; The child should not have been hospitalized before this study.
Exit criteria:
The child don’t play until fifteenth minutes of time; The child is not familiar with video games.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences, School of Nursing and Midwifery
Street address
Rashid Yasemi St. Valiasr St. Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
IR.IUMS.REC 1395.9311687005
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
Acute stre
ICD-10 code description
Acute stress reactionF43.0
2
Description of health condition studied
anxiety
ICD-10 code
Anxiety di
ICD-10 code description
Anxiety disorder, unspecified F41.9
Primary outcomes
1
Description
Preoperative Anxiety
Timepoint
Pre intervention-Post intervention
Method of measurement
modified yale preoperative anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
In the control group‚ children will stay in holding area for 15-20 minutes.
Category
N/A
2
Description
In this research, the intervention is video game.
In the intervention group‚ children will play with video game verified by pediatric psychiatrist‚ in holding area. Duration of the intervention is 15-20 minutes.