Investigating the effect of digital painting on preoperative anxiety in children
Design
A randomized controlled clinical trial on 60 patients. The rand function of Excel software is used for randomization.
Settings and conduct
This study will be conducted in Bo Ali Hospital, Sari. Before surgery, all children will be present with their mother for 15 minutes in a room located within the operating room. During this time, the child in both groups will not receive any medicine. According to the allocation of each person's group, the intervention is carried out. The assessment of anxiety before and after the intervention will be done by another person who is not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 6 to 12 years
Exclusion criteria: No history of previous surgery
Intervention groups
The software under the Android "Coloring and Learn" made by "Orange Studios Games", which is downloaded from Cafe Bazaar and installed on the tablets, and the program will be given to the child while it is running on the tablet, and from the 30 ready images in this software First, the child will be taught how to choose and color by the researcher, and then the child will be allowed to choose as many pictures as he wants and color as he wants. The duration of coloring will be 15 minutes.
No intervention is performed in the control group.
Main outcome variables
Child anxiety, Mother Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110430006342N14
Registration date:2023-04-07, 1402/01/18
Registration timing:prospective
Last update:2023-04-07, 1402/01/18
Update count:0
Registration date
2023-04-07, 1402/01/18
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of digital painting on 6-12 years old children’s preoperative anxiety
Public title
Investigating the effect of digital painting on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
6 to 12 years old
Ability to verbally communicate
Ability to painting
Informed consent of parents and children to participate in the study
Exclusion criteria:
Presence of acute and chronic pain in the child
mental retardation
History of previous surgery
cognitive and mental illness of children, as confirmed by parents
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples is done as a random block of four prepared using Excel software. A represents the test group and B represents the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluating nurse enters the child's room before and after the intervention and measures the child's anxiety level using the m-YPAS anxiety questionnaire. He is not aware of the type of intervention. The intervention and control groups are marked with the letters A and B so that the statistician does not know the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Semnan University of Medical Sciences
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1401.339
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Completing the Modified Yale Preoperative Anxiety Scale (m-YPAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the software under the Android operating system called "Coloring and Learn" made by "Orange Studios Games" which is downloaded from Cafe Bazaar and installed on the tablets and the program will be given to the child while it is running on the tablet and from 30 ready images in In this software, the first picture is selected by the researcher and the child is taught how to color, and then the child will be allowed to choose as many pictures as he wants and color as he wants. The duration of coloring will be 15 minutes.
Category
Other
2
Description
Control group: There is no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Sinai Hospital, Sari
Full name of responsible person
Mehrasa Mottaghi
Street address
Bo Ali Sinai Hospital, Sari
City
Sari
Province
Mazandaran
Postal code
-33556259
Phone
+98 935 982 5820
Email
mehrasa.mottaghi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohamadkhani
Street address
Deputy of research and technology, Central Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3105 2120
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road,
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Semnan University of Medical Sciences, Km 6 Damghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
aaghods@yahoo.com
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
Six months after the completion of sampling
To whom data/document is available
Officials of the research assistant and referees
Under which criteria data/document could be used
On request
From where data/document is obtainable
Ali Asghar Ghods
aaghods@yahoo.com
What processes are involved for a request to access data/document
The request is reviewed and decided by the study team