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Comparing the Effectiveness of Mandala Coloring and Playing with Lego on Children’s Pre-operative Anxiety

Protocol summary

Study aim
Comparison of the effect of mandala coloring and playing with Lego on children’s pre-operative anxiety
Design
This study is a simple randomized clinical trial.The study samples are 105 pre-operative children admitted to Mofid Hospital and Children's Medical Center.The allocation of the children in three intervention and control groups is based on the arrival day,so that in the columns, "Saturday, Sunday", "Monday, Tuesday" and " Wednesday, Thursday" is placed.The mandala group is classified in the "Saturday Sunday", the Lego group is classified as "Monday Tuesday" and the control group is classified in the "Wednesday Thursday" column.This process continues until the sampling is completed.
Settings and conduct
First,in all three groups,the child's anxiety is measured before entering the operating room with Spielberger's anxiety questionnaire.If the child's anxiety is moderate to severe,in the mandala group,a mandala design is colored for 15-20 minutes and in the Lego group,building different shapes with Lego bricks is done.Then, in the two intervention groups, the child's anxiety is checked immediately after the intervention, and in the control group,only the child's anxiety is checked at the same intervals.
Participants/Inclusion and exclusion criteria
Inclusion:‎Not suffering from separation anxiety,no surgery history,Exclusion:‎existence of mental illness,need for emergency surgery
Intervention groups
In the mandala coloring group, five different mandala painting designs and a 12 colored pencils pack are provided to the child.He chooses from the designs and paints it in 15-20 minutes.In the Lego group,a box containing different parts is provided to the child and he is asked to make different shapes.In both groups,anxiety will be checked before and immediately after the intervention.In the control group,only the anxiety is checked before the operation.
Main outcome variables
anxiety level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220203053920N1
Registration date: 2022-07-20, 1401/04/29
Registration timing: prospective

Last update: 2022-07-20, 1401/04/29
Update count: 0
Registration date
2022-07-20, 1401/04/29
Registrant information
Name
Reihane Moghimian Shahrbabaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9438
Email address
moghimianreihane1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Mandala Coloring and Playing with Lego on Children’s Pre-operative Anxiety
Public title
Effectiveness of Mandala Coloring and Playing with Lego on Children’s Pre-operative Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and written consent Age 6 to 18 years and both sexes Having the ability to communicate verbally The ability to paint, draw and play with Lego toys The child does not have a cognitive disorder, language problems, hearing disorders, neurological conditions based on the file documents Not suffering from separation anxiety and known phobia Absence of severe pain before the intervention with visual analogue scale (VAS) No history of surgery
Exclusion criteria:
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Intersection of Hashemi Rafsanjani Blvd and Valiasr Street, Zahra Hostel
City
Tehran
Province
Tehran
Postal code
1481999586
Approval date
2022-01-29, 1400/11/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.975

Health conditions studied

1

Description of health condition studied
mandala coloring ‎
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Play with Lego
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Spielberger State–Trait Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the mandala coloring group, after measuring the child's anxiety, five ‎different designs of mandala painting are provided to the child separately on ‎A4 paper and a pack of 12 colored pencils. He/She chooses from the designs ‎and paints it in 15-20 minutes, then the anxiety questionnaire is completed ‎again by the child.‎
Category
N/A

2

Description
Intervention group: In the Lego group, after measuring the child's anxiety, a box containing ‎different parts is provided to the child and the child is asked to make different ‎shapes from the manual or his creativity, then the anxiety questionnaire is ‎completed again by the child.‎
Category
N/A

3

Description
Control group: In the control group, there is no intervention and the child's anxiety is checked ‎only at the same time intervals in the two groups of mandala coloring and ‎Lego.‎
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid hospital
Full name of responsible person
Reihane Moghimian Shahrbabaki
Street address
Alzahra dormitory, Intersection of Hashemi Rafsanjani Blvd and Valiasr Street
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
moghimianreihane1@gmail.com

2

Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Reihane Moghimian Shahrbabaki
Street address
Alzahra dormitory, Intersection of Hashemi Rafsanjani Blvd and Valiasr Street
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
moghimianreihane1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reihane Moghimian Shahrbabaki
Street address
Alzahra dormitory, Intersection of Hashemi Rafsanjani Blvd and Valiasr Street
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
moghimianreihane1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reihane Moghimian Shahrbabaki
Position
Master student of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alzahra dormitory, Intersection of Hashemi Rafsanjani Blvd and Valiasr Street
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 34 3311 1804
Email
moghimianreihane1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ali omidi
Position
master of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 4, Moghadam Deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reihane Moghimian Sharbabaki
Position
Master student of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alzahra dormitory, Intersection of Hashemi Rafsanjani Blvd and Valiasr Street
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
moghimianreihane1@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unrecognizable individuals in the article format.
When the data will become available and for how long
The access period starts from 2023
To whom data/document is available
It will be available for everyone
Under which criteria data/document could be used
Researchers are licensed by the research committee
From where data/document is obtainable
After the publication of the article, visit the journal's website for more information write to moghimianreihane1@gmail.com
What processes are involved for a request to access data/document
Researchers can receive the necessary response after two weeks by sending an e-mail to the person in charge.
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