The effect of coloring mandala on attention level of children with attention deficit / hyperactivity disorder
Design
This research was a quasi-experimental before - after with the control group study, that was performed as a randomized clinical trial.
Settings and conduct
This study was conducted in the Nezam-Mafi clinic and meetings were formed in one of the rooms in the clinic and each group were composed of five. There were asked to color and finish one pre-drawn Mandela design on a sheet every session.In this study, the control group did not receive any intervention and did not attend any non-pharmacological intervention until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with mixed attention deficit/hyperactivity disorder based on psychiatrist diagnosis, Children 12-7 years old who go to school. Children and their parents have the motivation to cooperate and participate in the study. Children who have been treated with Ritalin for at least 3 months. Exclusion criteria: Children have other psychiatric disorders. Participation in non-pharmacological treatments during treatment, use of anti-anxiety and sedative drugs.
Intervention groups
Intervention group: Mandala Coloring Program was performed for 10 sessions (once a week) for the intervention group. Each session lasted 40-60 minutes. The Mandala method is every piece of artwork that is designed in a limited form (usually a circle). The Mandala designs are symbolic designs for generalization or integrity. The Mandala designs were selected from Mandada coloring books and were presented on A4 sheets.
Control group: No intervention was performed in the control group and they did not participate in any other non-pharmacological treatments at the same time.
Main outcome variables
Attention level
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20190729044370N1
Registration date:2020-06-30, 1399/04/10
Registration timing:retrospective
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
zahra Borzabadi Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3485 0603
Email address
farahani.z201625@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
The effect of art therapy (Mandala painting) on attention level of children with attention deficit/hyperactivity disorder (ADHD)
Public title
The effect of mandala on Attention level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with combined attention deficit / hyperactivity disorder based on a psychiatrist's diagnosis
Children 12-7 years old who go to school
Children and their parents have an incentive to collaborate and participate in the study.
Children who have been treated with Ritalin for at least 3 months
Exclusion criteria:
Children with other psychiatric disorders.
participating in other non-pharmacological treatments during the study.
taking Anxiolytic and sedative drugs.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sample from 90 children who had the criteria to enter were selected by simple random sampling. Each of these children had equal chance to be selected in intervention and control groups. Each child’s name was on a separate card and placed in a box. Then we mixed the cards and drew out the first 21 cards as the intervention group and the second 21 cards as the control group.
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 The University of Social Welfare and Rehabilitation Sciences
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Level of attention in Jordan's attention deficit disorder
Timepoint
Measurement of attention level before intervention and 2 weeks after intervention
Method of measurement
Jordan's attention deficit disorder
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mandala Coloring sessions were set up once a week for 40-60 minutes for the intervention group. In this method, the mandala patterns were chosen from Mandela coloring books. In order to hold meetings and to maintain attention and concentration, the intervention samples were divided into 4 groups, each comprising 5-6 members. In the first session, the children were introduced to the researcher and other children and the goal of holding classes. then they colored and finished one pre-drawn Mandela design on an A4 sheet with provided colored pencils every session. In the Mandala coloring session children were totally free in color selection and the mode of coloring. The Mandalay designs presented at each session were different from the sessions before, and all the people in the groups painted a similar design every session. The patterns presented in each session were different. This method was in use until 10 sessions.
Category
Treatment - Devices
2
Description
The control group: it was selected as a comparison group and received no intervention and there was no other non-pharmacological intervention until the end of the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nizam Mafia Rehabilitation Clinic
Full name of responsible person
Mahdi Khanke
Street address
Next to the Nizam Mafia S Mosque, after Jannatabad Road, Ayatollah Kashani Blvd
City
Tehran
Province
Tehran
Postal code
1474673776
Phone
+98 21 4403 8755
Fax
+98 21 4403 8703
Email
nezammafi@uswr.ac.ir
Web page address
http://nezammafi.uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Reza Khodaei Ardakani
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
Kh.ardakani@uswr.ac.ir
Web page address
http://en.uswr.ac.ir
Grant name
Vice-Chancellor for Research and Technology
Grant code / Reference number
254
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Borzabadi Farahani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ave Nilofar6,Pardis1 Town, Arak
City
Arak
Province
Markazi
Postal code
3817648731
Phone
+98 86 3485 0603
Email
farahani.z201625@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Borzabadi Farahani
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nilofar6 Ave, Pardis1 Town, Arak
City
Arak
Province
Markazi
Postal code
3817648731
Phone
+98 86 3485 0603
Email
farahani.z201625@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Borzabadi Farahani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nilofar6 Ave, Pardis1 Town, Arak
City
Arak
Province
Markazi
Postal code
3817648731
Phone
+98 86 3485 0603
Email
Farahani.z201625@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
Part of the data, such as information about the level of attention, can be shared
When the data will become available and for how long
Start access period 3 months after publishing results
To whom data/document is available
The data will be available to all researchers and individuals working in academic centers and institutes.
Under which criteria data/document could be used
The data will be available to all researchers and individuals working in academic centers and institutes.