Determining the effect of mandala coloring on the anxiety of children with cystic fibrosis
Design
This study is a simple randomized clinical trial.The study samples are 130 children with cystic fibrosis admitted to Mofid.Allocation of samples to intervention and control groups will be random and using a table of random numbers.
Settings and conduct
In this research with the context of children's anxiety,first, in both groups,the anxiety of children hospitalized in the pulmonary department of Mofid Hospital is measured with Spielberger's state-trait anxiety questionnaire before the intervention.If the child's anxiety was moderate to severe, in the mandala coloring group,for six consecutive days in the evening for 30 minutes,a mandala design is colored with colored pencilsthen,the child's anxiety is checked in the evening of the sixth day of the intervention and in the control group,only the level of children's anxiety will be examined before routine care and six days after that.
Participants/Inclusion and exclusion criteria
Inclusion:
1.The ability to communicate
2.The ability to paint
3.The child does not have a cognitive and hearing disorders,neurological conditions based on the documents
Exclusion:
1.Physical and mental inability to draw or paint
2.The existence of cognitive disability and mental illness of the child
Intervention groups
In the mandala coloring group,for six consecutive days in the evenings,five different designs of mandala painting and a pack of 12 colored pencils are provided to the child.He/She is asked to choose one of the designs and paints it in 30 minutes and in the evening of the sixth day of the intervention,the level of anxiety will be checked again.In the control group,there will be no intervention and only the level of children's anxiety will be examined before routine care and six days after that.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052665N2
Registration date:2022-11-20, 1401/08/29
Registration timing:prospective
Last update:2022-11-20, 1401/08/29
Update count:0
Registration date
2022-11-20, 1401/08/29
Registrant information
Name
Ali Omidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 0000 0000
Email address
aliomidi978@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mandala coloring on anxiety of children with cystic fibrosis
Public title
The effect of mandala coloring on anxiety of children with cystic fibrosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and written consent
Age 6 to 18 years
Definitive diagnosis of cystic fibrosis
Having the ability to communicate verbally
The ability to paint
The child does not have a cognitive disorder, language problems, hearing disorders, neurological conditions based on the file documents
Exclusion criteria:
Physical and mental inability to draw or paint
The existence of cognitive disability and mental illness of the child
Leaving the research community (change of ward, death, etc.)
Non-cooperation to continue the research
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:
130
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
Research Institute of Children Health - Shahid Beheshti University of Medical Science
Street address
Shariati Street, Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
8313774691
Approval date
2022-10-12, 1401/07/20
Ethics committee reference number
IR.SBMU.RICH.REC.1401.026
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
before intervention and in the evening of the sixth day of 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, for six consecutive days in the evenings, five different designs of mandala painting are provided to the child individually on A4 paper and a pack of 12 colored pencils. And he chooses one of the designs as he likes and paints it in 30 minutes. In the evening of the sixth day of the intervention, the anxiety questionnaire is completed again by the child.
Category
N/A
2
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 mandala coloring group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Ali Omidi
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 2387 2416
Email
aliomidi978@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mofid Hospital Gastroenterology Research Center
Full name of responsible person
Ali Omidi
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 2387 2416
Email
aliomidi978@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mofid Hospital Gastroenterology Research Center
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
Ali Omidi
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 2387 2416
Email
aliomidi978@yahoo.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 science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 2387 2416
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
Ali Omidi
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 2387 2416
Email
aliomidi978@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
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 de-identifying 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
Researchers working in academic institutions or research centers
Under which criteria data/document could be used
Researchers are licensed by the research committee
From where data/document is obtainable
After publishing the article, visit the magazine site to get more information write to aliomidi978@yahoo.com
What processes are involved for a request to access data/document
Researchers can can receive the necessary response after two weeks by
sending an e-mail to the person in charge.