Determination of the effect of mandala painting on the anxiety of children aged 6 to 14 years with cancer
Design
Clinical trials with control group, Selection of samples based on purpose, Parallel group, no blind spot, Randomized
Settings and conduct
Interventions will be held in the oncology section of the Children's Medical Center Hospital affiliated to Tehran University of Medical Sciences. sampling will take place every other week. first week the intervention group And next week the control group will be selected.
Participants/Inclusion and exclusion criteria
inclusion criteria: interested to participate in the study, aged in 6 and 14, has one type of cancer, don't be in end stage of cancer, based on inventory doesn't have severe anxiety and don't use any drug for anxiety.
exclusion criteria: discharge or transfer to another hospital, unwillingness to continue to participate in research, absence more than one session
Intervention groups
Hold mandala coloring sessions for 6 sessions And everyday of the week for an hour in the intervention group and do not intervention for control group
Main outcome variables
anxiety of children with cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041618N1
Registration date:2019-02-28, 1397/12/09
Registration timing:registered_while_recruiting
Last update:2019-02-28, 1397/12/09
Update count:0
Registration date
2019-02-28, 1397/12/09
Registrant information
Name
Mona Moharamkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5572 4326
Email address
monamoharamkhani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-16, 1397/11/27
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing of the Effect of Mandala Painting on Anxiety of 6 - 14 Year Old Children with Cancer
Public title
Effects of Mandala Painting on Anxiety of Children with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
don't have severe anxiety
Interested in Participating in Research
Aged in 6 - 14 Year Old
Not in End Stage of Cancer
Don't use any Drug for Anxiety
Exclusion criteria:
Discharge or Transfer to other center
Don't be interested to participating in Research
Absence more than one session
Age
From 6 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Target-based sampling based on the criteria for entering the study Then the samples were assigned to two groups of intervention and control By random method and using random numbers table
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 committe of shahid beheshti university of medical sciences
Street address
No. 77, Eji Ave., Aboozar St., Qazvin Sq
City
tehran
Province
Tehran
Postal code
1366648918
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.154
Health conditions studied
1
Description of health condition studied
Anxiety of children with cancer
ICD-10 code
C00-D48
ICD-10 code description
Neoplasm
Primary outcomes
1
Description
Anxiety of Children with Cancer
Timepoint
Anxiety Measurement Before and After Intervention And one month after the last intervention session
Method of measurement
The spilberger's State-Trait Anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: held up mandala coloring sessions for six sessions and every day of the week for one hour
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's medical center hospital
Full name of responsible person
miss tahmineh naji
Street address
Doctor qarib st
City
tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0068
Email
cmc.tums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
doctor Mahrokh Dolatian
Street address
vali-e-asr st
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
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
monamoharamkhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 77., Eji Ave., Aboozar St., Qazvin Sq
City
tehran
Province
Tehran
Postal code
1366648918
Phone
+98 21 5572 4326
Email
monamoharamkhani99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
monamoharamkhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Aboozar
City
tehran
Province
Tehran
Postal code
1366648918
Phone
+98 21 5572 4326
Email
monamoharamkhani99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mona moharamkhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 77., Eji Ave., Aboozar St., Qazvin Sq
City
tehran
Province
Tehran
Postal code
1366648918
Phone
+98 21 5572 4326
Email
monamoharamkhani99@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
at the end of the study, information on the main outcome can be shared.
When the data will become available and for how long
start the access period 6 months after printing results
To whom data/document is available
all people
Under which criteria data/document could be used
for use in similar studies with source mention and use of intervention in the hospital
From where data/document is obtainable
access to the published articles of this study and send a email to the main executor's ,to the address: monamoharamkhani@sbmu.ac.ir
What processes are involved for a request to access data/document