Determining the effect of drawing peers on the happiness of children with cancer at school ages
Design
Two arm parallel group trial with outcome assessment and Blocked Randomization
Settings and conduct
The study is don at the medical center hospital(blood ward and clinic) on school age children suffering of cancer.that performed free painting session in response to the drawing of healthy schoolmates at 5 session.
Participants/Inclusion and exclusion criteria
Interior Criteria: A child with Age range 7 to 11 years.
Be able to understand and answer the questions.
Not having a disability to draw a painting
Exterior Criteria: Children who do not paint more than twice and Baby's death
Intervention groups
For children in both control and intervention groups ,the Happiness Questionnaire is completed before and after the intervention(painting) and then the painting project(5 painting steps with approx one week interval) is don for the intervention group.At each session ,the first one was shown by the researcher to the drawing of healthy counterparts who have been given a free subject for sick children and she asks them to draw their painting with a favorite theme now.In the end ,the questionnaires will be completed for both groups.
Main outcome variables
The happiness of children with cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150928024239N4
Registration date:2018-05-28, 1397/03/07
Registration timing:registered_while_recruiting
Last update:2018-05-28, 1397/03/07
Update count:0
Registration date
2018-05-28, 1397/03/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66927171
Email address
zareiikh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of painting by peers on happiness in school-aged children with cancer
Public title
The effect of painting by peers on happiness in school-aged children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age period :7 - 11 year
Ability for painting
Be able to understand and answer the questions in Persian language
Exclusion criteria:
child death
Children who do not paint more than two sessions
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization have done according balance blocked randomization with four groups in each block.
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 Tehran University of Medical Sciences
Street address
Tehran,tohid square, school of nursing&midwifery
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Approval date
2017-09-21, 1396/06/30
Ethics committee reference number
IR.TUMS.FMN.REC.1396,3441
Health conditions studied
1
Description of health condition studied
Children's Happiness
ICD-10 code
c80.1
ICD-10 code description
Malignant (primary) neoplasm, unspecified
Primary outcomes
1
Description
Happiness score in the Children Happiness Scale-Roger Morgan
Timepoint
The Children Happiness Scale-Roger Morgan Questionnaire gets complete in the intervention and control groups before and after the intervention by children.
Method of measurement
The Children Happiness Scale-Roger Morgan Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is the intervention group including hospitalized children who are seven to eleven years old admitted with cancer in the Children's Medical Center Hospital. They divided based on inclusion and exclusion criteria into intervention and control groups. Intervention consists of five free subject painting sessions on the intervention group. Initially, they are shown painting that have drawn by healthy peers for children with cancer. Then the researcher requests them to draw a painting counterpart in response. Painting sessions are held five times with one-week interval approx, so it takes about 40 days to complete an intervention for each trial. Paper, crayons, pencil and color marker are provided. In the end, the paintings are collected by the researcher. The second group, the control group, is the same as the intervention group, but no intervention by the researcher is performed on them. They take routine care. Happiness assessments were done two times through the Happiness Questionnaire by both of the control and intervention groups, before the first intervention and again after the last intervention.
Category
Behavior
2
Description
The control group is the same as the intervention group, but they do not received any intervention by the researcher. They just received routine intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Somayeh Palvan
Street address
Tehran, Keshavarz Boulvard, Doctor Gharib Avenue, next to Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
021-1419733151
Phone
+98 21 6692 0981
Fax
+98 21 6693 0024
Email
chmc@tums.ac.ir
Web page address
http://chmc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Modares
Street address
Tehran,Tohid square,School of Nursing &Midwifery
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
resdeputy@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Grant name
Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Zarei
Position
Instructor, Faculty's Member of Nursing and Midwifery, Tehran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran, Tohid Square, School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Phone
+98 66927171
Fax
+98 21 6690 4252
Email
zareiikh@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Zarei
Position
Instructor, Member of Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran, Tohid Squre, School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Phone
+98 66927171
Fax
Email
zareiikh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Palvan
Position
Student of Masters Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Lahijan,Golestan square, Golestan 21 Ave.kalantari building
City
Lahijan
Province
Guilan
Postal code
۴۴۱۴۹۳۷۱۶۷
Phone
+98 13 4242 3624
Fax
+98 13 4229 3827
Email
zareiikh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Only a portion of the data which is the main outcome information could be shared.
When the data will become available and for how long
A clinical study will report six months after the publication of the results.
To whom data/document is available
Professors, and students who have permission from me and my professors.
به چه منظور و تحت چه شرایطی داده/مستند قابل استفاده است
.
Under which criteria data/document could be used
Not applicable to the public.
From where data/document is obtainable
zareiikh@tums.ac.ir
s.palvan@gmail.com
And the Library of the Faculty of Medicine, which is the basis of the thesis.
What processes are involved for a request to access data/document
No documented documents except the thesis recorded in the University Library of the Faculty of Medical Sciences are currently available.
Comments
Only those written in the thesis are available, in which the thesis is also available at the Faculty Library.