Determination and comparison of the effects of both narrative and painting techniques on improving self-concept in children aged 16-9 years with thalassemia major
Design
Clinical trial has two groups of intervention, parallel, uncorrected, simple random
Settings and conduct
Clinical Examination in Blood and Thalassemia Centers in Educational and Therapeutic Centers
Participants/Inclusion and exclusion criteria
Absence of acute or chronic disease other than thalassemia major
Have reading and writing skills
The desire to participate in the study
Lack of experiencing stressful situations, such as the death of parents
Child's death during intercourse
Having absences in two consecutive sessions
Intervention groups
Children with major thalassemia
Main outcome variables
Whitening and painting have been effective in improving the self-concept of children with thalassemia major
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101013004922N3
Registration date:2018-07-16, 1397/04/25
Registration timing:retrospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Mohammad Sahebzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2281 1045
Email address
m_szamani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
empty
Scientific title
The effect of two methods of narration and painting on self-concept in children with thalassemia major
Public title
The effect of two methods of narration and painting on self-concept in children with thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children who do not have any criterion for diagnosis for a psychological disorder such as depression, psychosis, autism, or personality
Absence of acute or chronic disease other than thalassemia major
Children who have literacy to read and write.
Children who have not experienced stressful conditions such as parenting deaths in the past.
Children who are willing to participate in the study
Exclusion criteria:
Children who die during treatment.
Children who are not willing to continue studying.
Having absences in two consecutive sessions
The occurrence of any crisis or tension affecting the child's self-image during the study
Age
From 9 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
35
Randomization (investigator's opinion)
N/A
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
The Ethics Committee of Islamic Azad University, Tehran Medical Sciences Branch
Street address
Knowledge Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.IAU.TMU.REC.1396.184
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Improve self-concept
Timepoint
Before and after the intervention
Method of measurement
Peyz-Harris Self-Concept Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Narrative Writing - In this study, six sessions of 1 hour of narration were presented to the narrative group from January 1, 1396 to June 1, 1397. The investigator (Fariba Jamalpur) is a narrative of therapy. During the first meeting, the purpose of the narrative was to predict the benefits of this method. Second session; describe the problem of the third session; naming the fourth session problem; the impact of the problem in the fifth session life; the problem of the breakdown of the problem; and the sixth session; the retelling of the narrative of life was presented.
Category
Behavior
2
Description
Intervention Group 2: Painting - In this study, 6 sessions of 30 minutes of painting were presented to the painting group from January 1, 1396 to June 1, 1397. The investigator (Fariba Jamalpur) has an official degree and the materials of the painting sessions are approved by psychologists and with consultation. They were asked during the meetings to paint what they wanted and wanted, and finally explain their drawings, and at the end the researcher talked about the issues and gave feedback to the samples
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational-therapeutic hospitals: Ali Asghar (AS), Children's Medical Center and Bahrami Medical Ce
Full name of responsible person
Fariba Jamalpoor
Street address
Keshavarz Blvd.Nicket Hospital, Children's Medical Center Hospital
City
Tehran
Province
Tehran
Postal code
1345764815
Phone
+98 21 6147 2911
Email
m_szamni@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Sahebzamani
Street address
Street Sattari North, University student toward Hesarak, Central building of Islamic Azad University, 6th grade
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 6147 2611
Email
m_szamzni@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Sahebazamani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
SStreet Sattari North, University student toward Hesarak, Central building of Islamic Azad University, 6th grade
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 61472911
Email
m_szamzni@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Sahebzamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Street Sattari North, University student toward Hesarak, Central building of Islamic Azad University, 6th grade
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4167 2911
Email
m_szamani@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Sahebazamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Street Sattari North, University student toward Hesarak, Central building of Islamic Azad University, 6th grade
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4167 2911
Email
m_szamani@iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available