.The Effect of Cognitive-Behavioral Therapy on Social Adjustment and Self-esteem of Thalassemic Patients in Pasteur Hospital in Bam
Design
The study included two groups of control and intervention which were selected from among patients referring to the pastoral hospital of the age group of 15 years old.
Settings and conduct
Interventional study - Pasteur Bam Hospital
Participants/Inclusion and exclusion criteria
Patients with an age group over 15 years of age have a minimum level of reading and writing literacy, or if the psychological disorder is confirmed and does not fill the questionnaire for any reason or is incompletely completed.
Intervention groups
92 persons were selected by census method and then randomly assigned randomly to the intervention group of the control group randomly (46 people per group). the researcher divided the intervention group into two groups of 23, and the intervention group held 8 sessions of 90 minutes training. After the completion of group training sessions, one month later, posttest was performed for both intervention and control groups (14). And then, based on the data obtained, the results were examined. There was no intervention for the control group
Main outcome variables
social adjustment and self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180704040333N1
Registration date:2018-09-29, 1397/07/07
Registration timing:retrospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Mahnaz Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4434 4609
Email address
m.hasani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-07-15, 1397/04/24
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2018-07-15, 1397/04/24
Trial completion date
2018-08-10, 1397/05/19
Scientific title
Comparison of the Effectiveness of Cognitive-Behavioral Therapy on Social Adjustment and Self-esteem in Thalassemic Patients
Public title
The Effect of Cognitive-Behavioral Therapy on Social Adjustment and Self-esteem in Thalassemic Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Group over 15 years old
Have at least reading and writing skills
Exclusion criteria:
Having mental disorder confirmed
Failure to complete the questionnaire for any reason or defect in completing the questionnaire
Having more than two absences
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
106
Actual sample size reached:
92
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention group is randomly selected from among 106 participants, and the control group remains unaware of the study of what study and where it is done.
Placebo
Not used
Assignment
Parallel
Other design features
Since the number of patients in the age group over 15 years old who referred to thalassemia clinic was 106, all patients were enrolled by census method and then divided into two intervention and control groups using simple random sampling. The samples were divided into two groups according to the gender variable (± 2). In other words, the first sample was randomly assigned to one of the two intervention groups or control group using the lottery and the subsequent samples were assigned to each group according to the matching variables and the random conditions. .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Four Way Somayeh (Tahmasebabad), Beginning of Jihad Boulevard, Beginning of Ibn Sina St.
City
Kerman
Province
Kerman
Postal code
7619813160
Approval date
2018-03-30, 1397/01/10
Ethics committee reference number
IR.KMU.REC.1397.057
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
1- Social Adjustment:It means a person's compromise with the social environment that this adaptation can be created by adapting itself to the environment or changing the environment to meet the needs and achieve desirable
Timepoint
Before the intervention and 30 days later
Method of measurement
Bell Social Reconciliation Questionnaire and Rosenberg Self-Esteem Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The cognitive-behavioral group therapy group was evaluated in addition to receiving routine care with Bell's social adjustment questionnaire and Rosenberg self-esteem questionnaire. Then, 8 sessions of 90 minutes and one week of cognitive-behavioral therapy were performed for them. One Month after the completion of group training sessions are evaluated using the mentioned questionnaires.
Category
Behavior
2
Description
Control group: Control group: The group only received routine care. Before the intervention group begins cognitive-behavioral therapy, a social and self-esteem Rosenberg questionnaire is used to evaluate and, during the course of this intervention, no intervention for this non- There is no routine care and after a month, the questionnaires are evaluated by this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasteur Hospital
Full name of responsible person
Mahnaz Hasani
Street address
Pasteur Hospital, Shahid Rajaee Blvd، Town Bam
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 35 3525 5011
Fax
+98 35 3525 5011
Email
m.hasanii6660@gmail.com
Web page address
http://za.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
At the Beginning of The Axis of Haft Hagh Alavi University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
m.hasanii6660@gmail.com
Web page address
http://za.kmu.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahnaz Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of the Axis Ofhaft Bagh Alavi, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.hasanii6660@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahnaz Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of The Axis OfhaftBagh Alavi, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.hasanii6660@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahnaz Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beginning of The Axis of Haft Bagh Alavi, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
m.hasanii6660@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data can be shared after unidentifiable individuals
When the data will become available and for how long
Potential data can be shared after unidentifiable individuals
To whom data/document is available
Start the month access period after printing the results
Under which criteria data/document could be used
Researchers working in academia and academia
From where data/document is obtainable
The data is sent through an official request and by e-mail
What processes are involved for a request to access data/document
The data is sent through an official request and by e-mail
Comments
The data is sent through an official request and by e-mail