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The Effect of Applying Life Skills on Quality of Life in Major Thalassemic Adolescents

Protocol summary

Study aim
Determining the Effect of Dexterity Life on Quality of Life in Adolescents with Thalassemia Major
Design
The research units will be selected through easy and available sampling from these adolescents. Subjects will then be divided into two groups of intervention (42) and the control group (42). Detection in each of the two groups is randomly based on The lottery is then followed by both groups of pre-test questionnaires. This study is a clinical trial with a control group, community based and pragmatic, non-blind.
Settings and conduct
The training intervention will be conducted by the researcher in six sessions for 2 sessions. The training material will be performed in each two-skill training session and reviewing the previous skills. The last session of the review will be all the material being told. At each meeting ... people are present. Meetings are held at the conference hall of the Baghaee Hospital 2.
Participants/Inclusion and exclusion criteria
The teenager tends to attend educational sessions. The person has not previously participated in life skills training courses. Not having simultaneous chronic illnesses and other treatments (known).
Intervention groups
In this study, the samples were divided into intervention and control groups. The control group receives ten life skills, but the control group does not receive intervention. At the end, the effectiveness of applying these skills and its impact on the quality of life of the control group is measured and compared with the control group
Main outcome variables
Physical dimension of quality of life, physical dimension, psychological dimension, dimension of school environment, self-perception, social acceptance and relationship with peers, financial resources, autonomy, creativity and excitement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181202041825N1
Registration date: 2019-03-09, 1397/12/18
Registration timing: retrospective

Last update: 2019-03-09, 1397/12/18
Update count: 0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Hadis Zamanifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4322 4819
Email address
zamanifar.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2018-11-13, 1397/08/22
Actual recruitment start date
2018-11-06, 1397/08/15
Actual recruitment end date
2018-11-13, 1397/08/22
Trial completion date
empty
Scientific title
The Effect of Applying Life Skills on Quality of Life in Major Thalassemic Adolescents
Public title
The Effect of Applying Life Skills on Quality of Life in Thalassemic Adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study. Not known to have any other illness (known) The person has not participated in life skills training courses before
Exclusion criteria:
Do not attend life skills classes.
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to individuals is randomized and random blocked blocks with block size 4 (using the table for random permutations)by statisticain.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the University of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 7, West Golestan Ave., Golestan Blvd., AhvazTown
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.AJUMS.REC.1397.572

Health conditions studied

1

Description of health condition studied
Major Talasemi
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia

Primary outcomes

1

Description
Quality of Life Score in Kidascrine's Questionnaire 52
Timepoint
At the beginning of the study and 3 months after it began
Method of measurement
Quality of life questionnaire for adolescents in Kidascrine 52

Secondary outcomes

1

Description
quality of life
Timepoint
Before starting the study. 2months after teaching life skills, quality of life is measured
Method of measurement
According to the Quality of life questionnaire for adolescents in Kidascrine 52

Intervention groups

1

Description
Intervention group: Pretest is taken. Next, intervention is the teaching of ten life skills (skills provided by the World Health Organization) in the form of classroom classes, questions and answers, the use of visual audiovisual equipment, instructional manuals, etc. 2 months later, the post-test is taken.
Category
Behavior

2

Description
Control group: This group is taken out of the pre-test. They will not receive the training. 2 months later, the post-test is taken
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghaee2 Hospital
Full name of responsible person
Hooshang Alijani Renani
Street address
Baghaee2 Hospital.,Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
alijani-h@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alijanirenani Hoshang
Street address
Golestan Highway, Ahwaz University of Medical Sciences, Nursing Midwifery Faculty
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3373 8331
Email
alijani-h@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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

2

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvī
Street address
No. 7, West Goolestan Ave., GolestanBlvd., AhvazTown
City
Ahvaz
Province
Khouzestan
Postal code
1234567890
Phone
+98 61 3373 8331
Email
hadiszamanifar69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Alijanirenani Hoshang
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 7, West Maryam Ave., Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
alijani-h@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alijanirenani hoshang
Position
University professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ahvaz, Loban Golestan, Jundishapur University of Ahwaz, Nursing Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
1234567890
Phone
+98 61 3373 8395
Email
alijani-h@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zamanifar Hadis
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahwaz Ahwaz Jundishapur University. Nursing Midwifery Faculty
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
zamanifar.h@ajums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
En Information on the primary outcome and the secondary outcome is shared.
When the data will become available and for how long
Start the access period, 6 months after printing the results
To whom data/document is available
En Data is only available to researchers working in universities
Under which criteria data/document could be used
It is applicable to life skills and adolescents of thalassemia
From where data/document is obtainable
t is available to assess the knowledge and performance of families.
What processes are involved for a request to access data/document
The application must first be sent to the Ahwaz University of Medical Sciences. After being examined by the Vice-Chancellor, the application will be sent to the Nursing Midwifery Faculty, and will be sent to the Nursing Midwifery Library after being submitted to the library.
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