1. Home
  2. Approved trials
  3. » فارسی

The effect of applying emotional intelligence components on coping strategies in adolescents with β-thalassemia major

Protocol summary

Study aim
TO determine the effect of applying emotional intelligence components on coping strategies in adolescents with beta-thalassemia major
Design
A clinical trial, with control group and intervention, not randomized trial based on Even and odd days, 70 adolescents with beta-thalassemia major, not blinded
Settings and conduct
The research unit was thalasemia polyclinic of Mashhad (sarvar). It is a non-randomized trial based on even and odd days. Intervention group divided into groups of 3 to 5 people. There are 9 sessions of 90 minutes which were held twice a week.The sessions are in-person and virtual training in applying emotional intelligence components by the Bar-on method. Before, immediately and one month after the intervention, the tools will be filled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having the satisfaction to participate in the study, suffering from beta thalassemia major, age 12 to 18 years, minimum level of education at primary level, living with parents. Exclusion criteria: doing complementary therapies (acupuncture and yoga, etc.), passing similar courses on emotional intelligence, suffering from other known chronic physical and mental illness
Intervention groups
Control: receiving routine care. Intervention: in addition to routine care, they take part in applying emotional intelligence components classes
Main outcome variables
Coping strategy includes: problem-solving, cognitive evaluation, social support , emotional inhibition, Somatic inhibition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210521051356N1
Registration date: 2021-06-17, 1400/03/27
Registration timing: prospective

Last update: 2021-06-17, 1400/03/27
Update count: 0
Registration date
2021-06-17, 1400/03/27
Registrant information
Name
Bahareh Ahmadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3662 8916
Email address
ahmadianb981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying emotional intelligence components on coping strategies in adolescents with β-thalassemia major
Public title
the effect of applying emotional intelligence components on coping strategies
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the satisfaction to participate in the study Suffering from beta thalassemia major Age 12 to 18 years minimum level of education at primary level minimum level of education at primary level
Exclusion criteria:
Doing complementary therapies (acupuncture and yoga, etc.) Passing similar courses on emotional intelligence suffering from other known chronic physical and mental illness
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Four- way doctorate, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.017

Health conditions studied

1

Description of health condition studied
B-thalasemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia

Primary outcomes

1

Description
coping strategy
Timepoint
Before - immediately after- a month later
Method of measurement
Billings and Moos Coping Strategy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to receive routine care, they take part in applying emotional intelligence components classes for 9 sessions at 90 minutes twice a week using Bar-on method in groups of 3 to 5 people
Category
Behavior

2

Description
Control group: receive only routine care. After completing the task, the control group will be trained on how to apply emotional intelligence components.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sarvar thalassemia polyclinic
Full name of responsible person
Dr. Monir Ramezani
Street address
Sarvar polyclinic., 17 Shahrivar 8 St., 17 Shahrivar Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
ramezanimn@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora crossroads, Danshgah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
latifnejadr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Ahmadian
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora crossroads, Danshgah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
Ahmadianb981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Ahmadian
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora crossroads, Danshgah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
Ahmadianb981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Ahmadian
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora crossroads, Danshgah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
AhmadianB981@mums.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
When the data will become available and for how long
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
To whom data/document is available
The data are made available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
From where data/document is obtainable
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
What processes are involved for a request to access data/document
At the end of the work and after publishing the article, with permission from the Mashhad School of Nursing and Midwifery and related professors, information will be available in the Central Library of Mashhad School of Nursing and Midwifery.
Comments
Loading...