This study is a randomized clinical trial, two parallel group and two stage with test plan before and after of intervention that it will be done On 70 women referred to the clinic with multiple sclerosis MS Therapy Centre Ayatollah Kashani that will have Inclusion criteria for the study. All data will be collected with using standard questionnaires : Bar-On Emotional Intelligence, quality of life(MSQoL-54) and Multiple Sclerosis self-efficacy (MSSS).
The samples selected randomly, with written informed consent and then randomly placed in the experimental and control groups with minimization method. Then, before the intervention questionnaires will be completed in two groups. The intervention will take place in 8 sessions of 90 minutes during 8 weeks (one session per week) in small groups of 9-8 people by the researcher and using same teaching method and the content in all groups. To all the subjects offered a pamphlet on the subject of each meeting and will be asked to practice daily homework until the next meeting and researcher will continuously track and control to ensure of doing homework in between sessions by phone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120117387N4
Registration date:2016-04-11, 1395/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Fatemeh Nazari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7589
Email address
nazari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of emotional intelligence education program on self-efficacy and quality of life for women with multiple sclerosis
Public title
Effect of emotional intelligence education program on self-efficacy and quality of life for women with MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria
Women with multiple sclerosis (relapsing, primary progressive and secondary progressive) over 18 years old with a definite diagnosis of MS by a neurologist based on the McDonald's criteria ) at least one year from the time of diagnosis it is past and non-recurrent attack In the past 3 months;Having at least a high school degree; Earn less than 4.5 on the Expanded Disability Status Scale (EDSS); Emotional intelligence test score of less than 225 Bar -On (Yalcin et al, 2008); Willingness to participate in the study and placed in Test and control groups randomly;Don’t participate subjects in another similar study simultaneously;Lack of cognitive disorders, no known mental illness confirmed by a doctor and the contents of the medical records of the subjects;Lack of addiction to narcotics and psychotropic substances;Absence of pregnancy;Self-reported subjects, physical and mental ability to participate in this study.
Exclusion Criteria
Lack of desire to continue cooperation in research;The absence of a meeting during the course;Lack of active participation during the two sessions of training course.
Age
From 19 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
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
Research Vice Chancellor of Isfahan University of Medical Sciences
Street address
Isfahan - street thousand acres. Isfahan University of Medical Sciences
City
Isfahan - street thousand acres. Isfahan University of Medical Sciences
Postal code
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
ir.mui.rec.1394.3.583
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Selfefficacy
Timepoint
Before, immediately after and three months after intervention
Method of measurement
Multiple sclerosis self-efficacy questionnaire
2
Description
Quality of life
Timepoint
Before, immediately after and three months after intervention
Method of measurement
QuestionniareMultiple Sclerosis Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention will take place in 8 sessions of 90 minutes during 8 weeks (one session per week) in small groups of 9-8 people by the researcher and using same teaching method and the content in all groups. To all the subjects offered a pamphlet on the subject of each meeting and will be asked to practice daily homework until the next meeting and researcher will continuously track and control to ensure of doing homework in between sessions by phone.
Category
Rehabilitation
2
Description
The intervention will take place in the control group is a group discussion session about the disease, etiology and pharmaceutical and health care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital related to Isfahan University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Street address
Adult Health Nursing Department, School of Nursing and Midwifery Medical Sciences, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
Master of Nursing and Midwifery Faculty of Isfahan
Other areas of specialty/work
Street address
Department of Nursing Adult Health, School of Nursing and Midwifery, University of Medical Sciences, Street of a Thousand acres, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 7589
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
Master trends in nursing education
Other areas of specialty/work
Street address
Department of Nursing Adult Health, School of Nursing and Midwifery, University of Medical Sciences, Street of a Thousand acres, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 7589
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 3792 7589
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)