If the Program is Effective, an Educational Program Based on Emotional Intelligence can be presented as a Scientific and Simple way to promote Coping Strategies and Happiness in Epileptic Patients
Design
Randomized clinical trials, two parallel groups and three-step
Settings and conduct
The training will be conducted in the classroom at Masih Epilepsy Specialty Clinic. The questioner is collecting demographic data and completing questionnaires, and unaware about type of intervention on the units under study, this is done to blind the study to the questioner. The researcher will not be aware of the information obtained from the research units by the questioner during the study.
Participants/Inclusion and exclusion criteria
Have a medical record with diagnosis of hypertensive epilepsy and have been at least 6 months since the onset of their illness; Able to communicate; َAware of their illness and are interested in participating in the study; Having the physical and mental ability to participate in the study; aged 18-60; Lack of cognitive impairment and no other mental or physical illness; Having the ability to read and write; Not participating in other psychotherapy programs during the study; Lack of drug and psychotropic drugs; Lack of pregnancy; possibility of using Sorush's program; No major stress for the person; Unwillingness to continue studying; Absence in two sessions; Make any physical or psychological damage
Intervention groups
Teaching Emotional Intelligence in 8 sessions of 90 minutes over a period of 8 weeks (one session each week) in groups of 17-18 with a tutorial on the subject of each session and delivery of homework at the next session. For the control group, 2 training sessions will be held on the subject of epilepsy and its challenges
Main outcome variables
Effect of a program based on emotional intelligence on coping strategies and happiness in epileptic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040077N1
Registration date:2018-08-01, 1397/05/10
Registration timing:registered_while_recruiting
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Niloufar Hajisabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3661 6759
Email address
n.hajisabbagh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-11, 1397/03/21
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of a Program based on Emotional Intelligence components on Coping Strategies and Happiness in Epileptic Patients
Public title
Investigating Emotional Intelligence in Epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients at this Center have a Medical Record with Diagnosis of Grandmal Epilepsy and at least six months have passed since the onset of their Illness
Able to Communicate
They are aware of their Illness and are Interested in Participating in the Study
Having the Physical and Mental Ability to Participate in the Study
Patients are Selected from People aged 18 to 60 years
The Absence of Cognitive Impairments and the Absence of other Mental or Physical Illnesses confirmed by the Physician and according to the Medical Records of the People under Study
Having the Ability to Read and Write
Not Participating in other Psychotherapy Programs during the Study
No Drug Addiction and Psychotropic Substance
Lack of Pregnancy
Power and Possibility of Using the Sorosh Program
No major Stress for the Person during the last month or during the Session
Exclusion criteria:
Unwillingness to Continue to Participate in the Study
The Absence of a Patient in two Consecutive Sessions of Interventional Training Sessions for any Reason
Make any Physical or Psychological Damage to the People who are not Able to Attend the Meetings
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The Researcher referred to the Epilepsy Society in Consecutive days and will list the Volunteers who come to the Society with Acceptable Criteria for entering the Research. Substitution of the Samples in the Groups will then be done Randomly using the Lottery Method and each Sample will be Divided into the Control and Test Groups at the time of entering the study 1: 1. In this way, the number of 35 Cards on which the Test Word and the 35 Cards on which the Control Word written on them will be cast in a box. Each of the Samples will be asked to Select one of the Cards Randomly. Then, People with a Test Card will be Placed in the Test Group and those with a Control Card will be placed in the Control Group. It should be Noted that all Cards are the Same Size.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this Research, the Questioner was asked to collect Demographic Data and complete Questionnaires in both Groups before Intervention, Immediately after the Intervention and one month after the Intervention. The Questioner is unaware of the research units that this is done in order to Blind the Study to the Questioner. The Researcher will not be aware of the Information obtained from the Research units by the Questioner during the Study.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.MUI.REC.1396.3.138
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Coping Strategies
Timepoint
Before, Immediately, One month after the intervention
Method of measurement
Andler & Parker Coping Strategies Questionnaire
2
Description
Happiness
Timepoint
Before, Immediately, One month after the intervention
Method of measurement
Oxford Happiness Test Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention in the experimental group was implemented as Emotional Intelligence Training Program in 8 sessions of 90 minutes over a period of 8 weeks (one session per week) in groups of 17-18, using lecture, group discussion, presentation Movies and slideshows and role plays will be held in the classroom. The content of the sessions is the same for all groups and all study groups provide an educational pamphlet based on the subject of each session, and they are asked to practice the homework daily until the next session, and at the beginning of the next meeting, the discussions will be held.In addition, the researcher for the coordination of the timely presence of the research units and the presentation of the subject of each session beforehand and the possibility of asking and discussing the course during the training process, a group will be created in the Sorosh program and the units of the study group will addes into the group. It also continually monitors and controls the interval between sessions to ensure that the exercises are carried out.
Category
Rehabilitation
2
Description
Control group: in order to eliminate the possible effects of the presence of individuals in a group, 2 training sessions will be held on the topic of epilepsy and its challenges, without reference to the emotional intelligence component.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Masih Epilepsy Specialty Clinic
Full name of responsible person
ِDr. Masoud Etemadifar
Street address
Next to Masjed al-Mousaum, After alley 119, Keshavarz Blvd, Suhrawardi Intersection, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8177795137
Phone
+98 31 3777 1572
Fax
+98 31 3777 1572
Email
isfahan_epilepsy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
Isfahan, Azadi Square, Hezar Jirib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Fax
+98 31 3669 9398
Email
m.fereidooni@nm.mui.ac.ir
Web page address
http://nm.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?