<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180612040077N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating Emotional Intelligence in Epilepsy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of a Program based on Emotional Intelligence components on Coping Strategies and Happiness in Epileptic Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, 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 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Epilepsy.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Tez

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
In order to influence the care and treatment

Where to obtain:
Niloufar Hajisabbagh, niloufar.hajisabbagh@gmail.com

How to obtain:
SMS or Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloufar Hajisabbagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Third Floor, Diba Complex, Shahid Amini Nezhad Street, Sheikh Sadoogh Shomali Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8167719986</zip>
        <telephone>+98 31 3661 6759</telephone>
        <email>niloufar.hajisabbagh@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malek Fereidooni Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Nursing Department, Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7586</telephone>
        <email>m.fereidooni@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Epilepsy and recurrent seizures</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping Strategies. Timepoint: Before, Immediately, One month after the intervention. Method of measurement: Andler &amp; Parker Coping Strategies Questionnaire.</prim_outcome>
      <prim_outcome>Happiness. Timepoint: Before, Immediately, One month after the intervention. Method of measurement: Oxford Happiness Test Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-10</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jirib Ave, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
