<?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>IRCT20230709058732N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of group education  on controlling  of seizure attacks in children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of group education of parents on controlling the recurrence of seizure attacks in children 6 months to 5 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71217</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples were first selected from the research community based on the inclusion criteria. The random assignment of the research sample to two intervention and control groups will be done based on permutation blocks of four (using the table related to random blocks). In this method, the people assigned to each group are equal. The blocks are formed based on the desired variables and half of the people in each block are included as intervention and half as control. The main goal is to balance the number of participants in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Seizure (convulsive).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the test group, educational intervention in the form of (face-to-face and showing educational videos and educational sessions approved by the doctor) will be carried out by the researcher during 10 sessions of 45 minutes, 1 session per week. In order to apply the educational method, the educational content is prepared based on the educational goals and by using authentic books and consultation with a doctor specializing in seizures. Educational content will be presented to parents first through face-to-face method and then through videos and other educational methods during training sessions.The educational content includes the definition of seizures, classification and types of seizures (simple, complex), duration of each type of seizure, symptoms of seizures, probability of recurrence, causes and risk factors of seizures, complications caused by seizures, treatment methods, drugs and methods Taking medicines, feeding the child, in case of fever, fever control methods, the correct method of application, ways to prevent convulsions and education about convulsion-accelerating factors (flashing light, lack of sleep, excessive activity, exercise, physical factors).Among other things, teaching precautions at home, interventions during seizures (the correct position of the child during an attack, removing tight and restricting clothes, giving the opportunity to perform spontaneous convulsive movements, not putting anything in the child's mouth, not trying to restrict sedating the child, using suppositories, calling the emergency center if the seizure lasts more than five minutes or repeats the attacks or the child's lack of consciousness after stopping the convulsive movements. After the intervention, a checklist will be provided to parents to check their performance at home to control children's seizures within a month. Intervention 2: Control group: No educational intervention will be done for the control group, but in order to comply with the ethical points, pamphlets and educational booklets will be provided to the control group after the analysis of the study results.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashraf al-Sadat Hakim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University., Esfand Street., Golestan Blvd., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6173333183</zip>
        <telephone>+98 61 3337 3813</telephone>
        <email>hakim3448200@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashraf al-Sadat Hakim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University., Esfand Street., Golestan Blvd., Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6173333183</zip>
        <telephone>+98 61 3337 3813</telephone>
        <email>hakim3448200@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main conditions for entering the study before randomization include: 1. Having an age of six months to five years for children with seizures
2. Parents must have minimum reading and writing literacy or mental and intellectual ability to participate in educational programs and complete the questionnaire</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents' unwillingness to participate in the research
Parents suffering from physical or mental disorders based on self-report
Parents' non-participation in 2 training sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R56.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Seizure (convulsive) NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the test group, educational intervention in the form of (face-to-face and showing educational videos and educational sessions approved by the doctor) will be carried out by the researcher during 10 sessions of 45 minutes, 1 session per week. In order to apply the educational method, the educational content is prepared based on the educational goals and by using authentic books and consultation with a doctor specializing in seizures. Educational content will be presented to parents first through face-to-face method and then through videos and other educational methods during training sessions.The educational content includes the definition of seizures, classification and types of seizures (simple, complex), duration of each type of seizure, symptoms of seizures, probability of recurrence, causes and risk factors of seizures, complications caused by seizures, treatment methods, drugs and methods Taking medicines, feeding the child, in case of fever, fever control methods, the correct method of application, ways to prevent convulsions and education about convulsion-accelerating factors (flashing light, lack of sleep, excessive activity, exercise, physical factors).Among other things, teaching precautions at home, interventions during seizures (the correct position of the child during an attack, removing tight and restricting clothes, giving the opportunity to perform spontaneous convulsive movements, not putting anything in the child's mouth, not trying to restrict sedating the child, using suppositories, calling the emergency center if the seizure lasts more than five minutes or repeats the attacks or the child's lack of consciousness after stopping the convulsive movements. After the intervention, a checklist will be provided to parents to check their performance at home to control children's seizures within a month.</i_keyword>
      <i_keyword>Control group: No educational intervention will be done for the control group, but in order to comply with the ethical points, pamphlets and educational booklets will be provided to the control group after the analysis of the study results.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Seizure (convulsive). Timepoint: Before the start of the intervention and one month after the intervention. Method of measurement: A combined questionnaire including a researcher-made questionnaire and an original 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-01</approval_date>
        <contact_name>Jundishapur University of Medical Sciences., Ahvaz</contact_name>
        <contact_address>University of Medical Science., Esfand Street., Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
