<?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>IRCT20190312043028N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-13</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational program on understanding the uncertainty of the disease and anxiety of mothers of children with seizure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational program on understanding the uncertainty of disease and anxiety in mothers of children with febrile convulsion in the paediatric ward of Imam Ali Hospital in Zahedan in 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38246</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simplistic randomisation available.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of educational program on understanding the uncertainty of the disease and the anxiety of mothers of children with seizure associated with fever.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The onset of intervention begins at the time of admission and after admission. The training intervention will be designed to provide educational content based on educational objectives and with the use of a pediatric pediatric neurologist, which includes a simple definition of febrile seizure, causes, prevalence, symptoms, probability Recurrence, prognosis and treatment and drug therapy, prevention methods, diagnostic methods, methods for controlling fever, feeding and educating the mother when discharge is an anxiety control way. The intervention includes: Individual training and providing a training booklet and providing a training CD for seizure control and a practical demonstration of the child's body temperature with a thermometer and a practical demonstration of spitting. And the duration of the training will be given to the mothers for at least 30 minutes to 45 minutes, individually and face-to-face with questions and answers within the department. The number of sessions in this section will be based on the patient's requirements and conditions three times a day and one Meanwhile, three sessions were considered in one week. The time of the session is after admission. The place of intervention in theoretical debates in the classroom and in practical discussions on the patient's bedside (in the condition of a mother's relaxation and admission conditions). The educator will be a researcher. The researcher also provided the intervention group's mothers with their telephone number to contact the researcher if they had a question and the researcher would follow them up for a month. The questionnaires will be filled in by the mothers before and after the intervention in both intervention and control groups and immediately after the intervention and after one month follow up after discharge (by telephone and coordination with the mother). Training sessions are as follows: Session 1: Introducing the researcher, providing a simple definition of febrile seizure, causes, prevalence, symptoms, relapse, prognosis and treatment, and drug therapy. Session 2: Prevention Methods, Diagnostic Methods, Fever Control Methods, Maternal Education When Dispensing. Session Three: Anxiety Control Ways. Intervention 2: Control group: In the control group only routine care was provided.</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:
The total potential data after being unidentifiable are those that can be shared

When:
Start the access period after printing the results

To whom:
Researchers working in academia, academia and industry

Conditions:
Data can be used to conduct further research with the mention of the portal

Where to obtain:
Zeinab Rezaei
zeinabrezaei2711@gmail.com

How to obtain:
After reviewing the request, data is sent within 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan University of Medical Sciences, Medical Sciences Campus, Dr. Hesabi Campus</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 543295744</telephone>
        <email>zeinabrezaei2711@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan University of Medical Sciences, Medical Sciences Campus, Dr. Hesabi Campus</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3329 5744</telephone>
        <email>zeinabrezaei2711@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>There is no other illness other than seizure associated with fever.
The mother is not a hospital staff.
The mother is fluent in Persian.
The mother will have read and write literacy.
Samples will reside in Zahedan.
Have a child admitted at the age of 6 months to 6 years old with seizure.
There is no history of epilepsy in the child and the family.
The mother has no history of anxiety and depression disorders or the mother is not being treated with psychiatric drugs.
The first childhood admission.</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Did not attend more than one session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G40.901</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Epilepsy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The onset of intervention begins at the time of admission and after admission. The training intervention will be designed to provide educational content based on educational objectives and with the use of a pediatric pediatric neurologist, which includes a simple definition of febrile seizure, causes, prevalence, symptoms, probability Recurrence, prognosis and treatment and drug therapy, prevention methods, diagnostic methods, methods for controlling fever, feeding and educating the mother when discharge is an anxiety control way. The intervention includes: Individual training and providing a training booklet and providing a training CD for seizure control and a practical demonstration of the child's body temperature with a thermometer and a practical demonstration of spitting. And the duration of the training will be given to the mothers for at least 30 minutes to 45 minutes, individually and face-to-face with questions and answers within the department. The number of sessions in this section will be based on the patient's requirements and conditions three times a day and one Meanwhile, three sessions were considered in one week. The time of the session is after admission. The place of intervention in theoretical debates in the classroom and in practical discussions on the patient's bedside (in the condition of a mother's relaxation and admission conditions). The educator will be a researcher. The researcher also provided the intervention group's mothers with their telephone number to contact the researcher if they had a question and the researcher would follow them up for a month. The questionnaires will be filled in by the mothers before and after the intervention in both intervention and control groups and immediately after the intervention and after one month follow up after discharge (by telephone and coordination with the mother). Training sessions are as follows: Session 1: Introducing the researcher, providing a simple definition of febrile seizure, causes, prevalence, symptoms, relapse, prognosis and treatment, and drug therapy. Session 2: Prevention Methods, Diagnostic Methods, Fever Control Methods, Maternal Education When Dispensing. Session Three: Anxiety Control Ways</i_keyword>
      <i_keyword>Control group: In the control group only routine care was provided</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Impact of educational program on understanding the uncertainty of the disease. Timepoint: Start of training sessions from the start of admission after admission. The training sessions were held in 3 sessions and one day apart. Method of measurement: A three-part questionnaire including demographic information, Spielberg's apparent anxiety questionnaire and parents' perception of uncertainty questionnaire.</prim_outcome>
      <prim_outcome>The effect of educational program on the anxiety of mothers of children with seizure. Timepoint: A three-part questionnaire including demographic information, Spielberg's apparent anxiety questionnaire and parents' perception of uncertainty. Method of measurement: Spill bugger's Clear Anxiety Inventory.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-17</approval_date>
        <contact_name>Ethical Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Zahedan University of Medical Sciences, Dr Hasabi Campus Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
