<?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>IRCT2016011626043N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-11</date_registration>
      <primary_sponsor>Islamic Azad University Sari Bbranch</primary_sponsor>
      <public_title>Self- Management in Children 7-12 aged with Asthma</public_title>
      <acronym></acronym>
      <scientific_title>The Study of the Impact of Self- Management Education  on 7-12 years old childrenُs Asthma Control</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21693</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention 1: Experimental (treatment) Group: For each child before treatment, FEV1 (  Forced Expiratory Volume in One Second )would be measured using Spirometry. Then, the child would be asked to complete the demographic information and a written Action program (WAP) would be completed by the sensitivity and asthma specialist on the required orders in normal situation, before exercise and Asthmaattack that the child will act upon it during the following three months. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the child and 12 weeks after treatment FEV1(  Forced Expiratory Volume in One Second ) would be re- measured using Spirometry. Intervention 2: Control Group: For each child FEV1 (  Forced Expiratory Volume in One Second )would be done using Spirometry before any treatment and 12 weeks after that. Then the child would be asked to complete the demographic information. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the chil and 12 weeks after treatment FEV1(  Forced Expiratory Volume in One Second ) would be re- measured using Spirometry.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soghra Hasani Narenjbaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 km Sea Road Complex Islamic Azad University Sari Branch</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3303 2891</telephone>
        <email>homahasani@iausari.ac.ir</email>
        <affiliation>Islamic Azad University Sari Brabnch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soghra Hasani Narenjbaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 km Sea Road Complex Islamic Azad University Sari Branch</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3303 2891</telephone>
        <email>homahasani@iausari.ac.ir</email>
        <affiliation>Islamic Azad University Sari Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion:َ&#13;
A definitive diagnosis of Asthma by pulmonory spesialist ؛ ages 7 to 12 ؛The absence of serious systematic disease&#13;
Exclusion:&#13;
Unwillingness to cooperate during the investigation</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j45.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed Asthma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental (treatment) Group: For each child before treatment, FEV1 (  Forced Expiratory Volume in One Second )would be measured using Spirometry. Then, the child would be asked to complete the demographic information and a written Action program (WAP) would be completed by the sensitivity and asthma specialist on the required orders in normal situation, before exercise and Asthmaattack that the child will act upon it during the following three months. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the child and 12 weeks after treatment FEV1(  Forced Expiratory Volume in One Second ) would be re- measured using Spirometry</i_keyword>
      <i_keyword>Control Group: For each child FEV1 (  Forced Expiratory Volume in One Second )would be done using Spirometry before any treatment and 12 weeks after that. Then the child would be asked to complete the demographic information. The questionnaire on asthma control would be completed by the child weekly for the 12 weeks and the number of referrals to emergency and the days of absence from school would be recorded in the questionnaire by the chil and 12 weeks after treatment FEV1(  Forced Expiratory Volume in One Second ) would be re- measured using Spirometry</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FEV1(  Forced Expiratory Volume in One Second ). Timepoint: Before and 3 months after intervation. Method of measurement: percent espirometery.</prim_outcome>
      <prim_outcome>Days of Absence from School. Timepoint: Before and 3 months after intervation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>The number of referrals to emergency room. Timepoint: Before and 3 months after intervation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Asthma contorol. Timepoint: After Intervantion. Method of measurement: 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>Islamic Azad University Sari Bbranch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-11</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Department of Research and Technology of Mazandran Universitu of Medical Sciences Moalem square  Moalem  street Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
