<?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>IRCT2017012831522N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-20</date_registration>
      <primary_sponsor>Vice Chancellor for research of Saveh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education According to planned behavioral theory on mouth and tooth health in primary students</public_title>
      <acronym>-</acronym>
      <scientific_title>The Effect of planned behavioral theory training on behaviors that associated with mouth and tooth health in primary students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>520</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The samples were randomly placed in two groups.&#13;
If the first sample is girl, the sample placed in intervention group and after the samples alternative (one to one) placed in control and intervention groups and if the first sample is boy, the sample placed in control group and after the samples alternative (one to one) placed in intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mouth and tooth health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groups: The samples of intervention group training at 3 sessions of 40 minutes in the form of lectures, group discussions and practical view.&#13;
Educational content classes includes:&#13;
First session: raising awareness and attitude,&#13;
Second session: the importance of perceived behavioral control on empowerment&#13;
And third Session: Practical showing the correct way of brushing and flossing and practice on themselves. Intervention 2: Control group: samples of the control group as well as samples of the intervention group (without participation in the educational classes) to complete the questionnaires.</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>Vahid Naseri Salahshour, MSc of Nursing Education in Medical Surgical Field</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3918698786</zip>
        <telephone>+98 86 4230 1291</telephone>
        <email>v.naserisalahshour@arakmu.ac.ir</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Naseri Salahshour (MSc of Nursing Education in Medical Surgical Field)</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saveh University of Medical Sciences, Madar Sq, SHariati st, Saveh</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3918698786</zip>
        <telephone>+98 86 4230 1291</telephone>
        <email>v.naserisalahshour@arakmu.ac.ir</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willingness to participate in the study; fourth to sixth primary school students; without learning disorders such as ADHD and autism; without attending similar training.&#13;
Exclusion criteria: reluctance to continue to participate in the study; school managers opposing to participate of students in the study; reluctance of parents to participate of students in the study; irregular participation in training classes.</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other procedures for purposes other than remedying health state</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groups: The samples of intervention group training at 3 sessions of 40 minutes in the form of lectures, group discussions and practical view.&#13;
Educational content classes includes:&#13;
First session: raising awareness and attitude,&#13;
Second session: the importance of perceived behavioral control on empowerment&#13;
And third Session: Practical showing the correct way of brushing and flossing and practice on themselves.</i_keyword>
      <i_keyword>Control group: samples of the control group as well as samples of the intervention group (without participation in the educational classes) to complete the questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Observance of mouth and tooth health. Timepoint: The questionnaire immediately after the intervention and one month after it is completed by samples of two experimental and control groups. Method of measurement: The seven-part questionnaire including: knowledge, attitude, subjective norm, perceived behavioral control, intention and behavior.</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>Vice Chancellor for research of Saveh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-26</approval_date>
        <contact_name>Ethics committee of Saveh University of Medical Sciences</contact_name>
        <contact_address>Saveh University of Medical Sciences, Madar Sq, SHariati St, Saveh Saveh  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
