<?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>IRCT20151019024594N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-31</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Training Mothers of young children Based on Gagne's Model Regarding Management of Domestic Injuries</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Training Intervention Based on Gagne's Model on Knowledge, Performance, and Decision Making Power of Mothers of young children Regarding Management of Domestic Injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: -, Randomization description: After getting the necessary permissions from the authorities in question and getting consent from the mothers for participating in the study, the kindergartens of Rasht and the samples will be selected randomly using a two stage cluster sampling. In the first stage, cluster sampling will be conducted using the list obtained from Guilan Welfare Organization, according to which 132 active kindergartens work in Rasht, and according to random numbers table and from each geographical point of Rasht (north, south, center, east and west), one kindergarten will be selected as the intervention and one kindergarten as a the control. Overall, 10 kindergartens will be sampled for intervention and control groups. Then, in the second stage of cluster sampling, in the selected kindergartens, given the register and with the help of random numbers table, the children from 3 to 5 will be selected and by holding a meeting to introduce the present study, we will talk with the mothers of these children on the participation in the study. Finally, in each of the two intervention and control groups, 55 subject with the inclusion criteria will be selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: burning. Condition 2: poisoning. Condition 3: fall. Condition 4: choking.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this research, intervention is an educational type. Training sessions will be held for mothers of the intervention group for two sessions in two consecutive days in groups of 5 or 6, and for 90 minutes, using Gagne's model step by step protocols for home injuries in young children. According to the pediatric medical and nursing resources and researches, injuries of falling and falling, poisoning, burning, foreign body swallowing, and choking are the most common domestic injuries in young children, so in this study, these same injuries are also taught to teach how Prevention of injury and training after they occur. It should be noted that on the first day of training the goals associated with burn injuries and falling from the high and on the day two goals associated with the damage to the poisoning and ingestion of foreign body and choking will be implemented. Intervention 2: Control group: The mothers in control group will not be provided with any training course. However, following the end of the training sessions for the mothers in intervention group, for ethical reasons, the training booklet will be further provided to the mothers in control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Zahra Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Faculty of Nursing and Midwifery, Student Street, Shahid Beheshti Highway, Rasht, Guilan, Islamic Republic of Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>shafipur@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Zahra Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Faculty of Nursing and Midwifery, Student Street, Shahid Beheshti Highway, Rasht, Guilan, Islamic Republic of Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5058</telephone>
        <email>shafipur@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers of young children (3 to 5 year old)
A minimum level of education for mothers, high school diploma
Consent to participate in the study
Mother's health in terms of psychological disorders, communication problems and physical disability
Child's health in terms of psychological disorders, developmental, physical, and cognitive delays
Parents' employment and education in non medical sciences</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction with participating in any stage of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T29</hc_code>
      <hc_code>X40</hc_code>
      <hc_code>W13</hc_code>
      <hc_code>W79</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury, poisoning and certain other consequences of external causes</hc_keyword>
      <hc_keyword>External causes of morbidity and mortality</hc_keyword>
      <hc_keyword>External causes of morbidity and mortality</hc_keyword>
      <hc_keyword>External causes of morbidity and mortality</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this research, intervention is an educational type. Training sessions will be held for mothers of the intervention group for two sessions in two consecutive days in groups of 5 or 6, and for 90 minutes, using Gagne's model step by step protocols for home injuries in young children. According to the pediatric medical and nursing resources and researches, injuries of falling and falling, poisoning, burning, foreign body swallowing, and choking are the most common domestic injuries in young children, so in this study, these same injuries are also taught to teach how Prevention of injury and training after they occur. It should be noted that on the first day of training the goals associated with burn injuries and falling from the high and on the day two goals associated with the damage to the poisoning and ingestion of foreign body and choking will be implemented.</i_keyword>
      <i_keyword>Control group: The mothers in control group will not be provided with any training course. However, following the end of the training sessions for the mothers in intervention group, for ethical reasons, the training booklet will be further provided to the mothers in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge score of mothers of young children in researcher made questionnaire. Timepoint: Before the intervention, immediately after the intervention and 21 days after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Performance score of mothers of young children in researcher made questionnaire. Timepoint: Before the intervention, immediately after the intervention and 21 days after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Decision making power score of mothers of young children in researcher made questionnaire. Timepoint: Before the intervention, immediately after the intervention and 21 days after the intervention. 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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-25</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Shahid Siadati St., Namjoo Ave, Guilan, Rasht, Islamic Republic of Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
