<?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>IRCT20180121038467N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of empowerment of mothers on the prevention of complications of chemotherapy in children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mothers' empowerment training on prevention of chemotherapy complications in children with cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: 58/5000In this study, a 4-part empowerment model was used, Randomization description: A simple randomized case that uses a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of chemotherapy complications in children under chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: In the experimental group, training was conducted based on the steps of empowerment model in 5 one-hour sessions, the steps of which were as follows: Step One: This step was conducted by a researcher in two sessions of one hour by lecture and group discussion with the aim of increasing knowledge And understanding and then understanding the threat through awareness of the nature and complications of the disease, exacerbating factors and important points of control and prevention of complications and effective factors in controlling the disease, and in particular infection control. PowerPoint, and pamphlet were used at this stage. Mothers were divided into four groups of five. Step two: This phase was conducted with group discussion during 3 sessions of one hour. At this stage, mothers were faced with a real problem. The experiences of each other were known to solve the problems of chemotherapy and its better control, and there were concrete examples of the situation of the child and what they did to improve the problem. The purpose of the meeting was to increase the self-esteem, self-esteem and self-control of mothers. The best solution for solving children's problems was choosing the appropriate nutrition style and infection control, preventing complications by lecture method. Step 3: At the end of each session, patients were asked to promote self esteem and self-esteem through the educational participation, the topics discussed in Educational sessions were shared with the exchange of information, and a number of questions were asked by the researcher of the mothers and a booklet was given to them and the mothers were asked to explain the information to other members of the family. Step Four: To evaluate before each session Ask questions about the topics discussed to ensure you learn the content SAT took place then gave moms an opportunity during this period By placing the phone, the researcher solved the questions posed by the mother in implementing the empowerment model. Intervention 2: Control group: "There was no intervention for the control group and ethically, after the completion of the research, all educational issues were distributed as CDs and educational manuals and provided to the 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>Justification or reason for indecision in sharing IPD is Is still under review</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shams al-Muluk Jalal Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Shariati Avenue, Quds Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2951, 1994</zip>
        <telephone>+98 21 6645 4983</telephone>
        <email>leilalashkari872@gimal.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shams al-Muluk Jalal Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Shariati Avenue, Quds Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2951, 1994</zip>
        <telephone>+98 21 6645 4983</telephone>
        <email>leilalashkari872@gimal.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>For a child, chemotherapy has begun
Mother has mental health
Mother has no debilitating illness
Do not pass specific educational courses such as chemotherapy classes</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mothers with chronic diseases
Children who, in addition to cancer, have another chronic illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: In the experimental group, training was conducted based on the steps of empowerment model in 5 one-hour sessions, the steps of which were as follows: Step One: This step was conducted by a researcher in two sessions of one hour by lecture and group discussion with the aim of increasing knowledge And understanding and then understanding the threat through awareness of the nature and complications of the disease, exacerbating factors and important points of control and prevention of complications and effective factors in controlling the disease, and in particular infection control. PowerPoint, and pamphlet were used at this stage. Mothers were divided into four groups of five. Step two: This phase was conducted with group discussion during 3 sessions of one hour. At this stage, mothers were faced with a real problem. The experiences of each other were known to solve the problems of chemotherapy and its better control, and there were concrete examples of the situation of the child and what they did to improve the problem. The purpose of the meeting was to increase the self-esteem, self-esteem and self-control of mothers. The best solution for solving children's problems was choosing the appropriate nutrition style and infection control, preventing complications by lecture method. Step 3: At the end of each session, patients were asked to promote self esteem and self-esteem through the educational participation, the topics discussed in Educational sessions were shared with the exchange of information, and a number of questions were asked by the researcher of the mothers and a booklet was given to them and the mothers were asked to explain the information to other members of the family. Step Four: To evaluate before each session Ask questions about the topics discussed to ensure you learn the content SAT took place then gave moms an opportunity during this period By placing the phone, the researcher solved the questions posed by the mother in implementing the empowerment model.</i_keyword>
      <i_keyword>Control group: "There was no intervention for the control group and ethically, after the completion of the research, all educational issues were distributed as CDs and educational manuals and provided to the control group"</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complications of chemotherapy. Timepoint: The second week, the fourth week, the eighth week. Method of measurement: check list.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-26</approval_date>
        <contact_name>Ethics Committee on Research in Azad University, Tehran Medical Sciences Branch</contact_name>
        <contact_address>8, Kiani Alley, Imam Hossein Square, Damavand St. Bahrami Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
