<?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>IRCT20160119026104N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of peer  on stress , anxiety and depression in mothers of children with leukemia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of peer education on stress , anxiety and depression in mothers of children with leukemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Stress. Condition 3: Depression.</hc_freetext>
      <i_freetext>Intervention 1: A total of 70 children with cancer who are eligible to participate in the study will be selected using the available method and will be included in the study. After explaining the actions and obtaining the informed consent, in the first stage, "before intervention," the anxiety and stress,depression of the mothers of both intervention groups And control is measured by questionnaire. This intervention with peers run during the childhood admission of children in the hospital during the days when the conditions of the child, mother and child are allowed to run every day, which includes 4 sessions of 30 to 45 minutes in groups of 3-5 people, and a booklet prepared ; was given to the mothers of the intervention group.After the completion of the sessions, DASS-21 questionnaire will be completed  after one and two month by the intervention group participants. It should be noted that there is no intervention for the control group and they will be under the usual care of the department. At the end of the study, a booklet will be provided to the control group participants. Intervention 2: Control group:Approved instruction booklet.</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:
After Data coding in order to keep the confidentiality of the participants in the research.

When:
The end of sampling till six months after article publishing.

To whom:
Ethical, Reviewer and Editorial committees, Researchers.

Conditions:
Systematic review and meta-analysis or secondary analysis citation

Where to obtain:
Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir

How to obtain:
After sending a request to academic email, we will send our data files up to one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Shoghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave, above Vanak Square, Rashid Yasemi Ave., Iran Nursing Midwifery Faculty</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>shoghi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Shoghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>shoghi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No anti-anxiety and depression drugs
Persian language proficiency
Passed at least 6 months from the diagnosis of a child's illness
Absence in the same sessions and classes</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of psychological illness Other stressful events other than childhood during the past 6 month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.7</hc_code>
      <hc_code>Z63.7</hc_code>
      <hc_code>R68.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other stressful life events affecting family and household</hc_keyword>
      <hc_keyword>Other stressful life events affecting family and household</hc_keyword>
      <hc_keyword>Other general symptoms and signs</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A total of 70 children with cancer who are eligible to participate in the study will be selected using the available method and will be included in the study. After explaining the actions and obtaining the informed consent, in the first stage, "before intervention," the anxiety and stress,depression of the mothers of both intervention groups And control is measured by questionnaire. This intervention with peers run during the childhood admission of children in the hospital during the days when the conditions of the child, mother and child are allowed to run every day, which includes 4 sessions of 30 to 45 minutes in groups of 3-5 people, and a booklet prepared ; was given to the mothers of the intervention group.After the completion of the sessions, DASS-21 questionnaire will be completed  after one and two month by the intervention group participants. It should be noted that there is no intervention for the control group and they will be under the usual care of the department. At the end of the study, a booklet will be provided to the control group participants</i_keyword>
      <i_keyword>Control group:Approved instruction booklet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: The beginning of the study (before the study began) and one month، two month later. Method of measurement: Questionnaire DASS-21(Depression‚ Anxiety‚ Stress Scale 21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: The beginning of the study (before the study began) and one month، two month later. Method of measurement: Questionnaire DASS-21(Depression‚ Anxiety‚ Stress Scale 21).</prim_outcome>
      <prim_outcome>Depression. Timepoint: The beginning of the study (before the study began) and one month، two month later. Method of measurement: Questionnaire DASS-21 (Depression‚ Anxiety‚ Stress Scale 21).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
