<?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>IRCT20210110049988N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-24</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Stress Management on Blood Sugar</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Stress Management Workshop for Mothers of Children With Type 1 Diabetes on Their Children's Blood Sugar</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization - Easy sampling of diabetic children, type 1 diabetes referred to Amirkabir Hospital in Arak and doctor's office (Dr. Mohammad Ahangar Davoodi) in 2021, 48 people were randomly selected and divided into two groups using the Orib Coin method.
In the Orib Coin method, a dice and a coin are required. To place people in the control and intervention groups, first a coin is thrown, if it is a line, a dice is thrown, and if it is 1 to 3, the person is placed in the control group. For the second time in the intervention group, the dice that were thrown must be between 3 and 4 in order for the person to be in the intervention group. In the same way, 48 people will be divided until the end.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers with diabetic children, stress management workshop, during 8 face-to-face sessions, PowerPoint presentation and educational video. Intervention 2: Control group: Control group: Mothers with diabetic children, without stress management workshop.</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:
Information such as age, mean blood sugar in children before and after educational interventions and the effect of stress management workshop on stress and blood sugar in children

When:
Access period starts from 1400

To whom:
Researchers working in academic institutions and hospitals

Conditions:
Provided with proper and ethical use to reduce the stress of mothers with children with diabetes and referral to information is free access.

Where to obtain:
Masoumeh Adavi, 09189596008

How to obtain:
Send first and last name, field of study, university of study, type of requested data, via SMS

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Adavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Atlasi</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819867331</zip>
        <telephone>+98 86 3413 3061</telephone>
        <email>adavimasoomeh@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ganja</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alam al-Huda street; Shahid Shiroodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>pooran.ganjeh@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers' inclusion criteria: Having a child with type 1 diabetes who is at least three months old at the time of diagnosis, willingness to participate in reading, literacy.
Inclusion criteria for children: Having type 1 diabetes that is at least three months after diagnosis.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Criteria for non-inclusion of mothers: acute and chronic disorders (with emphasis on psychiatric disorders); Being a single parent, the existence of another crisis in the family.
Criteria for non-inclusion of children: history of other acute and chronic diseases in the past, co-occurrence of other acute and chronic diseases at the same time, presence of congenital or chromosomal disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus without complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers with diabetic children, stress management workshop, during 8 face-to-face sessions, PowerPoint presentation and educational video</i_keyword>
      <i_keyword>Control group: Control group: Mothers with diabetic children, without stress management workshop</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Baby blood sugar. Timepoint: 3 monthsBefore starting the study. After completing the stress management classes and a month later. Method of measurement: Glucometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mothers' stress. Timepoint: Before the start of the study, after completing the stress management classes, and a month later. Method of measurement: Cohen Perceived Stress Questionnaire.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Shahid Shiroodi arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
