<?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>IRCT20231128060208N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-02</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of teaching mother and child together using the teach-back method with the multimedia method, on self-care behaviors in children with type 1 diabetes.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of teaching mother and child together using the teach-back method with the multimedia method, on self-care behaviors in children with type 1 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74009</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By simple random method
In order to randomly assign the groups, 45 sheets of the same shape and size are cut and written on 15 sheets of the control group, 15 sheets of the teachback group and 15 sheets of the multimedia group, and the sheets are folded and put in a container and mixed. to be Upon admission of each patient, a sheet is removed from the container to determine the group and the patient's group is determined based on the writing on the sheet.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes type 1.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Receive routine hospital training. Intervention 2: Intervention group: Teaching self-care behaviors by the teachback method  The first session provides explanations about diabetes and its causes and complications, ways to prevent complications • The second session provides necessary training on the type of diet, meal times and snacks • The third session teaches how to inject insulin and injection sites • The fourth session Training on how to check blood sugar and its hours and foot care. At the end of each session, to ensure that the client learns the said items, open questions are asked so that the topics can be repeated if necessary. This process continues until the client learns completely. In addition, at the beginning of each session, the training items of the previous session are asked in the form of open questions so that the training items of the previous session can be repeated if necessary. At the end of the session, the taught items are provided to the client in the form of an educational pamphlet. Intervention 3: Intervention group: Teaching self-care behaviors by multimedia method • In the first session, explanations are given about diabetes and its causes and complications, ways to prevent complications• The second session of necessary training about the type of diet, the frequency of meals and snacks• The third training session on how to inject insulin and injection sites• The fourth training session on how to check blood sugar and its hours and take care of the feetIn the multimedia training group, the same content is used, but it is not presented face-to-face, instead, patients receive training videos through CDs, DVDs, and mobile device files. The content of these videos includes all the content that is taught face-to-face in the teaching 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about illness and family conditions without identifying the client
Only part of the data, such as information related to the main outcome, can be shared

When:
The access period starts one month after the publication of the article

To whom:
The opinion of researchers working in academic and scientific institutions

Conditions:
All necessary analyzes are allowed for use in research related to children's diabetes

Where to obtain:
gmai
RAHIME ZELHAGH 
RAHIME.ZELHAGH@GMAI.COM

How to obtain:
Send a request to Gmail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>rahimeh zelhagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 206, 4 Al-Ghadir St</address>
        <city>zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861733574</zip>
        <telephone>+98 915 033 0375</telephone>
        <email>rahime.zelhagh@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahime Zelhagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 206, 4 Al-Ghadir St</address>
        <city>zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861733574</zip>
        <telephone>+98 915 033 0375</telephone>
        <email>rahime.zelhagh@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>3. 6 months to a year have passed since the diagnosis of diabetes
Getting a score less than 47 from Tobert and Glasgow's diabetes self-care questionnaire (2002)
Diagnosing type 1 diabetes in a child by a doctor
Not teaching the child about diabetes during the last month
Absence of the child's parents in the medical science group
Access and ability of the child or a family member. to electronic devices such as phones or laptops
Child age 6-12
The child's absence of physical and mental illness other than diabetes (by examining the doctor's case and medical history)
Consciousness level should be based on Glasgow 15 criteria
Having a desire to participate in research
The mother should not be responsible for taking care of any patient other than diabetes in the family
The possibility of calling the child's mother
Mother's literacy
The absence of the mother suffering from mental, nervous or other known chronic diseases (according to the history taken)
Having a mother's phone or laptop and the ability to work with it</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Creating physical problems in the mother or child that prevents self-care
Withdrawal of mother and child from participating in the study
Non-cooperation of the client
Participation in self-care training sessions of other workshops or researches
Death of mother or child</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Receive routine hospital training</i_keyword>
      <i_keyword>Intervention group: Teaching self-care behaviors by the teachback method  The first session provides explanations about diabetes and its causes and complications, ways to prevent complications • The second session provides necessary training on the type of diet, meal times and snacks • The third session teaches how to inject insulin and injection sites • The fourth session Training on how to check blood sugar and its hours and foot care. At the end of each session, to ensure that the client learns the said items, open questions are asked so that the topics can be repeated if necessary. This process continues until the client learns completely. In addition, at the beginning of each session, the training items of the previous session are asked in the form of open questions so that the training items of the previous session can be repeated if necessary. At the end of the session, the taught items are provided to the client in the form of an educational pamphlet.</i_keyword>
      <i_keyword>Intervention group: Teaching self-care behaviors by multimedia method • In the first session, explanations are given about diabetes and its causes and complications, ways to prevent complications• The second session of necessary training about the type of diet, the frequency of meals and snacks• The third training session on how to inject insulin and injection sites• The fourth training session on how to check blood sugar and its hours and take care of the feetIn the multimedia training group, the same content is used, but it is not presented face-to-face, instead, patients receive training videos through CDs, DVDs, and mobile device files. The content of these videos includes all the content that is taught face-to-face in the teaching group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care behaviors. Timepoint: Before the start of the intervention  and 3 months later. Method of measurement: Toberth and Glasgow 2002 questionnaire  measurement of HBA1C.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Toberth and Glasgow 2002 questionnaire score. Timepoint: Before the intervention and one month later. Method of measurement: The average scores ranged from 0-70 and it was divided into three parts, and a general compliance score was obtained by summing the scores of each question.</sec_outcome>
      <sec_outcome>HBA1C. Timepoint: Before the intervention and 3 months later. Method of measurement: Metabolic tests (HbA1C) in children are all done in the same laboratory. The reliability of the laboratory instrument will be checked by checking the calibration of the device every time the device is used. Also, all the tests will be performed in the same environment and by a specific person and device.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-14</approval_date>
        <contact_name>Zabol University of Medical Sciences</contact_name>
        <contact_address>Zabol, Jihad Square, Shahid Bagheri St., Zabol University of Medical Sciences Headquarters Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
