<?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>IRCT20200107046044N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-30</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of teach-back method and video clip teaching on the sense of coherence of mothers with children suffering from asthma</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of teach-back method and video clip teaching on the sense of coherence of mothers with children suffering from asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44870</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Since the study population of this study is limited, eligible study participants are selected by non-probability sampling and available. After selection, participants will be randomly assigned to a block between the three groups. In other words, eligible participants will be selected by simple non-random selection, but the allocation of participants will be random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The sense of coherence of mothers with children suffering from asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: teach-back method: Training in this method will be provided by the researcher in 8 sessions, one session per week for 2 months. The training is flexible to the needs of mothers and will run face to face for 30-45 minutes. Educational content will be explained to people in a simple language, far from specific medical terms. Then, at the end of the same session, people will be given the opportunity to speak in their own language. If the material is inaccurate or inaccurate, the researcher will correct and complete the relevant training until the person has correctly returned the material to their language. will be. In other words, the return teaching score will be determined if the mother answers 75% of the questions correctly, which means that the training will be effective and otherwise the training will continue. Intervention 2: Intervention group: video clip: In this tutorial, the material stated in the return teaching method will also be included in the relevant video clip. The training is face-to-face, and the mothers will receive the necessary training by showing this video clip in two sessions. The duration of this video clip will be 15 minutes, produced by the researcher and performed with the approval of several pediatric asthma and allergy physicians, pediatric psychiatrists, pediatric nurses and psychiatric nurses. In this clip, there are questions about the material. Intervention 3: Control group: No intervention: This group will not be given training.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadsajjad mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alpha246B, Golestan1, Besat Town</address>
        <city>Bandar-e-Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6357153757</zip>
        <telephone>+98 61 5242 1065</telephone>
        <email>sajjad.mousavi2512@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadsajjad mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alpha246B, Golestan1, Besat Town</address>
        <city>Bandar-e-Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6357153757</zip>
        <telephone>+98 61 5242 1065</telephone>
        <email>sajjad.mousavi2512@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
At least one year has passed since the specialist diagnosis of child asthma
Mother's sense of cohesion with a cut-off point of 52 and below</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's Mental Illness and Chronic Physical Illness
Previous maternal participation in studies similar to current research</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: teach-back method: Training in this method will be provided by the researcher in 8 sessions, one session per week for 2 months. The training is flexible to the needs of mothers and will run face to face for 30-45 minutes. Educational content will be explained to people in a simple language, far from specific medical terms. Then, at the end of the same session, people will be given the opportunity to speak in their own language. If the material is inaccurate or inaccurate, the researcher will correct and complete the relevant training until the person has correctly returned the material to their language. will be. In other words, the return teaching score will be determined if the mother answers 75% of the questions correctly, which means that the training will be effective and otherwise the training will continue.</i_keyword>
      <i_keyword>Intervention group: video clip: In this tutorial, the material stated in the return teaching method will also be included in the relevant video clip. The training is face-to-face, and the mothers will receive the necessary training by showing this video clip in two sessions. The duration of this video clip will be 15 minutes, produced by the researcher and performed with the approval of several pediatric asthma and allergy physicians, pediatric psychiatrists, pediatric nurses and psychiatric nurses. In this clip, there are questions about the material.</i_keyword>
      <i_keyword>Control group: No intervention: This group will not be given training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sense of coherence. Timepoint: Mothers' sense of coherence at baseline (before intervention) and one month after intervention. Method of measurement: Sense of Coherence Questionnaire (SOC-13).</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-22</approval_date>
        <contact_name>Ethics Committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd, Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
