<?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>IRCT20190415043285N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Social adaptation and resilience of mothers of thalassemic</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Roy adaptation model  on the social adaptation and resilience of mothers of thalassemic children 7-19 years old in Gonbad city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38944</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was available from among those who were admitted to the study and randomly divided into two groups of test and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thalassemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight training sessions and presentation of pamphlets and educational CDs.The first session involves getting acquainted with the researcher and the mothers together and completing the questionnaires. The second meeting was an explanation of the incidence of thalassemia, its prevalence in Iran, the importance of family role in protecting patients, the impact of thalassemia on the family and ways to prevent it.The third session was given to mothers in relation to physiological needs such as nutrition, sleep, evolutionary needs, and the absorption and disposal of information. The fourth session was dedicated to the aspect of self-concept, which was discussed at the meeting about the importance of the mother's mental imagery, the reality of life, and the concept of self-concept and happy life.The fifth session of the role play and help to improve the roles: motherhood, fraternity, husbandry and social roles, and in the sixth session, in relation to the dimension of attachment, understanding and control of negative feelings and emotions, and reducing the positive feelings toward the problem Your child was held in a group. The seventh session was also conducted individually and individually. After the end of the sessions (eighth session), the posttest was provided to both groups and completed with the help of the researcher. Intervention 2: Control group: There is no special 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>Zeinab Rashki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ayat street</address>
        <city>aliabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3422 4500</telephone>
        <email>z_rashki@aliabadiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Hojati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayat street</address>
        <city>Aliabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49417-93451</zip>
        <telephone>+98 17 3422 4500</telephone>
        <email>h_hojjati1362@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least one thalassemia child
The desire to participate in research
Not having physical and psychological problems</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not attending two sessions of 8 sessions
Non-cooperation
Stir the meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism(D50-D89)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Eight training sessions and presentation of pamphlets and educational CDs.The first session involves getting acquainted with the researcher and the mothers together and completing the questionnaires. The second meeting was an explanation of the incidence of thalassemia, its prevalence in Iran, the importance of family role in protecting patients, the impact of thalassemia on the family and ways to prevent it.The third session was given to mothers in relation to physiological needs such as nutrition, sleep, evolutionary needs, and the absorption and disposal of information. The fourth session was dedicated to the aspect of self-concept, which was discussed at the meeting about the importance of the mother's mental imagery, the reality of life, and the concept of self-concept and happy life.The fifth session of the role play and help to improve the roles: motherhood, fraternity, husbandry and social roles, and in the sixth session, in relation to the dimension of attachment, understanding and control of negative feelings and emotions, and reducing the positive feelings toward the problem Your child was held in a group. The seventh session was also conducted individually and individually. After the end of the sessions (eighth session), the posttest was provided to both groups and completed with the help of the researcher.</i_keyword>
      <i_keyword>Control group: There is no special training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The compatibility score obtained from the Bell Compliance Inventory. Timepoint: Before and after intervention. Method of measurement: Bell compatibility questionnaire.</prim_outcome>
      <prim_outcome>A resonance score derived from the Conor Davidson questionnaire. Timepoint: Before and after intervention. Method of measurement: Conor David Sohn Resilience Questionnaire.</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>2019-03-13</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Shahroud Branch</contact_name>
        <contact_address>Shahroud Azad University shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
