<?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>IRCT20170512033932N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of positive thinking education  on  parents of adolescents with  thalassemia</public_title>
      <acronym>-</acronym>
      <scientific_title>The effect of positive thinking education  on adaptation and life quality  in parents of teenagers with  thalassemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32127</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: The researcher provided a list of parents of thalassemic adolescents who had the conditions of the study in a simple random sampling method from those who had entered the study and randomly assigned a randomized random type according to the random allocation rule to the  two experimental and control groups were divided. The randomization unit is individual. In this study, 52 parents of thalassemic adolescents were selected randomly (sealed envelopes in the envelopes were written in letters C, M) and divided into two groups: intervention and control. Each participant was assigned a code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thalassemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention of this study is a skill-based training in ten steps, which is described in full below:                                                First step: understanding the concept of positive thinking and a brief familiarity with coping, optimism, and pessimism.                                                                              Step two: understanding how to shape thoughts and feelings. The relationship between mind and body, the effects of positive thinking and negative thinking, and the discovery of negative thoughts.                                                               Step three: positive through challenging negative thoughts, substitution, and quarrels with negative thoughts.                                                         Step four:changing the image, subjective use of constructive thinking and revitalizing believers.                                                                                   Step fifth:learning the style of optimistic and cynical documents.                                                                                    Step six: being positive through remove tension and relaxation training. Step seven: manage feeling .                                                                      Step eight: entering laughter in life and giving happiness.                                     Step nine:attention to the present And eliminating problems and negative feelings.                                                                                                            Step ten: summing up past discussions and providing solutions for tracking lessons. Intervention 2: Control group:There was no intervention for this 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>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 Data is not yet finalized.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parna Shamsai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azad university Ave.</address>
        <city>Ali abad katul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916845118</zip>
        <telephone>+98 17 3212 8035</telephone>
        <email>parnashamsai@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parna Shamsai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azad ave, Azad Univercity</address>
        <city>Aliabad katul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3223 4364</telephone>
        <email>parnashamsai@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have reading and writing skills
Having direct responsibility for patient care
Have at least one child of thalassemia</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents do not undergo psychotherapy or counseling
Parents with mental and physical disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Beta thalassemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention of this study is a skill-based training in ten steps, which is described in full below:                                                First step: understanding the concept of positive thinking and a brief familiarity with coping, optimism, and pessimism.                                                                              Step two: understanding how to shape thoughts and feelings. The relationship between mind and body, the effects of positive thinking and negative thinking, and the discovery of negative thoughts.                                                               Step three: positive through challenging negative thoughts, substitution, and quarrels with negative thoughts.                                                         Step four:changing the image, subjective use of constructive thinking and revitalizing believers.                                                                                   Step fifth:learning the style of optimistic and cynical documents.                                                                                    Step six: being positive through remove tension and relaxation training. Step seven: manage feeling .                                                                      Step eight: entering laughter in life and giving happiness.                                     Step nine:attention to the present And eliminating problems and negative feelings.                                                                                                            Step ten: summing up past discussions and providing solutions for tracking lessons.</i_keyword>
      <i_keyword>Control group:There was no intervention for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>World Health Organization Quality of Life Score Score. Timepoint: Before the interventionand after intervention. Method of measurement: Based on the total score of the quality of life.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of Styles of Coping Questionnaire. Timepoint: Before the intervention and after intervention. Method of measurement: Based on the total score of the overall style of the cart.</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>2018-04-28</approval_date>
        <contact_name>Ethics Committee for Biological Researches at the Azad University of shahrood</contact_name>
        <contact_address>Azad University Ave,Shahrood Azad University Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
