<?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>IRCT20170512033932N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Spiritual Care Based on Ghalbe Salim in children with Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Spiritual Care Based on Ghalbe Salim on Anxiety and Self-Esteem in children with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35660</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: A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group in this study is training on spiritual care and focusing on the religion of Islam for patients in five sessions (45-60 minutes per session), which are described below: session 1: Introduce and familiarize members with each other, learn about the reasons for forming a group and get acquainted with the rules of the group such as confidentiality, respect each other's opinions and tolerance of different views, number and time of meetings and the need for continuous attendance until the end of treatment. Session 2: The role of trust and recourse coping with stress caused by a child's illness. Familiarity with the theoretical foundations of recourse, stages and effects of recourse, the concept of recourse, familiarity with shrines, familiarity with the books of pilgrimage, the role of recourse in coping with stress, recourse against stress, familiarity with psychological pressure, recourse against stress, the effect of recourse on life pressure control or effective skills in recourse. Session 3: The role of prayer and supplication in solving problems and familiarity with the effect of prayer on one's relationship with God, oneself and others. Session 4: gratitude and its effect on reducing the negative emotions and teaching the effective beliefs in the effect of gratitude to reduce negative emotions. Session 5: steps of patience and training on the value of patience, patience and effective beliefs in patience, existence of a merciful God, the effect of patience on changing thoughts, patience as an effective strategy in coping with childhood illness. Intervention 2: There were no meetings for the control group. They received only routine hospital training, including several pamphlets containing brief information on disease.</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 Still, the data is not fully collated.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhde Vazifedust</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azad University, Azad Blvd.</address>
        <city>Aliabad Katul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916845118</zip>
        <telephone>+98 17 3212 8035</telephone>
        <email>mozhde.vd@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mozhde Vazifedust</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 3422 4500</telephone>
        <email>mozhde.vd@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The ability to have a suitable communication with the researcher during the initial interview.
Be willing to participate in research and be able to tolerate meetings.
Have the necessary physical and mental preparation to answer the questions.
Have at leastability to read and write
Be able to speak in Persian.
Be a Muslim and have a Shiite religion</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from mental disorders such as depression and anxiety</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D70.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Agranulocytosis secondary to cancer chemotherapy</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 in this study is training on spiritual care and focusing on the religion of Islam for patients in five sessions (45-60 minutes per session), which are described below: session 1: Introduce and familiarize members with each other, learn about the reasons for forming a group and get acquainted with the rules of the group such as confidentiality, respect each other's opinions and tolerance of different views, number and time of meetings and the need for continuous attendance until the end of treatment. Session 2: The role of trust and recourse coping with stress caused by a child's illness. Familiarity with the theoretical foundations of recourse, stages and effects of recourse, the concept of recourse, familiarity with shrines, familiarity with the books of pilgrimage, the role of recourse in coping with stress, recourse against stress, familiarity with psychological pressure, recourse against stress, the effect of recourse on life pressure control or effective skills in recourse. Session 3: The role of prayer and supplication in solving problems and familiarity with the effect of prayer on one's relationship with God, oneself and others. Session 4: gratitude and its effect on reducing the negative emotions and teaching the effective beliefs in the effect of gratitude to reduce negative emotions. Session 5: steps of patience and training on the value of patience, patience and effective beliefs in patience, existence of a merciful God, the effect of patience on changing thoughts, patience as an effective strategy in coping with childhood illness.</i_keyword>
      <i_keyword>There were no meetings for the control group. They received only routine hospital training, including several pamphlets containing brief information on disease.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Esteem Score by Cooper Smith Self-Esteem Questionnaire. Timepoint: Before the intervention begins and after intervention. Method of measurement: Based on total self-esteem score.</prim_outcome>
      <prim_outcome>En Anxiety Scale from Marx's Anxiety Inventory. Timepoint: Before the intervention begins and after intervention. Method of measurement: Based on total score of anxiety.</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>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>
