<?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>IRCT2016052425713N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Spirituality on caregiver's stress and quality of life of children with leukemia</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Spiritual Support on caregiver's stress and quality of life of children aged 8 to12 with leukemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21456</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: By randomized table.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Leukemia.</hc_freetext>
      <i_freetext>Intervention 1: No intervention is made for control group. Intervention 2: Intervention group: will participate in 5 sessions of sixty minutes each day based on Richards and Bergin pattern focusing on the Islamic rituals and including psycho-spiritual components such as: prayer, trust and appeal, patience, gratitude and forgiveness. In the first session, participants will be asked to put forward their supportive needs in terms of personal experience. During the second session caregivers will be familiar with the role of trust and appeal in getting along with psychological stress caused by child disease and will be trained to know the theoretical bases of trust and appeal, trust as a contrastive strategy to deal with stress, ways to achieve the trust and appeal and How one can use trust and appeal as effective contrastive strategy to convert inappropriate negative excitements to negative excitements. In the third session the role of prayer in solving their problems and the impact of prayer on the process of problem solving is discussed. Also some instructions will be given about the value and importance of prayer, its philosophy, familiarity with the correct practical way of praying, And familiarity with the effects of prayer on the relationship of the individual with God, oneself and others. In the fourth session they will be familiar with the concept of thanksgiving and its effect on reducing negative excitements and effective beliefs will be taught about thanksgiving´s effect to decrease caregivers ´negative excitements and in the last session they will be familiar with the steps of patience and they will be taught about the value of patience, kinds of patience, steps of patience and patience as a strategy to deal with the pressures caused by the child´s illness.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Zafarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Doctora Crossroads, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 51 3341 4883</telephone>
        <email>zafarianme921@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>HamidReza Behnam Vashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ebne Sina St, Doctora Crossroads, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>BehnamHR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having informed written consents, Having Iranian citizenship, Residing in Mashhad and the surrounding areas, Having literacy, Not suffering from known mental illnesses, A confirmed diagnosis of Acute lymphoblastic leukemia by doctor. &#13;
Exclusion criteria: The unwillingness of the individual to participate in the study, Occurrence of an emergency interfering situation in the continuation of the project, Receiving a comprehensive educational program.</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D72.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of white blood cells</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>No intervention is made for control group</i_keyword>
      <i_keyword>Intervention group: will participate in 5 sessions of sixty minutes each day based on Richards and Bergin pattern focusing on the Islamic rituals and including psycho-spiritual components such as: prayer, trust and appeal, patience, gratitude and forgiveness. In the first session, participants will be asked to put forward their supportive needs in terms of personal experience. During the second session caregivers will be familiar with the role of trust and appeal in getting along with psychological stress caused by child disease and will be trained to know the theoretical bases of trust and appeal, trust as a contrastive strategy to deal with stress, ways to achieve the trust and appeal and How one can use trust and appeal as effective contrastive strategy to convert inappropriate negative excitements to negative excitements. In the third session the role of prayer in solving their problems and the impact of prayer on the process of problem solving is discussed. Also some instructions will be given about the value and importance of prayer, its philosophy, familiarity with the correct practical way of praying, And familiarity with the effects of prayer on the relationship of the individual with God, oneself and others. In the fourth session they will be familiar with the concept of thanksgiving and its effect on reducing negative excitements and effective beliefs will be taught about thanksgiving´s effect to decrease caregivers ´negative excitements and in the last session they will be familiar with the steps of patience and they will be taught about the value of patience, kinds of patience, steps of patience and patience as a strategy to deal with the pressures caused by the child´s illness.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver's stress. Timepoint: Before and after the intervention. Method of measurement: DASS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life of children. Timepoint: Before and 1 month after the intervention. Method of measurement: Teenagers'quality of life  questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-14</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for research, Ghoraishy Building, University St, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
