<?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>IRCT20181117041680N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Children with Cancer</public_title>
      <acronym>خالی</acronym>
      <scientific_title>The Effect of Cognitive-Behavioral Art-Play Therapy, and Cognitive-Behavioral Story Therapy on Pain Perception, Hope, Quality of life, Anxiety and depression among Children with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample Children are selected purposefully, will be assigned to one of the three groups of Art-Play Therapy, Story Therapy, and Control or Testimonial in a random manner(lottery).(Random Assignment), Blinding description: The experimental group, the group of Cognitive-Behavioral Art-Play Therapy, was grouped in 12 sessions of 60 to 90 minutes and the Cognitive-Behavioral Story Therapy Group was treated as a weekly two session for 12 sessions of 90 minutes.The control group will not receive any treatment during this period. In the present study, the results of research implementation with identifiable code are available only to the researcher for the data analyzer and the safety committee and data monitoring. Therefore, these individuals will not be aware of what information is collected about which group and variables. Participants will also not get any information about which variables are being used and how they are clearly and precisely determined by which type of treatment they use from the two treatments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: children with cancer. Condition 2: Pain Perception. Condition 3: hope. Condition 4: quality of life. Condition 5: anxiety. Condition 6: depression.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: The Cognitive-Behavioral Art-Play Therapy Group of 15 patients randomly assigned to this group are treated for 12 sessions at 90 minutes for two months. Intervention 2: Second intervention group: The group of Cognitive-Behavioral Story Therapy, which was randomly assigned to 15 individuals randomly assigned to this group, was treated for 12 sessions at 90 minutes for two months. Intervention 3: Control group: This group of 15 randomly selected individuals in this group will receive no treatment for two months. At the same time, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of  Cognitive-Behavioral Art-Play Therapy or Cognitive-Behavioral Story Therapy.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is ethical commitment to participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology and Educational Sciences, Islamic Azad University, Isfahan (Khorasgan)</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-29998</zip>
        <telephone>+98 31353540019</telephone>
        <email>zohreh_shojaei100@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Golparvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology and Educational Sciences, Islamic Azad University, Isfahan (Khorasgan)</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-29998</zip>
        <telephone>+98 31353540019</telephone>
        <email>mgolparvar@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Conscious consent to participation in research (by parent and child)
-Age Range 8 to 12 years(children of primary school age)
-No drug used to reduce anxiety and depression
-No other physical and mental illness
-In the life of the parents and the lives of both parents with the child
-Cancer children are undergoing chemotherapy or have completed the course of chemotherapy
-Both sexes(girl and boy).</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>-Unwillingness to attend or refuse to continue working
-Sick children who are not able to attend in meetings
-Children staying in hospital for less than a week</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C79.9</hc_code>
      <hc_code>R30.9</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code>F41.9</hc_code>
      <hc_code>F38.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Secondary malignant neoplasm of unspecified site</hc_keyword>
      <hc_keyword>Painful micturition, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Other recurrent mood [affective] disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: The Cognitive-Behavioral Art-Play Therapy Group of 15 patients randomly assigned to this group are treated for 12 sessions at 90 minutes for two months.</i_keyword>
      <i_keyword>Second intervention group: The group of Cognitive-Behavioral Story Therapy, which was randomly assigned to 15 individuals randomly assigned to this group, was treated for 12 sessions at 90 minutes for two months.</i_keyword>
      <i_keyword>Control group: This group of 15 randomly selected individuals in this group will receive no treatment for two months. At the same time, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of  Cognitive-Behavioral Art-Play Therapy or Cognitive-Behavioral Story Therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain perception-The range of test scores between 0 to 10 and the higher scores represent the greater pain perception of the accountable person. Timepoint: Measurment of pre-test pain perception(pre-test) and post test(post-test). Method of measurement: Oucher Scale.</prim_outcome>
      <prim_outcome>Hope -The range of test scores between 6 to 36 and the higher scores represent the greater hope of the accountable person. Timepoint: Measurment of pre-test hope (pre-test) and post test(post-test). Method of measurement: Children and adolescent's hope scale.</prim_outcome>
      <prim_outcome>Quality of life - The range of test scores between 0 to 100 and the higher scores. Timepoint: Measurment of pre-test quality of life (pre-test) and post test(post-test). Method of measurement: Child quality of life scale(kid-KINDL).</prim_outcome>
      <prim_outcome>Anxiety - The range of test scores between 0 to 114 and the higher scores. Timepoint: Measurment of pre-test anxiety (pre-test) and post test(post-test). Method of measurement: Spence children anxiety scale.</prim_outcome>
      <prim_outcome>Depression - the smallest average used for diagnose non-depressed children is 60. so subjects with a score of 84 and above are known to be depressed. Timepoint: Measurment of pre-test depression (pre-test) and post test(post-test). Method of measurement: Child depression scale - abbreviated.</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>2018-06-03</approval_date>
        <contact_name>Ethics Committee in Biomedical Reseaches of Isfahan Azad University (Khorasgan)</contact_name>
        <contact_address>university Blvd- Arghavaniyeh- East Jey- Esfahan esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
