<?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>IRCT20190512043576N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of child-centered play therapy on resiliency and emotion regulation of children with cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of child-centered play therapy on resiliency and emotion regulation of children with cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>37</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: During a call to all parents of chidren with leukemia cancer in the blood clinic and the hospital's blood department, was invited to participate in the research project. by the approval of the head of the Department of Blood and the Supervisor, the registration of all volunteers was carried out for two weeks. Among the volunteers were 30 boys and girls aged  between 9 to 12 years with an average age of 10 years, according to the criteria for entry and exit (previously mentioned) from Ali Asghar Children's Hospital (Blood Department), with a medical diagnosis of leukemia ,They were selected for chemotherapy and fill in demographic data form (including: name, surname, age, marital status, education, work and phone nummber), child information form and consent to participate in the study. The control and experiment groups were divided into two groups (n = 15), Randomization description: Simple randomization using drawing from the list of volunteers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children Leukemia Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Intervention of this research is based on a child-centered play therapy approach and is based on a client-centered  treatment. Play materials(selected on the basis of Landreth  principles) are provided by the therapist to create a safe and free environment for the child, then the child is helped to  rebuild the traumatic event with toys so tha the child revisit and process thoughts and emotions in a secure environment with that traumatic event and get free.The skilled therapist also can best help  through a healthy interpersonal relationship ,reflection on time and returning responsibility to the child itself.It is to be mentioned that the content of the child-centered play therapy sessions for each child varies according to internal problems and feelings, and  actually it is a child who has the freedom to direct the play room according to their own internal desires.In order to better implement child-centered play therapy, the play room at the end of the blood section was prepared and equipped by a researcher.Then, according to the predicted schedule, the experimental group sessions were held in 12 sessions of 45 minutes and twice a week, conducted by the researcher. Intervention 2: Control group: During the intervention, the control group did not receive any intervention.</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 I haven't decided.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziye Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrak Ekbatan Faz 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1391936555</zip>
        <telephone>+98 919 227 0399</telephone>
        <email>marziyetalebi66@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sogand Ghasemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Kardan Street, Faculty of Psychology, University of Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445983861</zip>
        <telephone>+98 21 8823 4811</telephone>
        <email>s.ghasemzadeh@ut.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Children 8-12 years old with leukemia cancer undergoing chemotherapy
Inclusion criteria: The interest in collaboration and participation in research is based on the written consent of the legal guardian
Inclusion criteria: Having the power of speech
Inclusion criteria: Not receiving other psychological therapies (except drug therapy)
Inclusion criteria: The relative ability to use hands and part of the general body health to participate play therapy sessions</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria: Existence of severe behavioral disorders and uncontrolled aggression
Exclusion criteria: Missing more than 3 sessions of play therapy sessions
Exclusion criteria: Receive other psychology interventions before or at the same time as conducting the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C95.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Leukemia, unspecified not having achieved remission</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:  Intervention of this research is based on a child-centered play therapy approach and is based on a client-centered  treatment. Play materials(selected on the basis of Landreth  principles) are provided by the therapist to create a safe and free environment for the child, then the child is helped to  rebuild the traumatic event with toys so tha the child revisit and process thoughts and emotions in a secure environment with that traumatic event and get free.The skilled therapist also can best help  through a healthy interpersonal relationship ,reflection on time and returning responsibility to the child itself.It is to be mentioned that the content of the child-centered play therapy sessions for each child varies according to internal problems and feelings, and  actually it is a child who has the freedom to direct the play room according to their own internal desires.In order to better implement child-centered play therapy, the play room at the end of the blood section was prepared and equipped by a researcher.Then, according to the predicted schedule, the experimental group sessions were held in 12 sessions of 45 minutes and twice a week, conducted by the researcher</i_keyword>
      <i_keyword>Control group: During the intervention, the control group did not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resiliency of children with cancer. Timepoint: Resiliency of children with cancer was measured before intervention and a week after the intervention ended. Method of measurement: questionnaire Social Emotional Assets and Resilience Scales(SEARS).</prim_outcome>
      <prim_outcome>Emotion regulation of children with cancer. Timepoint: emotion regulation of children with cancer was measured before intervention and a week after the intervention ended. Method of measurement: Emotion Regulation Questionnaire(ERQ), Emotion Regulation Checklist scoring(ERC).</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>2019-01-13</approval_date>
        <contact_name>Ethics committee of Islamic azad University - Science and Research Branch</contact_name>
        <contact_address>Hesarek daneshgah Boulevard Islamic Azad University, Science and Research Branch Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
