<?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>IRCT20210318050739N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-23</date_registration>
      <primary_sponsor>The University of Semnan</primary_sponsor>
      <public_title>The effect of motor games on the development of fundamental motor skills and depression</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  motor games on the development  motor skills and depression in hospitalized children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55125</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sample purposefully selected, And as a simple random selection, Due to the homogeneity of the samples, the lottery method is used. People's names are written on paper and put inside the box. Than the papers are taken out one by one, Until the desired sample, which is about 30 people, is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children with various types of cancer(Leukemia, Lymphoma, Sarcoma, etc.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: َ After pre-testing (Bruininks Oseretsky &amp; Child Depression scale) the intervention group for 8 weeks, tow or three sessions a week, 60 minutes Are affected by the intervention( motor games) from the book, Games for the whole child, Brian Barrett. the after  the intervention (motor games)  so the test will be taken(Bruininks Oseretsky &amp; child Depression scale, Fisher and Lang). Intervention 2: Control group: pre-testing (Bruininks-Oseretsky &amp; Child Depression Scale) is taken. The control group does not undergo any intervention and at the end of the post-test will be taken (Bruininks- Oseretsky &amp; Child Depression Scale).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentifying individuals

When:
From the year 2021

To whom:
All applicants are allowed to access the data

Conditions:
According to the terms and conditions of Semnan University, the data can be used

Where to obtain:
Refer to semnan University. postal code: 3531-19111,  Phone: 00982331530000, Fax: 00982333321005

How to obtain:
From the beginning of November, 2021, After defending the dissertation

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamide Moeini Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.37, 36 Goldast Av, Goldast st, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617634978</zip>
        <telephone>+98 34 3321 5368</telephone>
        <email>Moeinihm4084@gmail.com</email>
        <affiliation>The University of Semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamide Moeini nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.37,Goldasht36, Goldasht st, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617634978</zip>
        <telephone>+98 34 3321 5368</telephone>
        <email>Moeinihm4084@gmail.com</email>
        <affiliation>The University of Semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Evidence of cancer
Age range 3-6 year
Based on a medical record with normal IQ
Same level of motor skills
Homogeneous in terms of height and weight</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have been hospitalized for less than a week
They are not allowed to participate in play therapy sessions
They have a medical ban on sports and games</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: َ After pre-testing (Bruininks Oseretsky &amp; Child Depression scale) the intervention group for 8 weeks, tow or three sessions a week, 60 minutes Are affected by the intervention( motor games) from the book, Games for the whole child, Brian Barrett. the after  the intervention (motor games)  so the test will be taken(Bruininks Oseretsky &amp; child Depression scale, Fisher and Lang)</i_keyword>
      <i_keyword>Control group: pre-testing (Bruininks-Oseretsky &amp; Child Depression Scale) is taken. The control group does not undergo any intervention and at the end of the post-test will be taken (Bruininks- Oseretsky &amp; Child Depression Scale)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score a person gets on the Bruininks- Oseretsky test. Timepoint: Perform pre-test Bruininks- Oseretsky) Before starting the intervention and post-test depending on the length of  hospitalization of children About three months after the pre-test. Method of measurement: Test Bruininks-Oseretsky , purposeful motor games from the game book for the all round development of the child Brian Barrett.</prim_outcome>
      <prim_outcome>Depression score in the Depression Assesment Questionnaire Cds (Fisher Child Depression Scale). Timepoint: Perform pre-test(Fisher and Lang) Before starting the intervention and post-test depending on the length of  hospitalization of children About three months after the pre-test. Method of measurement: Fisher and Lang Children's Depression Test; purposeful motor games from the game book for the all round development of the child Brian Barrett.</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>The University of Semnan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-17</approval_date>
        <contact_name>Ethics commitee of Semnan Uiversity of Medical Scinces</contact_name>
        <contact_address>Semnan University of Medical Sciences, Basij Blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
