<?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>IRCT20170924036366N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-04</date_registration>
      <primary_sponsor>Deputy of Research of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Design and evaluation of an educational Serious Game to control emotional skills</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating a serious educational game to improve controlling emotional skills of members at Center of Children and Adolescents Intellectual Development of Mashhad</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>27</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization will be used. A numeric code will be assigned to each case. Then these numbers will be attached to randomization.com and after conducting randomization process and assigning numbers into two groups, cases will be randomly assigned to groups including intervention group and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Emotional skills.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Electronic learning intervention will be done through a serious game. In addition to the routine training, a serious game will be used for training. The game will be developed in a single user environment for android OS to be installed on a tablet in order to help the trainer to do the intervention easily. The game will be design based on the book entitled "Rabbit Feelings" by Trace Moroney. This book is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9. The child would consider himself/herself as a third person in the game and the training would be done entirely interactive so that a suitable feedback would be given to him/her for every action. The most important advantages of using this approach to train children are being interactive, repetitive and giving feedback. Intervention period will be one month. Intervention 2: Control group: The children in the control group will just receive routine training based on the book entitled "Rabbit Feelings" by Trace Moroney which is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9.. In this approach, the trainer once read the book for the children and try to explain them all mentioned emotions and how to control those emotions orally.</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:
The data will all be anonymous and encrypted. So, all the data will be shared.

When:
Once the results are published indefinitely, unlimited access will be possible.

To whom:
There is no limitation.

Conditions:
There is no limitation.

Where to obtain:
We pledge to respond by tabatabaeimh@mums.ac.ir

How to obtain:
We pledge to respond within one business day by tabatabaeimh@mums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Sharifzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Medical Informatics - Faculty of Medicine of Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1394491388</zip>
        <telephone>+98 51 3882 7049</telephone>
        <email>nd.sharifzadeh@gmail.com</email>
        <affiliation>Faculty of Medicine of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Mohammad Tabatabaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Medical Informatics, Faculty of Medicine of Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1394491388</zip>
        <telephone>+98 51 3882 7049</telephone>
        <email>tabatabaeimh@mums.ac.ir</email>
        <affiliation>Faculty of Medicine of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Membership in Center of Children and Adolescents Intellectual Development of Mashhad
Parental consent</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dealing with mental disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>z73</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to life management difficulty</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Electronic learning intervention will be done through a serious game. In addition to the routine training, a serious game will be used for training. The game will be developed in a single user environment for android OS to be installed on a tablet in order to help the trainer to do the intervention easily. The game will be design based on the book entitled "Rabbit Feelings" by Trace Moroney. This book is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9. The child would consider himself/herself as a third person in the game and the training would be done entirely interactive so that a suitable feedback would be given to him/her for every action. The most important advantages of using this approach to train children are being interactive, repetitive and giving feedback. Intervention period will be one month.</i_keyword>
      <i_keyword>Control group: The children in the control group will just receive routine training based on the book entitled "Rabbit Feelings" by Trace Moroney which is used to train controlling emotional skills including fear, anger, happiness, sadness for children with the age group of 7-9.. In this approach, the trainer once read the book for the children and try to explain them all mentioned emotions and how to control those emotions orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional skills (including fear, anger, happiness, sadness). Timepoint: Before the intervention and two months after the end of the intervention. Method of measurement: emotional skills questionnaire.</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>Deputy of Research of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-06</approval_date>
        <contact_name>Deputy of Research of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
