<?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>IRCT20181022041419N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-24</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in Shahid Motahari Educational Centers of Urmia in 2018</public_title>
      <acronym></acronym>
      <scientific_title>The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35412</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hospitalized Children.</hc_freetext>
      <i_freetext>Intervention 1: Robotic training sessions (with the goals specified in each session) will be held for children admitted to mothers in 8 sessions of 1 hour in the evening shifts, during the two weeks of admission to the children's playroom  Motahari Hospital in Urmia,   use of 59 packages which produce from Robofa Iran Co. Affiliated with Sharif University of Technology, named Robot Warrior. Educational information will also be provided in the form of pamphlets and educational CDs. The reason behind the use of this robot, according to a study by the Robotics Institutions, is the ultimate goal of making this robot an incentive to counteract the stresses and problems of children. In order to achieve the objectives of the plan, the 8 steps of the training session will be presented in the form of a structured structure. Intervention 2: Control group: The routine nursing interventions of the children's department will be received.</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:
Only part of the information, such as information on the main outcome or the like, can be shared.

When:
6 months after publish results

To whom:
Researchers working in academia and academia

Conditions:
After permission from the responsible author, any analysis may be possible.

Where to obtain:
simapure@yahoo.com
Sima Pourteioumr
Faculty Member of Urmia Nursing and Midwifery Faculty

How to obtain:
Within a week of sending the email, the documentation will be available with the preservation of spirituality.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Pourteimour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nazlou Campus Building Faculty of Nursing and Midwifery - 11 km Sero - Urmia - West Azarbaijan - Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4963</telephone>
        <email>simapure@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Pourteimour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nazlou Campus Building Faculty of Nursing and Midwifery, 11 km Sero, Urmia, West Azarbaijan,Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4963</telephone>
        <email>simapure@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of mothers over the age of 18 years is to be satisfied with the presence of the research. 
Mother must have hospitalized child. 
The mother is able to communicate in a different language.
The mother has literacy to read and write.
Mothers and children must be native to Orumiyeh city for the purpose of going to the outpatient clinic and performing the intervention and have a readiness and ability to visit one month later to follow up. 
During the time of admission, be sure the mother and the child are present for 60 minutes at the time of the game.
The child has no educational background about the robotic training game. 
The child should have at least one week of hospitalization. 
A child with neurological diseases, such as seizures, mental and mental disabilities, mental problems, and history of taking fluids such as anxiolytics, are not based on a doctor's diagnosis and a child's medical record. Child ages 3 to 7 years.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parental dissatisfaction for participation in the study. 
Missing children participating in more than two sessions of the robotics training program.
Use of drugs that reduce children's anxiety and fear.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Robotic training sessions (with the goals specified in each session) will be held for children admitted to mothers in 8 sessions of 1 hour in the evening shifts, during the two weeks of admission to the children's playroom  Motahari Hospital in Urmia,   use of 59 packages which produce from Robofa Iran Co. Affiliated with Sharif University of Technology, named Robot Warrior. Educational information will also be provided in the form of pamphlets and educational CDs. The reason behind the use of this robot, according to a study by the Robotics Institutions, is the ultimate goal of making this robot an incentive to counteract the stresses and problems of children. In order to achieve the objectives of the plan, the 8 steps of the training session will be presented in the form of a structured structure.</i_keyword>
      <i_keyword>Control group: The routine nursing interventions of the children's department will be received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average score of anxiety of hospitalized children. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: Pre-school children's anxiety questionnaire of 28 items.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Average score of mother-child relationship. Timepoint: Before the intervention, immediately after intervention. Method of measurement: Parent-parent relationship questionnaire of 33 items.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-21</approval_date>
        <contact_name>Urmia university of meducal science</contact_name>
        <contact_address>Kashani Ave., Motahari Hospital, Urmia city Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
