<?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>IRCT20180428039451N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-20</date_registration>
      <primary_sponsor>Mashhad Ferdowsi University</primary_sponsor>
      <public_title>Investigating the effect of landscape and planting design in improving children’s neuropsychological health in hospital environments</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of landscape and planting design in improving children’s neuropsychological health in hospital environments</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31048</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This research is a simple random method in which by inserting numbers on the paper, the rooms and beds belonging to the control group and the test group are randomly identified by the head nursing team. In the second step, the patient's children who come to the hospital take the paper containing their bed number and room number from inside a dish in which their bed and room number is inserted. The paper also states that the patient's bed and room are in the control group or the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The neuropsychological health.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: includes the children admitted and hospitalized in Akbar Children's Super Specialty Hospital. In the first step, the opinions, needs and preferences of the user group (sick children) are evaluated using a questionnaire survey. Designing the questionnaire and the method of survey is adapted from Todorova et al.(2004). The method will be such that photomontages will first be provided as flash cards to the patient's child and the patients will be guided by the surveyor to complete his or her questionnaire based on the photos. In this research, photographs will be printed and provided to the respondent group (sick children). Intervention 2: The second intervention group: In the second step, in order to assess the preferences about the landscape of the hospital space and its impact on sick children based on the experts’ idea, a questionnaire will be adapted from Petros and Georgi (2011). This questionnaire will be available to the experts and will be carefully filled in by them. Intervention 3: The third intervention group: In the third step, the visual effect of green spaces on physical and neuropsychological improvement of two groups of sick children (group A:(experimental group) sick children in a room with natural plants and scenes that are not harmful to the patients; and group B: (control group) patient children in a room without natural plants will be assessed and compared in Akbar Children's Super Specialty Hospital. The method of the work will be to fill physical and neuropsychological state of the child by recording their physical factors which are approved by a specialist team, and then a questionnaire that has been approved by several specialists, will be filled at the admission time to the hospital. The same questionnaire will be filled by the patient children once the patient has been discharged from the hospital. The patient's physical factors will also be re-recorded when the patient is discharged from the hospital.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Allahyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۱۷۷۹۴۸۹۷۴</zip>
        <telephone>+98 51 3880 5000</telephone>
        <email>allahyar.maryam9@gmail.com</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Agriculture, Ferdowsi University of Mashhad, University of Pardis, Azadi Square, Mashhad, Khorasan Razavi, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۱۷۷۹۴۸۹۷۴</zip>
        <telephone>+98 51 3880 5000</telephone>
        <email>fatemeh.kazemi@um.ac.ir</email>
        <affiliation>Mashhad Ferdowsi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major conditions for entering into the first phase of the study based on Questionnaire No. 1:
All sick children should have an age ranged from 6 to 15 years old in Akbar Children's Super Specialty Hospital.
They must not be categorized in exceptional groups of children such as those with Intelligence Development Disabilities (IDD), and the Autism spectrum Children's Group and the group of children with anxiety and attention deficit disorders.
The parents of these children, must have the following characteristics:
1. Only the parents of the children with an age ranged from 6 to 15 years old will participate in the first questionnaire survey.
2. These parents must have completed at least grade 1 of the primary educational levels.
Major conditions for entering into the second phase of the study based on Questionnaire No. 2:
Only doctors, nurses and personnels who work in the workforce of Akbar Children's Super Specialty Hospital are included.
Major conditions for entering into the third phase of the study based on Questionnaire No. 3:
All parents of the children hospitalized in Akbar Children's Super Specialty Hospital are permitted to participate in this survey providing that:
1. Their child is in age range of 6 to 15 year.
2. They have completed at least grade 1 of the primary educational levels.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Major non-entry conditions include parents with an income less than $ 2 million tomans.
Those who are dependent to psychiatric and narcotic medicines.</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: includes the children admitted and hospitalized in Akbar Children's Super Specialty Hospital. In the first step, the opinions, needs and preferences of the user group (sick children) are evaluated using a questionnaire survey. Designing the questionnaire and the method of survey is adapted from Todorova et al.(2004). The method will be such that photomontages will first be provided as flash cards to the patient's child and the patients will be guided by the surveyor to complete his or her questionnaire based on the photos. In this research, photographs will be printed and provided to the respondent group (sick children).</i_keyword>
      <i_keyword>The second intervention group: In the second step, in order to assess the preferences about the landscape of the hospital space and its impact on sick children based on the experts’ idea, a questionnaire will be adapted from Petros and Georgi (2011). This questionnaire will be available to the experts and will be carefully filled in by them.</i_keyword>
      <i_keyword>The third intervention group: In the third step, the visual effect of green spaces on physical and neuropsychological improvement of two groups of sick children (group A:(experimental group) sick children in a room with natural plants and scenes that are not harmful to the patients; and group B: (control group) patient children in a room without natural plants will be assessed and compared in Akbar Children's Super Specialty Hospital. The method of the work will be to fill physical and neuropsychological state of the child by recording their physical factors which are approved by a specialist team, and then a questionnaire that has been approved by several specialists, will be filled at the admission time to the hospital. The same questionnaire will be filled by the patient children once the patient has been discharged from the hospital. The patient's physical factors will also be re-recorded when the patient is discharged from the hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The neuropsychological  health. Timepoint: For the third questionnaire, the measurements will be done first at the time of entering into the hospital, then at the time of discharge from the hospital and in fact after being hospitalized in the expected rooms. (It's worth noting that investigations in questionnaires 1 and 2 do not have limited measure periods). Method of measurement: 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>Mashhad Ferdowsi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-03</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Iran, Khorasan Razavi, Mashhad, University Street, Quraishi Building, Head of Department of Khorasan Razavi University of Medical Sciences and Health Services Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
