<?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>IRCT20170806035528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-21</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences, Vice-Chancellor of Research, Faculty of Nursing and Midwifer</primary_sponsor>
      <public_title>The effect of Painting on fatigue in Children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of painting on fatigue in children with cancer undergoing chemotherapy admitted to Seyedalshohada hospital in Isfahan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26820</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: random allocation (by draw).</study_design>
      <phase>N/A</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before starting the study, completed the questionnaire verbally. Then, the children who were in the intervention group participated in 6 group sessions of open watercolor painting lasting 25 minutes in the painting room. After 25 minut, all children completed their paintings and explained their paintings to the researchers and other children. Immediately after the intervention, the questionnaires were completed again. Intervention 2: control group: Before starting the study, completed the questionnaire verbally. All the provided care in the control group was the same as the intervention group with the difference that the painting sessions were not held in this group, but the children sometimes painted in their rooms. Immediately after the intervention, the questionnaires were completed again.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Tahmasebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord, Shahrekord University of Medical Sciences, Borujen Nursing Faculty</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871948747</zip>
        <telephone>+98 38 3422 6333</telephone>
        <email>zahratahmasebi92@gmail.com</email>
        <affiliation>Shahrekord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Tahmasebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord, Shahrekord University of Medical Sciences, Borujen Nursing Faculty</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871948747</zip>
        <telephone>+98 38 3424 6333</telephone>
        <email>zahratahmasebi92@gmail.com</email>
        <affiliation>Shahrekord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>the age group of 7 to 12 years (due to the ability to paint and respond to the questionnaire)
having one type of cancer
being at least in the third stage of chemotherapy
having the ability to paint and lack of physical and mental retardation
lack of physical problems and anxiety disorders
lack of use of psychotropic drugs or antidepressants.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unwillingness of the children and their families to continue to cooperate, children’s lack of ability to cooperate while studying, absence from 2 or more sessions of paintings, facing acute stress such as divorce of parents, death of parents or siblings, and changing of living location.
children’s lack of ability to cooperate while studying
absence from 2 or more sessions of paintings
facing acute stress such as divorce of parents, death of parents or siblings and changing of living location</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before starting the study, completed the questionnaire verbally. Then, the children who were in the intervention group participated in 6 group sessions of open watercolor painting lasting 25 minutes in the painting room. After 25 minut, all children completed their paintings and explained their paintings to the researchers and other children. Immediately after the intervention, the questionnaires were completed again.</i_keyword>
      <i_keyword>control group: Before starting the study, completed the questionnaire verbally. All the provided care in the control group was the same as the intervention group with the difference that the painting sessions were not held in this group, but the children sometimes painted in their rooms. Immediately after the intervention, the questionnaires were completed again</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before the intervention.after the intervention. Method of measurement: Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale.</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>Isfahan University of Medical Sciences, Vice-Chancellor of Research, Faculty of Nursing and Midwifer</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-16</approval_date>
        <contact_name>Vice chancellor of research and technology, Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan, hezar jarib Street, Isfahan University of Medical Sciences, University headquarters ,Building No. 4, Vice chancellor of research and technology Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
