<?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>IRCT20171110037347N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-03</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Cartoon Animation and Distraction Card on Reducing the Pain of Children 3-6 Years  Blood sampling and Parental Satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of two methods of distraction with Animation cartoon and distraction cards on pain Perception after Blood sampling and parental satisfaction in children 3-6 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Lottery using blocking
The lottery by blocking is that we have three groups
A = animation cartoon group
B = Band of Deviation cards
C = control group
So we have 6 modes for sample selection: ABC-ACB-BAC-BCA -CAB -CBA
By dropping these dice, it will be determined how the sampling procedure is organized, for example by removing the ACB dice first by intervening in the animation cartoon group, then in the control group, and then in the  distraction card group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Distraction.</hc_freetext>
      <i_freetext>Intervention 1: The executive protocol in the animation cartoon First intervention group is such that after the child He was guided to blood sampling room .The second nurse communicates with the child and then Displayed an animated cartoon Using the tablet 5 minutes before blood sampling It continues until the end of the blood sampling. Blood sampling will be done by the first nurse. Intervention 2: The executive protocol in the distraction cards Second intervention group is such that after the child  guided to blood sampling room .The second nurse communicates with the child and showed the cards to the child(the distraction cards is that distraction cards are cards of dimensions 5 by 8 cm, with various shapes and images, and questions based on the age of the child behind the screen) and told the child that "You can answer my questions if you pay attention to the cards carefully." When the child begins to look carefully at the card, the first nurse starts to take blood and the second nurse begins to ask questions during until end blood sampling, such as "How many babies are you in the picture?" Or " All the boars have a few points? " , "Can you see the filo in your picture?", "How many monkeys do you see in the picture?" etc. Intervention 3: Control group: Blood sampling in the control group will be performed routinely without intervention.</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:
Information on the main outcome

When:
Start the access period one year after the print results

To whom:
Researchers working in academia and academia

Conditions:
By request by valid email

Where to obtain:
Email

How to obtain:
By request, by email and the destination will be available to people

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahimzadeh zeinab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>کد پستی : 13944-9138</zip>
        <telephone>+98 51 3841 3007</telephone>
        <email>Ebrahimzadehz941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahimzadeh zeinab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>کد پستی : 13944-9138</zip>
        <telephone>+98 51 3841 3007</telephone>
        <email>Ebrahimzadehz941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>children 3-6 years
The child has no mental or psychological problem according to the doctor's diagnosis.
The absence of acute and severe pain or the need for urgent emergency procedures, according to the diagnosis of the doctor in charge of treatment.
Presence of a physician's written instruction for blood sampling
Parental presence</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have neuro-developmentally delayed
Have vision and hearing impairment and verbal difficulties
He used analgesic Such as phenobarbital and diazepam 6 hours before blood sampling</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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The executive protocol in the animation cartoon First intervention group is such that after the child He was guided to blood sampling room .The second nurse communicates with the child and then Displayed an animated cartoon Using the tablet 5 minutes before blood sampling It continues until the end of the blood sampling. Blood sampling will be done by the first nurse.</i_keyword>
      <i_keyword>The executive protocol in the distraction cards Second intervention group is such that after the child  guided to blood sampling room .The second nurse communicates with the child and showed the cards to the child(the distraction cards is that distraction cards are cards of dimensions 5 by 8 cm, with various shapes and images, and questions based on the age of the child behind the screen) and told the child that "You can answer my questions if you pay attention to the cards carefully." When the child begins to look carefully at the card, the first nurse starts to take blood and the second nurse begins to ask questions during until end blood sampling, such as "How many babies are you in the picture?" Or " All the boars have a few points? " , "Can you see the filo in your picture?", "How many monkeys do you see in the picture?" etc.</i_keyword>
      <i_keyword>Control group: Blood sampling in the control group will be performed routinely without intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain perception after blood sampling. Timepoint: After Blood sampling and two minutes after Blood sampling. Method of measurement: Wong and Baker pain tool.</prim_outcome>
      <prim_outcome>Parental satisfaction. Timepoint: After blood sampling. Method of measurement: Parental satisfaction 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 University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-12</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad Nursing -Midwifery College,Ibn Sina street, Doctor's Crossroads, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
