<?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>IRCT20190201042579N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-28</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of EMLA and massage on the pain and anxiety of children</public_title>
      <acronym>EMLA</acronym>
      <scientific_title>Comparison of the effect of EMLA and massage on the pain and anxiety caused by intravenous insertion in hospitalized children of 3-6 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to sampling one of the colleagues was asked to select one of the two sealed envelopes, open it and inform the  content. one of which was written odd days and in another even days. The selected envelope contained even days, and thus the children who were admitted to even days and had inclusion criteria were enrolled in the study.Then the children entered into the study through random selection One of the envelopes with the name of the groups was assigned to one of the four groups of control, massage, spelling, and spelling massage.available sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Children who needed surgery and intravenus line insertion to repair stenosis in the esophagus. Condition 2: Children with inguinal hernia who needed surgery did not have pain during the procedure. Condition 3: Children with inguinal hernia who needed surgery and did not have pain during the procedure. Condition 4: Children who needed intravenus cannula insertion for surgery to remove  Obstruction of gallbladder.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: First intervention group: EMLA cream 1.5 grams of EMLA cream 5%(One gram containing 25 mg of lidocaine and 25 mg of perlocaine) was used, which was done 60 minutes before injection at the injection site using a dressing and after 60 minutes IV insertion was done. Intervention 2: Second Intervention group: Massage in the form of slow motion with a medium pressure of the palms on the skin of the hands and arms and slow-blows of the area of the insertion  that was done from 5 minute before and during the insertion. Intervention 3: Third Intervention group: EMLA cream and massage were used simultaneously as described. Intervention 4: Control group: The intravenous line insertion procedure was performed according to the routine of ward.</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:
Participants' age and weight, gender, scales pain scores, physiological indicators scores and  anxiety scores by groups

When:
Start access from publication of results

To whom:
For researchers, educators, students and health professionals

Conditions:
For further research and for use in the clinic

Where to obtain:
By contacting the author of the email
hanie.neshat@gmail.com

How to obtain:
The applicant can access them after their complete introduction and explanation of the reason for applying and how to use the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Neshat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, shariaty street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174853711</zip>
        <telephone>+98 41 3477 7283</telephone>
        <email>haie.neshat@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Neshat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, shariaty street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174853711</zip>
        <telephone>+98 41 3477 7283</telephone>
        <email>haie.neshat@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 6 to 3 years,
having no pain before the start of venipuncture,
having complete consciousness and physiological stability,
lack of mental retardation
lack of analgesic , sedative, corticosteroid and relaxant medication.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The occurrence of any phenomenon violates the inclusion criteria to the study
Failure to insert the intravenous line with an cannula insertion into the skin and the need for re-effort,</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K22.2</hc_code>
      <hc_code>K40</hc_code>
      <hc_code>K42</hc_code>
      <hc_code>K82.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Esophageal obstruction</hc_keyword>
      <hc_keyword>Inguinal hernia</hc_keyword>
      <hc_keyword>Umbilical hernia</hc_keyword>
      <hc_keyword>Obstruction of gallbladder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: First intervention group: EMLA cream 1.5 grams of EMLA cream 5%(One gram containing 25 mg of lidocaine and 25 mg of perlocaine) was used, which was done 60 minutes before injection at the injection site using a dressing and after 60 minutes IV insertion was done</i_keyword>
      <i_keyword>Second Intervention group: Massage in the form of slow motion with a medium pressure of the palms on the skin of the hands and arms and slow-blows of the area of the insertion  that was done from 5 minute before and during the insertion.</i_keyword>
      <i_keyword>Third Intervention group: EMLA cream and massage were used simultaneously as described.</i_keyword>
      <i_keyword>Control group: The intravenous line insertion procedure was performed according to the routine of ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral changes related to Pain. Timepoint: behavioral changes related to Pain were evaluated Immediately after the cannula insertion of the skin. Method of measurement: behavioral changes related to pain with the wong baker face and FLACC Pain Rating Scale.</prim_outcome>
      <prim_outcome>Changes of the amount of anxiety. Timepoint: Before and After of Intravenus Line Insertion. Method of measurement: visual anxiety scale.</prim_outcome>
      <prim_outcome>Changes  in heart rate related to pain. Timepoint: measurement of heart rate before and immediately after cannula insertion. Method of measurement: heart rate were measured with calibrate pulse oximetry that its model is novametrix.</prim_outcome>
      <prim_outcome>Changes in arterial oxygen saturation percentage related to pain. Timepoint: measurement of arterial oxygen saturation percentage before and immediately after cannula insertion. Method of measurement: arterial oxygen saturation percentage were measured with calibrate pulse oximetry that its model is novametrix.</prim_outcome>
      <prim_outcome>Changes in respiratory rate related to pain. Timepoint: measurement of respiratory rate before and immediately after cannula insertion. Method of measurement: Respiratory rate were measured by counting in a one minute by nurse.</prim_outcome>
      <prim_outcome>Changes  in blood pressure related to pain. Timepoint: measurement of blood pressure before and immediately after cannula insertion. Method of measurement: blood pressure were measured by the calibrate mercury barometer appropriate to the child's arm size (Model: fmt).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-09</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Vice-Chancellor, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
