<?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>IRCT2014041817324N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-15</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman University Of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of EMLA cream with acupressure on  vein puncture pain at 6 -12 year old in teaching hospital's of Rafsanjan University of Medical Science in 2013-2014</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of EMLA cream with acupressure on  vein puncture pain at 6 -12 year old in teaching hospital's of Rafsanjan University of Medical Science in 2013-2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15961</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Intravenous therapy.</hc_freetext>
      <i_freetext>Intervention 1: In this study, there is three groups: the first group of recive EMLA cream, second group acupressure and control group noreceive intervention. Intervention 2: Groups receiving EMLA on the skin: Participants in the group for 45 minutes before venipuncture, EMLA cream on a weight basis (. /1 Kg and 10 cm of body surface area per gram) by the ruler approximately is calculated measures put in place on the vessel is covered with a semipermeable dressing. &#13;
 45 minutes later and cream with cotton gauze removed from the site of pure alcohol and then use the tools to assess and record pain. Intervention 3: Groups receiving Acupressure: Acupressure take two steps within 30 minutes of acupressure group participants do. Movement of the thumb is used to rotate the whole hand and wrist,&#13;
  Finally, the pressure decreases and the quantity of motion is repeated again and the second time than the first time, the intensity of pressure is added.&#13;
  This is 7 times every 20 seconds is repeated for each of the palms of hands immediately after acupressure in palms, yin tang area) or the third eye between the eyebrows (the third eye to be rotated using the thumb and counter-clockwise for 5 minutes is pressed. Intervention 4: The control group did not receive any intervention and routine will be executed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa. Shah Mohammadi Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi seven gardens, pardizeh,  Kerman College Nursing and Midwifery</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717663141</zip>
        <telephone>+98 39 1522 7663</telephone>
        <email>pmohamadi91@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa. Shah Mohammadi Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi seven gardens, pardizeh, Kerman College Nursing and Midwifery</address>
        <city>Kermen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717663141</zip>
        <telephone>+98 39152227663</telephone>
        <email>pmohamadi91@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being aware of the child; The child is not in an emergency situation (there is no urgent need for venipuncture); Venipuncture is the first child; The vessel is taking place in the same group; Lack of sensitivity to lidocaine and Prilocaine (EMLA cream); Absence of any skin disease; Acupressure safe place (lack of scars, burns, cysts and abscesses at the site of acupressure); Full calm children before intervention researcher &#13;
Exclusion criteria: Systemic skin diseases; The appearance of symptoms of allergy to lidocaine Prilocaine (EMLA cream); Taking sedatives or drugs affecting pain before venipuncture; Lower-than-expected vital signs (blood pressure,bradycardia and brady Pnea); Child has physical problems (verbal, mental, visual and auditory), Mental disorders and resist doing acupressure.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, there is three groups: the first group of recive EMLA cream, second group acupressure and control group noreceive intervention.</i_keyword>
      <i_keyword>Groups receiving EMLA on the skin: Participants in the group for 45 minutes before venipuncture, EMLA cream on a weight basis (. /1 Kg and 10 cm of body surface area per gram) by the ruler approximately is calculated measures put in place on the vessel is covered with a semipermeable dressing. &#13;
 45 minutes later and cream with cotton gauze removed from the site of pure alcohol and then use the tools to assess and record pain.</i_keyword>
      <i_keyword>Groups receiving Acupressure: Acupressure take two steps within 30 minutes of acupressure group participants do. Movement of the thumb is used to rotate the whole hand and wrist,&#13;
  Finally, the pressure decreases and the quantity of motion is repeated again and the second time than the first time, the intensity of pressure is added.&#13;
  This is 7 times every 20 seconds is repeated for each of the palms of hands immediately after acupressure in palms, yin tang area) or the third eye between the eyebrows (the third eye to be rotated using the thumb and counter-clockwise for 5 minutes is pressed.</i_keyword>
      <i_keyword>The control group did not receive any intervention and routine will be executed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Immediately after the intervention. Method of measurement: Numerical and behavioral pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Have not. Timepoint: Have not. Method of measurement: Have not.</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>Vice chancellor for research, Kerman University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-19</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Alavi Seven garden, Kerman Razi College of Nursing Midwifery Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
