<?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>IRCT2015062814333N37</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>A Comparative study of the effect of Valsalva maneuver and EMLA cream on level of venous cannulation pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness or ineffectiveness of Valsalva maneuver and EMLA cream on level of venous cannulation pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13971</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Randomized by sealed envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>level of venous cannulation pain.</hc_freetext>
      <i_freetext>Intervention 1: The first group made use of EMLA cream, made by Astrazeneca,Eczacibasi Ltd, Turkey. Cream surface is covered by a piece of paper and a 2 cc syringe was used to apply 1 cc, or 2.5 mlg, of the cream on dependent hand where venous cannulation was conducted at 2.5×2.5 cm. after 40 minutes, the dressing was removed from cannulation point and the place was disinfected using cotton drained in alcohol. Then, BP18 IVC was used to do venous cannulation while the patient lay back and his head is against the cannulation point. Also, tourniquet was placed on his forearm. Intervention 2: Valsalva maneuver in the second group was accomplished through blowing in a plastic pipe connected to a mercury barometer (Easylife, china) and holding up mercury bar upper than 20 mmHg for at least 20 seconds. Immediately after that venous cannulation was done similar to the group using EMLA cream. Intervention 3: Both EMLA cream and Valsalva maneuver were applied to the third group. 40 minutes after applying EMLA cream and in similar conditions to the first group, venous cannulation was done immediately after Valsalva maneuver. Intervention 4: All the conditions to the group using EMLA cream were considered to the fourth group. the difference is that Vaseline (Kimiagar-Toos Ltd, Iran) is used in the fourth group instead of EMLA cream. After 40 minutes venous cannulaton was accomplished.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Rostam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, First of Dolatabad Boulvard,Eisar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 9304</telephone>
        <email>KS_ jalali@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: avoiding Systemic analgesics; lack of neurologic defects; lack of respiratory, cardiac, glaucoma diseases; no skin allergy or Atopic dermatitis.&#13;
Exclusion criteria: Intravenous cannula failure in the first attempt.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y60.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>During aspiration, puncture and other catheterization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group made use of EMLA cream, made by Astrazeneca,Eczacibasi Ltd, Turkey. Cream surface is covered by a piece of paper and a 2 cc syringe was used to apply 1 cc, or 2.5 mlg, of the cream on dependent hand where venous cannulation was conducted at 2.5×2.5 cm. after 40 minutes, the dressing was removed from cannulation point and the place was disinfected using cotton drained in alcohol. Then, BP18 IVC was used to do venous cannulation while the patient lay back and his head is against the cannulation point. Also, tourniquet was placed on his forearm.</i_keyword>
      <i_keyword>Valsalva maneuver in the second group was accomplished through blowing in a plastic pipe connected to a mercury barometer (Easylife, china) and holding up mercury bar upper than 20 mmHg for at least 20 seconds. Immediately after that venous cannulation was done similar to the group using EMLA cream.</i_keyword>
      <i_keyword>Both EMLA cream and Valsalva maneuver were applied to the third group. 40 minutes after applying EMLA cream and in similar conditions to the first group, venous cannulation was done immediately after Valsalva maneuver.</i_keyword>
      <i_keyword>All the conditions to the group using EMLA cream were considered to the fourth group. the difference is that Vaseline (Kimiagar-Toos Ltd, Iran) is used in the fourth group instead of EMLA cream. After 40 minutes venous cannulaton was accomplished.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: Immediately after catheter insertion. Method of measurement: Using NRS according to criterion score gained from 0 to 10.</prim_outcome>
      <prim_outcome>Average venous pressure. Timepoint: 5 minutes before venous cannulation and immediately after that. Method of measurement: Using barometer.</prim_outcome>
      <prim_outcome>Heart beat. Timepoint: 5 minutes before venous cannulation and immediately after that. Method of measurement: Using pulse oximeter.</prim_outcome>
      <prim_outcome>Arterial oxygen saturation. Timepoint: 5 minutes before venous cannulation and immediately after that. Method of measurement: Using pulse oximeter.</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>Vice chancellor for research, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-26</approval_date>
        <contact_name>Vice chancellor for research, Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
