<?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>IRCT2014040917197N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-23</date_registration>
      <primary_sponsor>Tehran Universiy of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of local cold and warmth upon the size of bruising at the injection site of subcutaneous Enoxaparin.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of local cold and warmth upon the size of bruising at the injection site of subcutaneous Enoxaparin.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15871</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diseases of skin and subcutaneouse tissue.</hc_freetext>
      <i_freetext>Intervention 1: In the group 1: cold compress are exerted on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes, using a towel,  just after every injection in abdomen. Intervention 2: In the group 2: in addition to exertion of cold compress on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes just after every injection in abdomen, over 12 hours of injection time, warm compress bag will be placed as well on the same point of injection, using a towel, for 20 minutes. Intervention 3: Third group is called control group and dose not take any special action to these patients except routine injection of subcutaneous Enoxaparin.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.tandfonline.com/doi/abs/10.1080/10376178.2016.1190289</results_url_link>
      <results_summary>   Purpose: This study aimed to assess the effect of the application of local cold and cold-hot packs upon the size of bruising at the injection site of subcutaneous Enoxaparin sodium. &lt;br /&gt;&#13;
Methods: One-hundred and eighty patients with coronary diseases were allocated randomly to three groups: (i) local cold gel pack group; (ii) local cold-hot gel pack group; and (iii) control group. Assessment of the presence of a bruise was conducted at 24, 48 and 72 hours after the injections for all patients. &lt;br /&gt;&#13;
Results: The cold-hot pack group had significantly less and smaller injection site bruising than the two other groups at 48 and 72 hours (both p &lt; 0.001). &lt;br /&gt;&#13;
Conclusions: The local application of cold-hot packs is more effective on reducing bruises following enoxaparin sodium injections when compared with local cold pack application alone. Thus, this process can improve the quality of nursing care for hospitalized patients receiving these injections.&lt;br /&gt;&#13;
Keywords:  low-molecular-weight heparin; enoxaparin; injections; bruising; cold application&lt;br /&gt;&#13;
        </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>Shokooh Varaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4327</telephone>
        <email>shvaraei@tums.ac.ir</email>
        <affiliation>The faculty of Nursing and Midwifery of Tehran University of Medical Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient do not be pregnant; has not any coagulation disorders; the patient has the written order for injection Enoxaparin 60mg by doctor per 12 hours; and there is not record of previous injections during last 24hours in his/her abdominal area. &#13;
Exclusion criteria: The drug of Enoxaparin stopped by doctor or changed; there is bleeding in injection area.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XII</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>L00-L99</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the group 1: cold compress are exerted on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes, using a towel,  just after every injection in abdomen.</i_keyword>
      <i_keyword>In the group 2: in addition to exertion of cold compress on the injection site of 60 patients under treatment by subcutaneous Enoxaparin (60 mg), for 20 minutes just after every injection in abdomen, over 12 hours of injection time, warm compress bag will be placed as well on the same point of injection, using a towel, for 20 minutes.</i_keyword>
      <i_keyword>Third group is called control group and dose not take any special action to these patients except routine injection of subcutaneous Enoxaparin.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The size of bruising at the injection site of subcutaneous Enoxaparin. Timepoint: Until 3 days after the injection. Method of measurement: Using a plastic ruler.</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>Tehran Universiy of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-02-03</approval_date>
        <contact_name>Tehran university of Medical Sciences</contact_name>
        <contact_address>The Central Building of Tehran university of Medical Scienc, keshavarz Street, Qods Street, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
