<?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>IRCT20170624034723N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-05</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>The effect of nursing interventions based on Wells scale results in the incidence of deep vein thrombosis</public_title>
      <acronym>DVT</acronym>
      <scientific_title>The effect of nursing interventions based on Wells scale results on the incidence of deep vein thrombosis in patients admitted to the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26462</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Participants were randomly assigned and randomly divided into two intervention groups (36) and a control group (36) using a randomized design designed by a statistic consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Deep Vein Thrombosis.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, patients who are on a Wells scale fall into an unprotected group. Nursing interventions include exercise (flexion and dorsiliation of the lower limb flexion), respiratory exercises, effective cough, and maintaining lower limbs above the cardiac level. Patients who are considered to be at high risk of developing deep vein thrombosis based on the Wells scale, in addition to nursing interventions, will use mechanical preventive measures (anti-embolic socks) and drug prevention (Enoxaparin Sodium based on the prescribing dose of the physician). Intervention 2: In the control group (n = 36) after the classification of patients according to Wells scale to two levels of no-risk (18 cases) and at high risk (18 cases), deep vein thrombosis involved patients with routine care interventions including: exercise ( Respiratory exercises, effective cough, and lower extremity maintenance are higher than the heart rate, according to the instructions of the respective physician.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morteza Habibi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15749</zip>
        <telephone>+98 61 3373 8396</telephone>
        <email>habibi.morteza94@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Asadizaker</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15749</zip>
        <telephone>+98 61 3373 8396</telephone>
        <email>marziyehasadizaker@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age range is 18 to 65 years
Patients with a minimum shelf-life of 10 days in Intensive Unit</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Deep Vein Thrombosis or pulmonary embolism.
take drugs that lead to blood coagulation, such as Tranexamic Acid.
chronic disease that affects the treatment process, such as severe vascular disease, kidney failure.
having chronic alcohol consumption history
Pregnancy.
In the event of any hemodynamic disorder (such as severe rhythm instability, septic shock and instability in blood pressure).
Patients with coronary artery disease in the acute phase.
Detect an imminent death by a doctor.
Failure to co-operate with the patient or his supervisor.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Formation of thrombosis in the deep veins</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, patients who are on a Wells scale fall into an unprotected group. Nursing interventions include exercise (flexion and dorsiliation of the lower limb flexion), respiratory exercises, effective cough, and maintaining lower limbs above the cardiac level. Patients who are considered to be at high risk of developing deep vein thrombosis based on the Wells scale, in addition to nursing interventions, will use mechanical preventive measures (anti-embolic socks) and drug prevention (Enoxaparin Sodium based on the prescribing dose of the physician).</i_keyword>
      <i_keyword>In the control group (n = 36) after the classification of patients according to Wells scale to two levels of no-risk (18 cases) and at high risk (18 cases), deep vein thrombosis involved patients with routine care interventions including: exercise ( Respiratory exercises, effective cough, and lower extremity maintenance are higher than the heart rate, according to the instructions of the respective physician.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of deep vein thrombosis. Timepoint: Days 1, 5, 10. Method of measurement: Wells scale, d-dimer, Doppler ultrasound.</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, Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-23</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
