<?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>IRCT2013111014634N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effect of topical Olive oil on prevention of bedsore in intensive care unit patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of topical Olive oil on prevention of bedsore in ICU patients at educational -medical hospitals of Qazvin .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Bedsore.</hc_freetext>
      <i_freetext>Intervention 1: The control group is received skin care&#13;
includes changing position every 2 hours and floating mattress (the standard treatment that in all centers are only included this). Intervention 2: The intervention group in addition to changing positions every 2 hours and floating mattress (standard therapy), receive topical Olive oil. Famila labeled virgin Olive oil with Standard sign has been prepared, which once a day and each time 15 cc of it is gently and without massage applied on Pinna, Shoulders, Spine, Waist, Buttocks, Iliacs and Sacrum, Elbows, Heels and Ankles areas. Selected patients receive topical Olive oil for three weeks and every 24 hours the skin care area is observed and evaluated by the investigator and occurrence or non-occurrence of bedsores grade 1-4 in these areas is recorded in questionnaire.It also is stipulated that the two groups do not use any creams or other oil on the area. Meanwhile, the two groups is matched by age and sex.</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>Zahra Abbas Ali Madadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 1367 6284</telephone>
        <email>madadi_z20@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Reza Zeighami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 1333 8127</telephone>
        <email>behsare@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major inclusion criteria: having 18-90 years old; lack of skin problems;&#13;
lack of bedsores; no history of diabetes; no history of sensitivity to the Olive and Olive products; having a Foley catheter.&#13;
Major exclusion criteria: the incidence of any sensitivity due to using of Olive oil; lack of consent of guardians and sample to continue to participate in the study; transferring  the patient to another center outside the city of Qazvin; the patient dies; observing any Sign of skin problems (rash, hives, redness, swelling, ulcers).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Decubitus ulcer and pressure area</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group is received skin care&#13;
includes changing position every 2 hours and floating mattress (the standard treatment that in all centers are only included this).</i_keyword>
      <i_keyword>The intervention group in addition to changing positions every 2 hours and floating mattress (standard therapy), receive topical Olive oil. Famila labeled virgin Olive oil with Standard sign has been prepared, which once a day and each time 15 cc of it is gently and without massage applied on Pinna, Shoulders, Spine, Waist, Buttocks, Iliacs and Sacrum, Elbows, Heels and Ankles areas. Selected patients receive topical Olive oil for three weeks and every 24 hours the skin care area is observed and evaluated by the investigator and occurrence or non-occurrence of bedsores grade 1-4 in these areas is recorded in questionnaire.It also is stipulated that the two groups do not use any creams or other oil on the area. Meanwhile, the two groups is matched by age and sex.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bedsore. Timepoint: Once every 24 hours. Method of measurement: Skin areas is observed and evaluated by the investigator and the occurrence or non-occurrence of bedsores  grade 1-4  in these areas is recorded in questionnaire.</prim_outcome>
      <prim_outcome>Applying topical Olive oil. Timepoint: Once every 24 hours. Method of measurement: Based on yes or no is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Duration of lack of developing bedsore. Timepoint: Once every 24 hours. Method of measurement: Based on day is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Age. Timepoint: First meeting of evaluation. Method of measurement: Based on year is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Sex. Timepoint: First meeting of evaluation. Method of measurement: Based on sex  is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Weight. Timepoint: First meeting of evaluation. Method of measurement: Based on Kilogram is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Amount of mobility. Timepoint: Once every 24 hours. Method of measurement: Based on  Braden scale is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Defecation control. Timepoint: Once every 24 hours. Method of measurement: Based on yes or no is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Position of head of bed. Timepoint: Once every 24 hours. Method of measurement: Based on degree is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Height. Timepoint: Once every 24 hours. Method of measurement: Based on Meter and Centimeter  is recorded in the questionnaire.</prim_outcome>
      <prim_outcome>Taking Carbamazepine, Co-trimoxazole and Largactil. Timepoint: Once every 24 hours. Method of measurement: Based on yes or no is recorded in the questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of ICU hospitalization. Timepoint: Once at the end of ICU hospitalization. Method of measurement: Based on day is recorded in the questionnaire.</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, Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-05</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
