<?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>IRCT20221005056090N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-22</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of olive oil consumption on surgical outcomes in open heart surgery patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of olive oil consumption on surgical outcomes in open heart surgery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Randomization description: Sampling method was a block random sampling method. Equal numbers were placed in two groups of test and control. First, 4 blocks were formed by choosing the letter A for the intervention group and choosing the letter B for the control group, such as (-ABBA-ABAB-BABA-BAAB-BBAA- AABB), and a total of six blocks were written on six separate sheets of paper. And it was placed in a container. Then one of the blocks was randomly selected and the first four were selected. This block was again included in the set of blocks and another block was randomly selected for the second time, and in the same way, all the participants were selected according to their entry into the study. People in the test group will be placed in the test group based on having the conditions to enter the study and their satisfaction and ability, Blinding description: In this research, in order to prevent the analyst from applying the taste of the participating groups to two groups A and B without mentioning the intervention and the witness, the data was entered into the spss software and the analyst was not aware of the allocation of people to the groups in all stages of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who were admitted to the hospital for open heart surgery were candidates to enter the study as a sample. From the night of hospitalization, according to the type of diet, the investigated parameters and the patient's conditions, the amount of 30 cc of extra virgin olive oil from Rudbar North of Iran will be added to the patient's diet at lunch and dinner (15 cc each meal) on a daily basis. Hospitalization for surgery is done for one month. Intervention 2: Control group:  patients do not receive any amount of olive oil.</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 At the discretion of the professors, the results will be published</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Abbas Ebadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing</address>
        <city>trhran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4573135747</zip>
        <telephone>+98 21 8755 0001</telephone>
        <email>ebadi1347@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maleeha Sadat Moid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahai Street, Baqiyatullah University, Faculty of Nursing</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4573135747</zip>
        <telephone>+98 21 8755 0001</telephone>
        <email>msmoayed@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-emergency heart surgery
No history of significant digestive problems</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with surgery other than cabg</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who were admitted to the hospital for open heart surgery were candidates to enter the study as a sample. From the night of hospitalization, according to the type of diet, the investigated parameters and the patient's conditions, the amount of 30 cc of extra virgin olive oil from Rudbar North of Iran will be added to the patient's diet at lunch and dinner (15 cc each meal) on a daily basis. Hospitalization for surgery is done for one month</i_keyword>
      <i_keyword>Control group:  patients do not receive any amount of olive oil</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining the effect of olive oil consumption on the incidence of pleural effusion in patients after open heart surgery. Timepoint: The first day before surgery،The day after the operation،The second week after the operation. Method of measurement: chest x-ray.</prim_outcome>
      <prim_outcome>Determining the effect of olive oil consumption on constipation in patients after open heart surgery. Timepoint: The day before the operation،Length of hospitalization،After discharge, twice a week until one month from the time of hospitalization. Method of measurement: Bristol scale.</prim_outcome>
      <prim_outcome>Determining the effect of olive oil consumed by patients on readmission of patients after open heart surgery after consuming olive oil. Timepoint: One month from the time of hospitalization in case of patient referral. Method of measurement: Hospital admission.</prim_outcome>
      <prim_outcome>Determining the effect of olive oil on reducing the pain of open heart surgery in ICU OH patients. Timepoint: The day before the operation،Length of hospitalization،After discharge, twice a week until one month from the time of hospitalization. Method of measurement: vas scale.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-25</approval_date>
        <contact_name>Ethics Committee of Baqiyatullah University of Medical Sciences</contact_name>
        <contact_address>No. 8, Padgan Street, ally Entezari قزوین Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
