<?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>IRCT2014102119617N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-17</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of study the effect of aromatherapy with Lavandula oil on pain, anxiety and hemodynamic parameters of patients after coronary artery bypass grafting surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lavender oil aromatherapy associated with pain, anxiety and hemodynamic parameters in patients after coronary artery bypass grafting surgery.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group 5 drops of Lavandula oil 100% will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit. Intervention 2: In the placebo group 5 drops of distilled water will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit.</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>Ezzat Paryad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39841</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>e_paryad@gums.ac.ir; samaneh.ebrahimi8@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ezzat Paryad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-39841</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>e_paryad@gums.ac.ir; samaneh.ebrahimi8@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences, Shahid Beheshti Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: admitted for coronary artery bypass surgery in cardiac surgery ward at Dr. Heshmat Educational and Medical Center in Rasht; patients over 18 years old; without history of drugs affecting on neurological system based on documents; without smell and visual disorders based on commenting of patient; without history of pulmonary diseases, hepatitis, diabetes, chronic headaches, migraines and psychological disorder; without history thyroid diseases (based on documents); without history of cardiac surgery; tendency to collaboration; without history of drugs abuse, smoking and alcohol (based on documents); orientation; without history of allergies, contact dermatitis and sensitivity to plants, especially Lavandula and cosmetic fragrances; without acute diseases; without history of aromatherapy based on documents; bedridden in Intensive Care Unit under 72 hours; duration of intubation in the range of 6 to 8 hours in the Intensive Care Unit based on documents; not to use analgesic, antianxiety drugs, sedative and narcotics during 3 hours before starting of the study and having a systolic blood pressure of 95 mm Hg and upper than.&#13;
Exclusion criteria: any sudden onset of severe changes in vital signs; onset of respiratory allergy signs and having a systolic blood pressure lower than 95 mm Hg at each stage of the research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>139 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group 5 drops of Lavandula oil 100% will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit.</i_keyword>
      <i_keyword>In the placebo group 5 drops of distilled water will rub on the upper lips of patient (the distance between the nose and lips) and would be inhaled in 30 minutes by the patient. Intervention will be done every 24 hours for three consecutive days after discharge from the Intensive Care Unit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and half hour after the intervention every 24 hours for three consecutive days. Method of measurement: Visual Analoge Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and half hour after the intervention every 24 hours for three consecutive days. Method of measurement: Section of anxiety of the Hospital Anxiety and Depression Scale (HADS).</prim_outcome>
      <prim_outcome>Diastolic and systolic blood pressure. Timepoint: Before the intervention and half hour after the intervention every 24 hours for three consecutive days. Method of measurement: By using a mercury sphygmomanometer based on mmHg.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: Before the intervention and half hour after the intervention every 24 hours for three consecutive days. Method of measurement: Based on the number of pulses in a minute.</prim_outcome>
      <prim_outcome>Respiration. Timepoint: Before the intervention and half hour after the intervention every 24 hours for three consecutive days. Method of measurement: Based on the number of breaths in a minute.</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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-17</approval_date>
        <contact_name>The ethics committee of assistance of research of Guilan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Nursing and Midwifery Faculty, Guilan University of Medical Sciences, Highway of Shahid Beheshti, Student Avenue Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
