<?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>IRCT201309307565N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-11</date_registration>
      <primary_sponsor>AJA University of Medical Sciences</primary_sponsor>
      <public_title>Effect of inhalation aromatherapy on anxiety level of the patients  candidate for Coronary Artery Bypass Graft (CABG)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of inhalation aromatherapy on anxiety level of patients  candidate for Coronary Artery Bypass Graft (CABG)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8061</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group (1): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % Lavender essential oil were poured on the cotton. Then, the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min. Intervention 2: In the experimental group (2): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % orange essential oil were poured on the cotton. Then,  the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min. Intervention 3: In the control group: patients didn’t receive any special intervention and they just smell usual odor of the ward.</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>Nahid Rajai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7750 0404</telephone>
        <email>nahid.rajai@yahoo.com</email>
        <affiliation>AJA Faculty of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Rajai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA Faculty of Nursing, next to the Family hospital, Kaj street, Shariati street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7750 0404</telephone>
        <email>nahid.rajai@yahoo.com</email>
        <affiliation>AJA Faculty of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age of 40 - 80 years old; being literate; without history of mental illnesses, epilepsy, asthma, thyroid and olfactory dysfunction, allergy to the odor of plants specially plants of orange and Lavender, smoking and drug addiction, mechanical ventilation at the time of study; the first experience of surgery of coronary artery bypass graft; willingness to participant in the study. &#13;
Exclusion criteria: refuse to continue corporation in this study.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>151.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group (1): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % Lavender essential oil were poured on the cotton. Then, the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min.</i_keyword>
      <i_keyword>In the experimental group (2): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % orange essential oil were poured on the cotton. Then,  the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min.</i_keyword>
      <i_keyword>In the control group: patients didn’t receive any special intervention and they just smell usual odor of the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: DASS questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: DASS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: Counting the chest movements.</sec_outcome>
      <sec_outcome>Pulse. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: Counting the radial pulse.</sec_outcome>
      <sec_outcome>Depression. Timepoint: The day before surgery, immediately after intervention and 30 min after intervention. Method of measurement: DASS 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>AJA University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-19</approval_date>
        <contact_name>AJA university of Medical Science</contact_name>
        <contact_address>AJA university of Medical Science, next to Emam Reza hospital, Etemadzadeh street, west Fatemi street. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
