<?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>IRCT2017051133808N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-14</date_registration>
      <primary_sponsor>Guilan university Of Medical Sciences</primary_sponsor>
      <public_title>The effect of  aroma therapy on physiological parameters and anxiety in patients with coronary artery diseased</public_title>
      <acronym></acronym>
      <scientific_title>The effect of orange blossom aroma therapy on physiological parameters and anxiety in patients with coronary artery diseased admitted for angiography&#13;
 In2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients with Coronary Artery Disease.</hc_freetext>
      <i_freetext>Intervention 1: For the control group, does not the intervention. Intervention 2: For the control group, does not the intervention. Intervention 3: First, using a standard anxiety questionnaire "Steel standard questionnaire Burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people Will be with simple random sampling in the group will be aromatherapy or without it.&#13;
During aromatherapy for patients, Researchers will try to  accuracy in conducting research on aromatherapy aimed lack of awareness of other patients in the group Without aromatherapy.&#13;
Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety.&#13;
That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room. Intervention 4: First, using a standard anxiety questionnaire "made burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people, simple random sampling in the group will be aromatherapy or without it. Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety. That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room.</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>Parand Pourghane</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gas field in front of Radiator Vice, Chancellor for Research and Technology,  Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 3336 2772</telephone>
        <email>p.pourghane@yahoo.comp.pourghane@gums.ac.ir</email>
        <affiliation>Guilan university Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parand Pourghane</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Council, Guilan, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 3336 2772</telephone>
        <email>p.pourghane@yahoo.comp.pourghane@gums.ac.ir</email>
        <affiliation>Guilan university Of Medical Sciences, Rasht, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The willingness of the patient to participate in the study; patients first underwent coronary angiography placed before angiography; under other methods of invasive Transesophageal echocardiography; not be 6 hours ago nitrate and housing consumption; are not allergies; rhinitis allergic; eczema and respiratory problems have not; before the intervention, no history of headache;  perfume or cologne before or during treatment; not experience stress event acute over the past 6 months; and no history of hospitalization and treatment;  not because of psychological problems. Also, testing positive smell (the ability to detect the smell of aromatherapy desired solution and Pleasure it is the other inclusion criteria.&#13;
Exclusion criteria: having a history of drug addiction According expressed by the patient; as well as having disorders; colds and nasal congestion that affect the sense of smell; the study exclusion criteria will be considered. Also, patients who underwent an emergency angiography are enrolled STEMI patients do not like.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronary thrombosis not resulting in myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For the control group, does not the intervention</i_keyword>
      <i_keyword>For the control group, does not the intervention</i_keyword>
      <i_keyword>First, using a standard anxiety questionnaire "Steel standard questionnaire Burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people Will be with simple random sampling in the group will be aromatherapy or without it.&#13;
During aromatherapy for patients, Researchers will try to  accuracy in conducting research on aromatherapy aimed lack of awareness of other patients in the group Without aromatherapy.&#13;
Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety.&#13;
That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room.</i_keyword>
      <i_keyword>First, using a standard anxiety questionnaire "made burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people, simple random sampling in the group will be aromatherapy or without it. Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety. That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Half an hour before - Half an hour later. Method of measurement: The State-Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Physiological  parameters. Timepoint: Half an hour before and half an hour later. Method of measurement: blood pressure with Sphygmomanometer, Pulse counting with touch of the radial artery, , respiration rate based looking at the numbers going up and down the chest, temperature control based with thermometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Guilan university of Medical Sciences</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_name>Guilan university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-22</approval_date>
        <contact_name>Guilan university Of Medical Sciences</contact_name>
        <contact_address>Gas field, martyr Beheshti Blvd, in front of the West Bank Sepah , on behalf of Radiator Vice Chancellor for Research and Technology, Guilan, Rasht, Iran Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
