<?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>IRCT2012111711498N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-04</date_registration>
      <primary_sponsor>Shahed Univer Sity</primary_sponsor>
      <public_title>Lavender Aromatherapy in the Treatment of Anxiety And Dpression</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effectiveness  of Lavender and Almond oil odor aroma therapy On Anxiety and Depression Patients Admitted to the cardiac intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11736</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>ANXEITY AND DEORESION.</hc_freetext>
      <i_freetext>Intervention 1: Groups: first test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for  pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm)   &#13;
Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed.&#13;
 Intervention in the control group will be the same except that instead of a drop of Lavender essential oil is used almond oil odorless. Intervention 2: Groups:placebo test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for  pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm)   &#13;
Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed.</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>Mohammad Reza Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asr intersection of Taleghani - School of Nursing in SHAHED</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>002166418590</zip>
        <telephone>+216 6418590</telephone>
        <email>HEIDARI43@YAHOO.COM</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ABBASE EBADI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>،Tehran, Iran,  Faculty Baghiatollah</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+216 6418587</telephone>
        <email>EBADI432@YAHOO.COM</email>
        <affiliation>The University's OF Baghiatollah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria:Having high anxiety and depression scores of 7 tools HADS,Age over 18 years ,  Patients with a diagnosis of ischemic heart disease, angina and myocardial infarction,No risk of cardiogenic shock, having very poor medical condition, according to doctors at the hospital, Agree attract physicians to enter patients into the study, no pacemaker, no use of complementary therapies (herbal treatments, traditional and other therapies) in a week, no history of psychiatric disorders or being treated for anxiety and depression, lack of drug abuse, no history of asthma, eczema.&#13;
Exclusion criteria included: patient withdrew from the study, grade 3 or 4 heart failure, discharge, or transfer the patient died before the completion of the study, a new stressful situations</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(F00-F99) </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Groups: first test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for  pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm)   &#13;
Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed.&#13;
 Intervention in the control group will be the same except that instead of a drop of Lavender essential oil is used almond oil odorless.</i_keyword>
      <i_keyword>Groups:placebo test: questions HADS (half hour before intervention) starting around 11 am instill 2 drops essential oil of Lavender by interfering emitters connected to a collar on paper and asking the patient to breathe normally for  pin 20 minutes , second measurement: a questionnaire for a second time (an hour later at 12 noon) measured a third time: for a third time to complete the questionnaire (at 8 pm)   &#13;
Continued intervention: at night before bed about 10 pm for another intervention (instill 2 drops Lavender essential oil) is applied to the patient. Fourth assessment: questionnaire for the fourth time in the morning when you wake up (Hdvdsat 7) days after the same has been repeated for patients at the end of the second day and morning of the third day measurements will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the experiment, a time period of 2 days, 9 hours after the intervention. Method of measurement: HADS, Hospital Anxiety and Depression questionnaire.</prim_outcome>
      <prim_outcome>DEPRESSION. Timepoint: Before the experiment, a time period of 2 days, 9 hours after the intervention. Method of measurement: HADS, Hospital Anxiety and Depression questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before the study, an hour later, 9 hours after the study. Method of measurement: Each patient monitoring devices over.</sec_outcome>
      <sec_outcome>PULSE. Timepoint: Before the study, an hour later, 9 hours after the study. Method of measurement: Each patient monitoring devices over.</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>Shahed Univer Sity</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-29</approval_date>
        <contact_name>shahed university</contact_name>
        <contact_address>tehran-around heram emam khomani tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
