<?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>IRCT2013121415789N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-08</date_registration>
      <primary_sponsor>Vice chancellor for research, Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effects of aroma " Citrus aurantium L."  on sleep quality in heart patients</public_title>
      <acronym></acronym>
      <scientific_title>The effects of inhalator aromatherapy with Citrus Aurantium L. essence versus placebo on the sleep quality in heart patients: a single blinded randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14947</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: in start of sampling, two blue and red balls (Called the Control and intervention balls come into use randomly selected from each of the cardiac care units (the two wards) just for the sake of sampling, and some alterations are being made to the sampling place alternatively every week until the size of the samples has reached 30.&#13;
How to blind?&#13;
No one knows in what groups they will be placed.</study_design>
      <phase>1</phase>
      <hc_freetext>Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aroma "Citrus aurantium" was prepared by Research Institute of Forests and Rangelands, Tehran, and diluted with sun flower oil to 10 percent of dilution. For three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three  deep breathes  by patient.  SMHSQ before and after will be completed. Intervention 2: Control group: Pure sun flower oil, for three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three deep breath by patient. SMHSQ before and after will be completed.</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>Fariba Mohamadi Hariry</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Science, Shahid Bahonar Blvd. Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 1333 6001</telephone>
        <email>aseman_f_hariry@yahoo ; aghoudosi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Mohamadi Hariry</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Science, Shahid Bahonar Blvd.Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 282813338034</telephone>
        <email>aseman_f_hariry@yahoo ; aghoudosi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Hospitalized patients with the Clinical diagnosis of heart disease in intensive coronary care unit.&#13;
Having a strong natural tendency for cooperation in doing some medical research and signing the Informed Consent form for research.&#13;
Stable vital signs ((blood pressure, pulse, respiration, temperature)  &#13;
Patients aged over 18 and under 65. &#13;
Patients with no medical histories of mental illness having led to a long period hospitalization and the consumption of psychiatric drugs.&#13;
No use of herbal medicines in the past two weeks.&#13;
Having no allergic histories to medicines and all herbs (Herbal Medicines or Herbal remedies) &#13;
No allergy symptoms were caused about all the medicines they had taken in the allergy tests.&#13;
Positive indicators of Epworth Questionnaire (score&gt;5)&#13;
To have taken “Berlin questionnaire for sleep apnea” to be positive.&#13;
Exclusion Criteria:&#13;
Vital sign instability which leads to a change in drug instructions.&#13;
Dosage change and the sedative drugs deletion, if desired.&#13;
The transference of patients from the Cardiac Care Unit to the other wards.&#13;
To be discharged from the hospital –doctor’s orders or against medical advice.&#13;
To display no tendencies to cooperate on the research any longer.&#13;
Allergy symptoms are to be caused.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>120-121-12</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischemic Heart Disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aroma "Citrus aurantium" was prepared by Research Institute of Forests and Rangelands, Tehran, and diluted with sun flower oil to 10 percent of dilution. For three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three  deep breathes  by patient.  SMHSQ before and after will be completed.</i_keyword>
      <i_keyword>Control group: Pure sun flower oil, for three consecutive nights using the inhalation, every night is poured three drops on a tissue and inhale three deep breath by patient. SMHSQ before and after will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: 2 hours preintervention - 3 days post intervention. Method of measurement: St Marry's Hospital Sleep Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sensitivity to Citrus Aurantium L. essence. Timepoint: 2 hours preintervention- every 3 hours during intervention and 2 hours  post intervention. Method of measurement: Clinical signs and symptoms.</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>Vice chancellor for research, Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-15</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
