<?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>IRCT2015122922682N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-28</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of combined aromatherapy on sleep quality in cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined aromatherapy on sleep quality in hospitalized patients with Acute coronary syndrome (ACS) in cardiac care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Samples based on permutation blocks (four blocks) will be divided into two experimental and control groups. It will be listed according to six possible ways (AABB, ABAB, ...) randomly that will determine the required number of blocks and arrange them into groups based on experimental (B) and control (A).&#13;
For blinding the questionnaire will be completed by a person who is not aware of the research unit in the control group or the experimental group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sleep Quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For three consecutive nights at 09:00 pm, with the supervision of researchers, patients will be exposed to a combination of essential oils of lavender, chamomile and neroli, with 6, 2, 0.5 ratio. A Pharmaceutical company will prepare them in Gorgan. Essential oil will be dropped on a cotton ball, then the Cotton will be hold near the nose of the patients and ask them to close their eyes and take ten deep breaths. After that the cotton will be attached to the collar of the patient by a pin and detached after waking up. The standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after the intervention. Intervention 2: Control group: During the three nights of stay in the ward only routine treatments will be carried out without any intervention by the researchers. The Standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after.</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>Hosein Aalami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Emergency Medicine, Vahdat Blvd.</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 5722 9391</telephone>
        <email>aalami.h@gmu.ac.ir; aalami1358@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Aalami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Emergency Medicine, Vahdat Blvd.</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 5722 9391</telephone>
        <email>aalami.h@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Hospitalized patients with the clinical diagnosis of heart disease in intensive coronary care unit; Having a strong natural tendency for cooperation in doing some medical research and signing the Informed consent form for research; Stable vital signs (blood pressure, pulse, respiration, temperature); Patients' age over 30 and under 80 years; Having no allergic histories to medicines and all herbs (Herbal Medicines or Herbal remedies). &#13;
Exclusion criteria: Patient transfer from the Cardiac Care Unit to the other wards; To be discharged from the hospital either doctor’s order or against medical advice; The patient's unwillingness to continue his or her cooperation in the study; Indication of allergy symptoms.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For three consecutive nights at 09:00 pm, with the supervision of researchers, patients will be exposed to a combination of essential oils of lavender, chamomile and neroli, with 6, 2, 0.5 ratio. A Pharmaceutical company will prepare them in Gorgan. Essential oil will be dropped on a cotton ball, then the Cotton will be hold near the nose of the patients and ask them to close their eyes and take ten deep breaths. After that the cotton will be attached to the collar of the patient by a pin and detached after waking up. The standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after the intervention.</i_keyword>
      <i_keyword>Control group: During the three nights of stay in the ward only routine treatments will be carried out without any intervention by the researchers. The Standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: 2 hours before intervention، 3 days after intervention. Method of measurement: Verran and Snyder-Halpern Sleep Scale (VSH Sleep Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sensitivity to essences. Timepoint: 2 hours before intervention, every 3 hours during intervention and 2 hours after 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, Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-23</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
