<?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>IRCT20150919024080N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-07</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Melissa on stress and hemodynamic parameters</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with Melissa Officinalis essene on Stress and Hemodynamic parameters of patients with acute coronary syndrome at Emergency  unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43430</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who meet the inclusion criteria will be assigned to the two study groups using stratified randomized block design (to match the two groups according to sex and severity of pain). In this way, the first stage of the patient's sex is considered and in different sex the severity of pain in the categories 3-6.9 and 7-10 is considered as the second floor and within the patient classes as 4 or 6 blocks with The use of the computer will be randomly assigned to the two study groups, Blinding description: Melissa Officinalis essence and placebo will be poured into Barry's similar dark glass containers by Barij essence Company and the dishes will be coded by a person who has no role in the study and will be covered by a black bar. The code of the essential oil containers will remain with the research partner until the end of the analysis. The researcher, the statistical consultant, the interventionist, and study participants will be unaware of the contents of the dishes. The therapist will also use a nasal clip for 10 minutes during aromatherapy.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Acute coronary syndrom. Condition 2: Stress. Condition 3: Aromatherapy. Condition 4: Mean atrial pressure and Heart rate.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Melissa officinalis essence 80%, one drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company. Intervention 2: Control group: 2% sunflower oil, two drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Veiskaramian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica</address>
        <city>Khorammabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 916 661 8071</telephone>
        <email>a.veiskaramian67@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica</address>
        <city>Khorammabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 912 509 1279</telephone>
        <email>gholami.m@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of acute coronary syndrome by a specialist based on evidence based electrocardiogram and clinical signs and troponin index
No respiratory disease such as asthma and COPD and allergies or allergies to plants
Entering the emergency department without cardiac arrest
Vigilance and Awareness of place, time and person
No history of head trauma and seizure
No history of confirmed mental illness
No opium and alcohol addiction
No history of PTSD in during the last six months
No history of using other complementary therapies for at least one month before intervention
No disruption of sense of smell
Mean arterial blood pressure more than 90 and heart rate more than 60
Patients with chest pain severity of 3 and more based on visual analogue scale (VAS)
Age over 35 and under 65 years</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients Candidate for primary PCI
Patient's unwillingness to continue participation
Unstable hemodynamic  (20% change compared to time of start intervention)
Incidence of arrhythmias and allergic and respiratory problems during intervention
Transfer patients from the emergency department to the intensive care unit in less than 3 hours
Patient connection to mechanical ventilation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.4</hc_code>
      <hc_code>F43.0</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Melissa officinalis essence 80%, one drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company</i_keyword>
      <i_keyword>Control group: 2% sunflower oil, two drop, two times and 90 minutes away،For 10 minutes at a time، Inhaler with oxygen mask، Adonis Pharmaceutical Company</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in DASS-21 questionnaire. Timepoint: Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy. Method of measurement: DASS-21 Stress Questionnaire.</prim_outcome>
      <prim_outcome>Mean Atrial Pressure. Timepoint: Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy. Method of measurement: Cardiac Monitoring machine.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before intervention, 5 and 15 minutes after the end of aromatherapy on two occasions of aromatherapy. Method of measurement: Cardiac Monitoring machine.</prim_outcome>
      <prim_outcome>Threat perception score. Timepoint: Before and the end of intervention. Method of measurement: Threat Perception Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>قبل از مداخلهpain. Timepoint: Before the intervention, 5 and 15 minutes after the intervention in two aromatherapy treatments. Method of measurement: Visual Analogue Scale.</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>Doesnt have</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-07</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Lorestan, Khorram Abad, 5 Km. Khorram Abad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
