<?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>IRCT20201209049662N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of aromatherapy situational anxiety and physiologic indexes of patients after coronary angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of aromatherapy with Geranium Essence and Lemon on situational anxiety and physiologic indexes of patients after coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53014</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, no patient will be aware of their group and a random sequence will be performed, and the method of using randomly coded boxes will be used. In this method, a number of boxes selected by the researcher as the first group and the same number of boxes for the next groups are considered; Then, by merging the boxes together, a box is taken out and its allocation is recorded, and that box is returned to the other boxes after being taken out. The boxes are then reassembled and another box is removed. This process continues until a random sequence according to the sample size is reached. Thus, patients will be divided into three groups: geranium essential oil (group 1), lemon essential oil (group 2) and control group (sweet almond oil - group 3), Blinding description: Essential oil and control bottles will be covered with black tape and its type is unknown to healthcare providers and patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Geranium Essence. The geranium essential oil used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains alphapinene (1.35%), citronellol (37.53%), geraniol (7.2%). And citronel formate (10.03%). To perform the intervention, the researcher pours three drops of geranium essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured. Intervention 2: Intervention group2: Lemon Essence. The essential oil of lemon used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains limonene (51.75%), betapinene (6.83%), terpinoline (5.16%). And alphapinene (2.45%). To perform the intervention, the researcher pours three drops of lemon essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured. Intervention 3: Control group: Sweet almond oil. To perform the intervention, the researcher pours three drops of sweet almond oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and the physiological parameters are measured. The control group did not receive any intervention and is cared for according to the usual care of the ward.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Asadi Mobarakeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.45, Aria Building, Shahid Zahraei Alley, Artesh street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۵۵۱۳۹۹۹۸</zip>
        <telephone>+98 31 3620 0409</telephone>
        <email>maryamasadii@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Asadi Mobarakeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.45, Aria Building, Shahid Zahraei Alley, Artesh street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۵۵۱۳۹۹۹۸</zip>
        <telephone>+98 31 3620 0409</telephone>
        <email>maryamasadii@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Ability and willingness to complete the questionnaire
Have not undergone other invasive procedures such as esophageal echocardiography before angioplasty.
Everyone is fully conscious and not in a critical condition</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use painkillers or anti-anxiety medications before the study
Existence of hearing, olfactory and mental problems
Existence of acute and chronic mental illnesses
History of allergy to the geranium plant or extract and lemon fruit or extract
Postoperative complications (severe pain, active bleeding or infection)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z98.61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronary angioplasty status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Geranium Essence. The geranium essential oil used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains alphapinene (1.35%), citronellol (37.53%), geraniol (7.2%). And citronel formate (10.03%). To perform the intervention, the researcher pours three drops of geranium essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured.</i_keyword>
      <i_keyword>Intervention group2: Lemon Essence. The essential oil of lemon used in this study was prepared by Tabib Daroo Company and according to the essential oil analysis sheet prepared by Tabib Daroo Company, this essential oil contains limonene (51.75%), betapinene (6.83%), terpinoline (5.16%). And alphapinene (2.45%). To perform the intervention, the researcher pours three drops of lemon essential oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and physiological parameters are measured.</i_keyword>
      <i_keyword>Control group: Sweet almond oil. To perform the intervention, the researcher pours three drops of sweet almond oil on a cloth and attaches it to the shirts of the subjects in the target groups, so that patients can inhale the perfume for 20 minutes. After 20 minutes, the situational anxiety questionnaire is completed again by the samples and the physiological parameters are measured. The control group did not receive any intervention and is cared for according to the usual care of the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Situational Anxiety. Timepoint: Before and 20 minutes after the intervention. Method of measurement: Spielberger Standard Situational Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Physiological indicators. Timepoint: Before and 20 minutes after the intervention. Method of measurement: Checklist of physiological parameters of patients including systolic and diastolic blood pressure, respiratory rate, pulse rate and arterial oxygen saturation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-18</approval_date>
        <contact_name>Ethics committee of Islamic Azad University - Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>University Blvd, Arqavanieh, East Jey street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
