<?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>IRCT20111210008348N45</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-06</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with lemon essential oils on nausea, vomiting and anxiety in patients undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with lemon essential oils on nausea, vomiting and anxiety in patients undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using on an line randomizer tool (https://www.randomizer.org).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Nausea and vomiting. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours a drop of sour lemon essential oil onto a paper towel with a drip during chemotherapy and attaches it to the collar of the research unit with a pin, then asks him to breathe normally. This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed. Intervention 2: Control group: In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours  3 ml of water (placebo) poured on the paper and the collar is connected sick during chemotherapy.This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Data of participants are confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morteza Moghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Khordad Blvd., Alley 54, Alley 12, No. 8</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3714834141</zip>
        <telephone>+98 25 3722 3661</telephone>
        <email>mortezamoghari@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Moghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Khordad Blvd., Alley 54, Alley 12, No. 8</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3714834141</zip>
        <telephone>+98 25 3722 3661</telephone>
        <email>mortezamoghari@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years
Patients with breast and esophageal, gastric and intestinal cancers (due to the same drugs used)
Healthy sense of smell: Measurement by smelling alcohol
No history of asthma or chronic obstructive pulmonary disease
Lack of sensitivity to plant essential oils
Having a minimum nausea score of 2 based on vas criteria on the first day of study
No more anxiety score of 63
Do not take sedatives or other medications (such as using herbal essential oils, regular exercise) to reduce anxiety for six weeks before the intervention
Not addicted to drugs
Perform chemotherapy once a week
Patients with stage I, II cancer
The goal of chemotherapy is therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of other Complementary therapies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours a drop of sour lemon essential oil onto a paper towel with a drip during chemotherapy and attaches it to the collar of the research unit with a pin, then asks him to breathe normally. This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed.</i_keyword>
      <i_keyword>Control group: In addition to the usual care of the ward (Geranisetron and Dexamethasone), the researchist pours  3 ml of water (placebo) poured on the paper and the collar is connected sick during chemotherapy.This method will be used once a week (during chemotherapy) for 4 weeks. The intervention of 5 minutes before the start of chemotherapy until receiving chemotherapy treatment for patients will be done. Aromatherapy with lemon essential oil is performed when the patient is lying on the bed and the paravan is lying around his bed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea, vomiting. Timepoint: Before and during the intervention. Method of measurement: Visual criteria for nausea and vomiting.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Aََnxiety. Timepoint: Before and during the study. Method of measurement: Spielberger's Anxiety Questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-06</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ravand Street, Kashan University of Medical Sciences. Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
