<?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>IRCT201605026888N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-06</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy lemon on nausea and vomiting of pregnancy in pregnant women referred to health centers</public_title>
      <acronym>effect Lemon aromatherapy  on nausea and vomiting in pregnancy</acronym>
      <scientific_title>The effect of aromatherapy lemon on nausea and vomiting of pregnancy in pregnant women referred to health centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nausea and Vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:After obtaining informed consent from participants, For four days and each day as soon as nausea and vomiting by mother, two drops of lemon at a concentration of 2% of the company Barij Esans  poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the cases..   &#13;
Group control:  For four days and each day as soon as nausea and vomiting by mother, two drops of placebo solution that is in the same container of lemon poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes. Intervention 2: Control group: After obtaining informed consent from participants, Mothers controlled group placebo(water) to be delivered within the bottle similar to the intervention group.For four days and each day as soon as nausea and vomiting by mother, Two drops of the contents of the glass  poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the control group.</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>Fatemeh Shobeiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>treet Shahid Fahmideh, Faculty of Nursing, Hamedan Medical Sciences University</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3827 6051</telephone>
        <email>shobeiri@umsha.ac.ir</email>
        <affiliation>Hamedan Medical Sciences University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Shobeiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>treet Shahid Fahmideh, Faculty of Nursing, Hamedan Medical Sciences University</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3827 6051</telephone>
        <email>shobeiri@umsha.ac.ir</email>
        <affiliation>Hamedan Medical Sciences University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included women ages 16 to 40 years 6 to 16 weeks gestational age; ability to read and write; singleton pregnancy by ultrasound in health records; mild to moderate nausea with or without vomiting (minimum score of 3 and a maximum score of 12, based on relevant tools); non-use of anti-nausea or vomiting within the last 24 hours, non-smoking, lack of psychological disorder or traumatic event over the last 6 months; lack of molar pregnancy and symptoms of threatened abortion and diseases such as pyelonephritis, thyroid disorders, gastrointestinal disease or any other disease with nausea and vomiting show (according to the patient and medical examination center); having phone calls, lack of problem in the olfactory system (according to patient) exclusion criteria included symptoms of allergy or intolerance to lemon during the study, not wanting to continue the study; if you use other medications during the study</inclusion_criteria>
      <agemin>16 days</agemin>
      <agemax>31 days</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>021</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild hyperemesis gravidarum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:After obtaining informed consent from participants, For four days and each day as soon as nausea and vomiting by mother, two drops of lemon at a concentration of 2% of the company Barij Esans  poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the cases..   &#13;
Group control:  For four days and each day as soon as nausea and vomiting by mother, two drops of placebo solution that is in the same container of lemon poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes.</i_keyword>
      <i_keyword>Control group: After obtaining informed consent from participants, Mothers controlled group placebo(water) to be delivered within the bottle similar to the intervention group.For four days and each day as soon as nausea and vomiting by mother, Two drops of the contents of the glass  poured onto a clean tissue Three takes a deep breath and, if necessary, be repeated every five minutes and Per day once the questionnaire is completed by the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: 6-16 weeks of pregnancy. Method of measurement: PUQE-24 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lemon aromatherapy. Timepoint: 6-16 weeks of pregnancy. Method of measurement: Drops.</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 and Technology Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-23</approval_date>
        <contact_name>Hamadan Medical Sciences University ethics committee</contact_name>
        <contact_address>Hamadan Medical Sciences University ethics committee Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
