<?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>IRCT2017050333794N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-05</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Cardamom aromatherapy on the women's nausea and vomiting in Cesarean Section operation</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Cardamoms Inhalation Aromatherapy on the Mothers' Nausea and Vomiting in Peri &amp; Post-Operation of the Elective Cesarean Section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25980</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: The two 2 "× 2" gas-Pad will be moistened with 2 ml of distilled water put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the distilled water soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups. Intervention 2: The two 2 "× 2" gas-Pad will be moistened with 2 ml of  of distilled water with 2 drops of essential oil of cardamom put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the oil of cardamom soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.</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>Zahra Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Science, Shahid Fahmide boulevard</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8698365178</zip>
        <telephone>+98 81 1838 0319</telephone>
        <email>zkhalili90@yahoo.com</email>
        <affiliation>Hamadan, University of Medical Sciences, Nursing &amp; Midwifery School, Medical-Surgical Nursing Depart</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahnaz Khatiban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Science, Shahid Fahmide boulevard</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8698365178</zip>
        <telephone>+98 81 3838 0535</telephone>
        <email>m-khatiban@umsha.ac.ir; mahnaz.khatiban@gmail.com</email>
        <affiliation>Mother and Child Care Research Center, Hamedan University of Medical Sciences, Nursing &amp; Midwifery S</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Mothers with16-48 years old; Literacy; Singleton and normal infants; Elective Cesarean section operation through Spinal anesthesia; Nausea after starting spinal anesthesia; Lack of nausea due to the underlying disease (Gastrointestinal  and kidney diseases) or during the third trimester of pregnancy; A healthy olfactory sense; No history of asthma and respiratory distress due to cardiopulmonary diseases; No allergies to herbal essences and Cardamom; No taking antiemetic or emetic medications or herbal medications during past twenty-four hours; and no opioid addiction and tobacco using.&#13;
&#13;
Exclusion criterion: Mothers with an inappropriate process of caesarean section operation (both mother and fetus poor conditions); More than twice spinal needle insertions or use of general anesthesia follow it; An inability to determine the severity of nausea according to VAS despite training; Vomiting or retching during the research intervention.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>48 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>O82.9 Delivery by caesarean section, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The two 2 "× 2" gas-Pad will be moistened with 2 ml of distilled water put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the distilled water soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.</i_keyword>
      <i_keyword>The two 2 "× 2" gas-Pad will be moistened with 2 ml of  of distilled water with 2 drops of essential oil of cardamom put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the oil of cardamom soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of nausea of mothers' peri- &amp; post-operation of the Cesarean Section. Timepoint: Before the intervention (initial measurement), 5 minutes after intervention, Post-Operation: in the recovery room and 2 hours after operation. Method of measurement: Visual Analogue Scale (VAS 0-100).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency of  vomiting. Timepoint: during surgery, in the recovery room and 2 hours after operation. Method of measurement: Frequency.</sec_outcome>
      <sec_outcome>Frequency of  retching. Timepoint: during surgery, in the recovery room and 2 hours after operation. Method of measurement: Frequency.</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 of Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-22</approval_date>
        <contact_name>Ethics Committee of the Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
