<?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>IRCT2014041417267N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-25</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of peppermint on nausea severity.</public_title>
      <acronym></acronym>
      <scientific_title>The effects of inhalation aromatherapy on nausea severity in patients admitted for abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nausea.</hc_freetext>
      <i_freetext>Intervention 1: In this study the researcher, after patients transferring from operating room to the surgical ward and stabilizing their vital signs performs the intervention between 2 groups. In the first group that received inhalation aromatherapy,we used the solution that contains Peppermint extract(0/2 ml of  peppermint solution 10%  in 2 ml of distilled water) for 5 minute. In the other group that received inhalation aromatherapy, we used the solution that contains Peppermint extract(0/2 ml of peppermint solution 30%  in 2 ml of distilled water) for 5 minute.The Desired solutions(0/2 ml of peppermint solution in 2 ml of distilled water) were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes. Intervention 2: In the control group, distilled water is used. two ml of distilled water were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes.  Nausea severity is measured  5 and 10 min after the intervention with VAS(Visual Analog Scale) in control group and comparison is done between 3 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>Yasin Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Ahmadi Alley,Shahid Rajaie Street, Salas Babajani, Kermanshah</address>
        <city>Salas Babajani</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>67771-36866</zip>
        <telephone>+98 932 672 2330</telephone>
        <email>mallagyan492@gmail.com; &#13;
sobaydarin@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasin Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Ahmadi Alley,Shahid Rajaie Street, salas babajani</address>
        <city>Salas Babajani</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>67771-36866</zip>
        <telephone>+98 83 2672 2330</telephone>
        <email>mallagyan492@gmail.com;sobaydarin@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients has been undergoing abdominal surgery; Having a good sense of smell(Ability to detect the scent of peppermint); Ages between 15 to 65 years;  Having a good eyesight(to detect the severity of  nausea on VAS); Having consciousness; Not suffering from asthma and other allergic diseases; Non-smoking; Receiving a type of anesthesia(general); Receiving a group of drug during anesthesia(Nesdonal and Isoflurane). Exclusion Criteria:  Patient with lack of cooperation during the study; Loss of consciousness; Receiving Antiemetic drugs; Receiving narcotic drug(Morphine and Pethidine)during the study.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</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 this study the researcher, after patients transferring from operating room to the surgical ward and stabilizing their vital signs performs the intervention between 2 groups. In the first group that received inhalation aromatherapy,we used the solution that contains Peppermint extract(0/2 ml of  peppermint solution 10%  in 2 ml of distilled water) for 5 minute. In the other group that received inhalation aromatherapy, we used the solution that contains Peppermint extract(0/2 ml of peppermint solution 30%  in 2 ml of distilled water) for 5 minute.The Desired solutions(0/2 ml of peppermint solution in 2 ml of distilled water) were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes.</i_keyword>
      <i_keyword>In the control group, distilled water is used. two ml of distilled water were shed on the non Sterile gaz and the non sterile gaz is subjected to the patient's nose in a distance of 5 cm for 5 minutes.  Nausea severity is measured  5 and 10 min after the intervention with VAS(Visual Analog Scale) in control group and comparison is done between 3 group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nuasea severity. Timepoint: Before the intervention, 5 and 10 minutes after intervention. Method of measurement: Visual Analog Scale to assessment of nausea.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-04</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Blvd, Kermanshah Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
