<?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>IRCT2016112131002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-03</date_registration>
      <primary_sponsor>Vice chancellor for Research, Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of aromatherapy with essential oils of orange and red flowers on pain after abdominal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of aromatherapy with essential oils of orange and red flowers on pain after abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24467</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain after surgery.</hc_freetext>
      <i_freetext>Intervention 1: In the aromatherapy group with orange essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of orange essential oil was poured on a tissue and tied to the patient’s shirt collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention. Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain. Intervention 2: In the aromatherapy group with  rose essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of  rose essential oil was poured on a tissue and tied to the patient’s shirt  collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention.&#13;
Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain. Intervention 3: In the control group, patients only received the routine care and then the pain intensity was measured immediately after patient’s gaining full consciousness 4, 8, 12 hours after the operation.</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>moloud farmahini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing Faculty of Nursing and Midwifery/building university Payambar Azam/Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 1417 3524</telephone>
        <email>farahani91@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>moloud farmahini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing Faculty of Nursing and Midwifery /Payambar Azam university complex/Basij square Arak/building university Payambar Azam/Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 1417 3524</telephone>
        <email>farahani91@arakmu.ac.ir</email>
        <affiliation>Department of Nursing Faculty of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria including: 1- patients should be between 18-40 years old, 2- patients should not suffer from acute and chronic pains, 3- patients should not suffer from vision problems, 4- patients should not suffer from mental problems, 5- patients’ sense of smell should be sound, 6- patients should not suffer from any respiratory problems or allergic rhinitis, and 7- patients should not have any experience of hospitalization or medical measures due to mental problems. Also, the exclusion criteria include 1- patients use the other herbal extracts simultaneously, 2- respiratory problems or allergic rhinitis emerge during intervention,  and 3- the occurrence of a crisis or an unexpected event during intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified abdominal pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the aromatherapy group with orange essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of orange essential oil was poured on a tissue and tied to the patient’s shirt collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention. Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain.</i_keyword>
      <i_keyword>In the aromatherapy group with  rose essential oil , during 12 hours after the surgery (immediately after that the patient regains full consciousness, 4, 8, and 12 hours after operation), 1-2 drops of  rose essential oil was poured on a tissue and tied to the patient’s shirt  collar with a pin 10 cm away from the patient’s head. The Visual Analog Scale (VAS) was used to assess the patient’s pain intensity half an hour after each intervention.&#13;
Since the aromatherapy is used as a supportive treatment method, so the conventional treatments of surgery ward were used to control the patient’s pain.</i_keyword>
      <i_keyword>In the control group, patients only received the routine care and then the pain intensity was measured immediately after patient’s gaining full consciousness 4, 8, 12 hours after the operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain after abdominal surgery. Timepoint: After recovery from anesthesia،4،8 and 12 hours after surgery. Method of measurement: Pain measured by VAS.</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>Vice chancellor for Research, Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-18</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Payambare Azam Complex, Sardasht Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
