<?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>IRCT20130616013690N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lemon essence on patients undergoing lower limb fractures surgeries</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lemon essence on anxiety, physiological indices and post-operative nausea &amp; vomiting in patients undergoing lower limb fractures surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57331</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Firstly, Rajai and Namazi hospitals are selected as two separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 45 patients are randomly divided into the intervention or control groups, Blinding description: To conducting blinding, assistant researcher who collects data, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lower limb fracture surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery. Intervention 2: Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Primary outcomes would be shared.

When:
Starting 6 months after publication article

To whom:
People and researchers working in academic institutions

Conditions:
Data are provided for information only.

Where to obtain:
Data is available via email rambodma@yahoo.com.

How to obtain:
Data is available via email rambodma@yahoo.com.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936–13119</zip>
        <telephone>+98 71 3677 4254</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>rambodma@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Lower Limb Fracture Surgery
Hospitalization in orthopedic surgery Wards for 24 hours before surgery
Being 18 years old or above
Being oriented to time, person and place</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant
The patient has olfactory problems, and nasal injury
Being known case of psychological diseases (major depression, anxiety, psychosis, etc.)
Participated in previous studies received complementary and alternative interventions from a week before the intervention
Transfer to ICU after surgery
Requires postoperative ventilator
Death of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T84.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Breakdown (mechanical) of internal fixation device of bones of limb</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.</i_keyword>
      <i_keyword>Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: In the morning of the surgery and the day after surgery at 8 A.M. Method of measurement: State-Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Physiological indices (blood pressure, SPO2, respiration, temperature and pain). Timepoint: In the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery. Method of measurement: Digital blood pressure monitors, Pulse Oximeter, Chronometer, MASTECH Non Contact Infrared Medical Thermometer and numeric analogue pain.</prim_outcome>
      <prim_outcome>Neurovascular assessment of lower limb. Timepoint: In the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery. Method of measurement: WACHS Neurovascular Observation Charts.</prim_outcome>
      <prim_outcome>Post-operative nausea and vomiting. Timepoint: In the post-operative anesthesia care unit, 4, 8, 12 and 16 hours after surgery. Method of measurement: Rhodes Index of Nausea, Vomiting and Retching and Numeric Analogue scale.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-08</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery, Management and Medical Information Sc</contact_name>
        <contact_address>Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
