<?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>IRCT20221101056375N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-14</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Lemon scent on the anxiety of patients before rhinoplasty surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Lemon scent on patients before rhinoplasty surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this randomized controlled clinical trial study, at first, 30 patients who are candidates for rhinoplasty who are about to be operated on are selected in the form of easy access. The number of subjects will put cards with numbers 1 and 2 in an envelope. And the patients are asked to draw a card from the envelope. Patients with card number 1 will be in the test group and patients with card number 2 will be in the control group, Blinding description: In the intervention group, 3 drops of Lemon essential oil were dripped on the medical gauze using a dropper and attached to the patient's neck, and it is recommended to inhale normally for 20-30 minutes. For the control group, 3 drops of odorless liquid of the same color (water + color of desired essential oil) of Lemon essential oil used for the intervention group, are poured on a medical gauze and connected to the patient's collar like the intervention group, and it is recommended for 20 Inhale normally for 30 minutes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>It is not a disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3 drops of Lemon essential oil from Kashan  Barij Essential Oil Company. The main components of Lemon essential oil used include: limonene (68.2%), betapinene (12.8%), gamma terpinene (8.8%) and alpha pinene (2.2%).Using a medical gas dropper 10x10 from Harir Novin Sepahan company, it drips and is connected to the patient's neck and it is recommended to inhale normally for 20-30 minutes. Intervention 2: Control group: For the control group, 3 drops of odorless liquid of the same color (water + the color of the desired essential oil) of the Lemon essential oil used for the intervention group were poured on a 10 x 10 medical gauze and connected to the patient's collar as in the intervention group, and it is recommended to Inhale normally for 20 to 30 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Amirshekari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Alley 5,Pasdaran Boulevard,</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>78616-15517</zip>
        <telephone>+98 34 4331 6688</telephone>
        <email>amirshekarimaryam@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Amirshekari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 5,Pasdaran Street</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>78616-15517</zip>
        <telephone>+98 34 4331 6688</telephone>
        <email>amirshekarimaryam@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy sense of smell
No history of asthma or chronic obstructive pulmonary disease
Insensitivity to herbal essential oils
Not taking sedatives
Not having mental and anxiety diseases</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking sedatives
Lack of consent to participate in the study
History of respiratory disease
History of allergy to lemon essential oil</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 3 drops of Lemon essential oil from Kashan  Barij Essential Oil Company. The main components of Lemon essential oil used include: limonene (68.2%), betapinene (12.8%), gamma terpinene (8.8%) and alpha pinene (2.2%).Using a medical gas dropper 10x10 from Harir Novin Sepahan company, it drips and is connected to the patient's neck and it is recommended to inhale normally for 20-30 minutes.</i_keyword>
      <i_keyword>Control group: For the control group, 3 drops of odorless liquid of the same color (water + the color of the desired essential oil) of the Lemon essential oil used for the intervention group were poured on a 10 x 10 medical gauze and connected to the patient's collar as in the intervention group, and it is recommended to Inhale normally for 20 to 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and after the intervention. Method of measurement: Spiegelberger questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose manifest anxiety questionnaire score is less than 40. Timepoint: Before and after the intervention. Method of measurement: Calculation of the score of the Spiegelberger questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose overt anxiety questionnaire score is above 60. Timepoint: Before and after the intervention. Method of measurement: Calculation of the score of the Spiegelberger questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose anxiety questionnaire score is above 60. Timepoint: Before and after the intervention. Method of measurement: Calculation of the score of the Spiegelberger questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose hidden anxiety questionnaire score is less than 40. Timepoint: Before and after the intervention. Method of measurement: Calculation of the score of the Spiegelberger questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Overt anxiety score. Timepoint: Before and after the intervention. Method of measurement: Spiegelberger questionnaire.</sec_outcome>
      <sec_outcome>Latent anxiety score. Timepoint: Before and after the intervention. Method of measurement: Spiegelberger questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-30</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica</contact_name>
        <contact_address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
