<?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>IRCT2017041533430N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of inhalation aromatherapy on test anxiety level</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of inhalation aromatherapy with blending essential oil of Lavender and Rose on test anxiety level in nursing student of Hormozgan university of medical scineces, 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Test anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: In the experimental group, the demographic and STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the  students’ entrance, 3 drops of rose essential oil 10% and 7 drops of lavender essential oil 10%, on a piece of non-absorbent fabric will be attached to the arms of their chairs. Before the treatment, 15 minutes after it, and at the end of the examination, the anxiety inventory STAI and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends. Intervention 2: Intervention 2: In the placebo group, the demographic and the STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the students’ entrance, 10 drops of sesame oil on a piece of non-absorbent fabric will be attached to the arms of their chairs. Fifteen minutes after the students’ entrance, the STAI anxiety questionnaire will be completed again and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends.</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>Narges Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Resalat Jonubi, Bandar Abbas, Hormozgan, Iran.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5240 5202</telephone>
        <email>setare137093@yahoo.com</email>
        <affiliation>Faculty of nursing and midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Resalat Jonubi street, Bandar Abbas, Hormozgan, Iran.</address>
        <city>Bandar Abas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5240 5202</telephone>
        <email>setare137093@yahoo.com</email>
        <affiliation>Faculty of nursing and midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The subjects should tend to participate in the study; The subjects should not have impaired sense of smell; The subjects should not have asthma and allergies to flowers, respiratory disease, heart problems, epilepsy, skin diseases, and psychological disorders; The subjects should not have used aromatherapy and other complementary medicine techniques such as progressive muscle relaxation, music therapy and the like to reduce test anxiety for a period of six weeks before their examination. And finally, the subjects should not have used anti-anxiety drugs and herbal medicines during that period. Exclusion criteria: The firm's unwillingness to continue participating in the study; The subjects showing signs of allergy to rose and lavender essential oil during the study or feeling bad during the treatment; The appearance of any physical symptoms in the subjects resulting in their inability to continue the experiment.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: In the experimental group, the demographic and STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the  students’ entrance, 3 drops of rose essential oil 10% and 7 drops of lavender essential oil 10%, on a piece of non-absorbent fabric will be attached to the arms of their chairs. Before the treatment, 15 minutes after it, and at the end of the examination, the anxiety inventory STAI and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends.</i_keyword>
      <i_keyword>Intervention 2: In the placebo group, the demographic and the STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the students’ entrance, 10 drops of sesame oil on a piece of non-absorbent fabric will be attached to the arms of their chairs. Fifteen minutes after the students’ entrance, the STAI anxiety questionnaire will be completed again and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Test anxiety. Timepoint: Before the intervention, 15 min after the intervention, at the and of the exam. Method of measurement: Spielberger state-trait.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic BP. Timepoint: Before the intervention, 15 minutes after the intervention, at the end of the exam. Method of measurement: Manometer.</sec_outcome>
      <sec_outcome>Diastolic BP. Timepoint: Before the intervention, 15 minutes after the intervention, at the end of the exam. Method of measurement: Manometer.</sec_outcome>
      <sec_outcome>Pulse rate. Timepoint: Before the intervention, 15 minutes after the intervention, at the end of the exam. Method of measurement: CHronometer.</sec_outcome>
      <sec_outcome>Breath rate. Timepoint: Before the intervention, 15 minutes after the intervention, at the end of the exam. Method of measurement: CHronometer, Chest movement.</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, Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-07</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, SHahid Mohammadi Hospital, Islamic Republic of Iran Blvd, Bandar Abbas, Hormozgan, Iran. Bandar Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
