<?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>IRCT20210502051161N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-04</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>investigating the effect of aromatherapy with Damask Rose essence on students' anxiety caused by the  OSCE test</public_title>
      <acronym></acronym>
      <scientific_title>Investigating of the effect of aromatherapy with Damask Rose essence on the anxiety caused by the OSCE in anesthesia, operating room and nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75181</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method in this research was simple with random allocation, in which based on the list of operating room, anesthesia and nursing students using a table of random numbers, the first selected number from the class list of students was placed in the test group and so on. The second number was placed in the control group. Allocation of samples in two groups continued until the number of samples was completed, Blinding description: The students of the test and control groups are placed in two separate places. In the test group, two drops of 40% rose essence are poured on cotton and given to the test group. For students in the control group, two drops of distilled water will be poured on the cotton as a placebo and will be provided to them. The bottle containing distilled water and rose essence will be of the same shape and none of them will have a specification label and will be marked with labels A (Damask rose essence) and B (distilled water) to distinguish them. Then the students are asked to inhale it from a distance of 5 cm for 10 minutes. In order to carry out this intervention and control the duration of inhalation, two people will be present in the room as observers, so that the observers after Delivery of cotton soaked with essential oil or distilled water to the students, they are informed that they will start inhalation and they will monitor the students using a timer for ten minutes. After ten minutes, the supervisors ask the students to stop inhalation and put the inhaled cotton balls in the bags placed on the chair handle. The intervention will be done before the start of the Asci test during the pre-test quarantine. And it is done first on the control group and then on the students of the test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety.</hc_freetext>
      <i_freetext>Intervention group: Before the intervention, the students of the test group are asked to answer Sarason's test anxiety questionnaire. In the test group, two drops of 40% rosehip essence, belonging to Barij Essan Company of Kashan, are poured on the cotton and given to the test group. Then the students are asked to smell it from a distance of 5 cm for 10 minutes. In order to carry out this intervention and control the duration of inhalation, two people will be present in the room as observers, in such a way that the observers after delivery Cottons soaked with essence are given to the students, they are informed that they will start inhalation and they will monitor the students using a timer for ten minutes. After ten minutes, the supervisors ask the students to stop inhalation and put the inhaled cotton balls in the bags placed on the chair handle. The intervention before the start of the Ascii test will be done during the pre-test quarantine. Then the test (Sarason Anxiety Questionnaire for the second time) will be completed 5 minutes after the end of the intervention, with the announcement of the supervisors..</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>Hamidreza Nejati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari St., Jahrom University of Medical Sciences, Pardis site</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 74 1484 6199</telephone>
        <email>Hamidrezaa891425@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahareh Mahdood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom University of Medical Sciences, end of Ostad Motahhari Blvd.</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0405</telephone>
        <email>baharehmahdood68@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not having a diagnosed mental illness
Not having a history of anxiety disorders
Absence of disturbance in the sense of smell
Absence of chronic migraine headaches
Absence of underlying diseases including cardiovascular disease, epilepsy, skin disease and allergy
No history of allergy to the smell of plants
Willingness to participate in research and complete written informed consent to participate in the study
The desire to smell the smell of roses</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Leaving the exam site for any reason during the study intervention
Lack of motivation of the research unit to continue cooperation
Taking drugs that affect anxiety
Use of perfume
Incomplete completion of questionnaires
Students with underlying diseases/asthma or seasonal allergies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the intervention, the students of the test group are asked to answer Sarason's test anxiety questionnaire. In the test group, two drops of 40% rosehip essence, belonging to Barij Essan Company of Kashan, are poured on the cotton and given to the test group. Then the students are asked to smell it from a distance of 5 cm for 10 minutes. In order to carry out this intervention and control the duration of inhalation, two people will be present in the room as observers, in such a way that the observers after delivery Cottons soaked with essence are given to the students, they are informed that they will start inhalation and they will monitor the students using a timer for ten minutes. After ten minutes, the supervisors ask the students to stop inhalation and put the inhaled cotton balls in the bags placed on the chair handle. The intervention before the start of the Ascii test will be done during the pre-test quarantine. Then the test (Sarason Anxiety Questionnaire for the second time) will be completed 5 minutes after the end of the intervention, with the announcement of the supervisors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score obtained from the TAS questionnaire. Timepoint: Immediately before and five minutes after aromatherapy. Method of measurement: TAS questionnaire.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-13</approval_date>
        <contact_name>Ethics committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Ostad Motahari Blvd., after Nursing Faculty, Jahrom University of Medical Sciences, Pardis site Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
