<?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>IRCT20180324039145N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-05</date_registration>
      <primary_sponsor>Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology</primary_sponsor>
      <public_title>Rose oil aromatherapy treatments for preoperative anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effects of aromatherapy using rose oil (Rosa damascena Mill.) on preoperative anxiety: A prospective randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30335</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Microsoft Exel random number generator function will be used with blocks of 30 for randomization as the control group (Group C), the sham group (Group S) and the rose oil group (Group R).  The volunteers will be randomized with closed envelope method (number of 1-30) as 1: 1: 1 in operation morning. Randomization will be repeated every 30 patients, Blinding description: Heart rate, systolic-diastolic blood pressure of patients will be measured when patients arrive at the otorhinolaryngology clinic service.
The first STAI TX-1 (State-Trait Anxiety Inventory) (preop 1) test will be performed by a researcher and responses will be recorded in the case report form.
The patients do not know which they are groups due to closed envelop method.   Aromatherapy will be implemented according to the patient's group by the care provider.
The other investigator and outcome assessor will be in the operating room.
In the operating room, the second STAI TX-1 test will be performed by the researcher who does not know in which group the volunteers are in the group. Preoperative heart rate, systolic-diastolic blood pressure of patients will be measured and recorded as preop 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preoperative anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: rose oil group (Group R). Intervention 2: Intervention group: the sham group (Group S). Intervention 3: Control group: the control group (Group C).</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:
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.

When:
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.

To whom:
All data will be shared by the open access manuscript.

Conditions:
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.

Where to obtain:
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.

How to obtain:
All data will be shared by the open access manuscript.And the corresponding author can send all data or documents by e-mail.

Comments:
All data will be shared by the open access manuscript. And the corresponding author can send all data or documents by e-mail.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Recai Dagli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kervansaray Mh.</address>
        <city>Kirsehir</city>
        <country1>Turkey</country1>
        <zip>40100</zip>
        <telephone>+90 386 213 45 15</telephone>
        <email>recai.dagli@ahievran.edu.tr</email>
        <affiliation>Ahi Evran University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehmet Metin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kervansaray</address>
        <city>Kirsehir</city>
        <country1>Turkey</country1>
        <zip>40100</zip>
        <telephone>+90 386 213 45 15</telephone>
        <email>drmehmetmetin@gmail.com</email>
        <affiliation>Ahi Evran University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients who will have Septorhinoplasty operation
ASA (American Society of Anesthesiologists) I-II risk group
Between the ages of 18-40</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hypertension,
Cardiac dysrhythmia
Chronic depression and anxiety treatment
Allergy to aromatherapy oils
Bronchospasm
Anosmia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: rose oil group (Group R)</i_keyword>
      <i_keyword>Intervention group: the sham group (Group S)</i_keyword>
      <i_keyword>Control group: the control group (Group C)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The first STAI TX-1 (State-Trait Anxiety Inventory) (preop 1) test will be performed by a researcher and responses will be recorded in the case report form. Timepoint: In the operating room, the second STAI TX-1 test will be performed by the researcher who does not know in which group the volunteers are in the group. Method of measurement: STAI TX-1 (State-Trait Anxiety Inventory)  test.</prim_outcome>
      <prim_outcome>Heart rate, systolic-diastolic blood pressure of patients will be measured when patients arrive at the otorhinolaryngology clinic service. Timepoint: In the operating room, preoperative heart rate, systolic-diastolic blood pressure of patients will be measured and recorded as preop 2. Method of measurement: Blood pressure using sphygmomonometer , heart rate using ECG.</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>Ahi Evran University Training and Research Hospital Department of Otorhinolaryngology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-31</approval_date>
        <contact_name>Ahi Evran University Clinical Investigations Ethics Committee</contact_name>
        <contact_address>Bagbasi Mh. Kirsehir Kirsehir Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
