<?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>IRCT20180303038934N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The Comparative study on the Effect of Aromatherapy with Lavender and damask rose on Obvious Anxiety Level of the endoscopy Candidate Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Comparative study on the Effect of Aromatherapy with Lavender and damask rose on Obvious Anxiety Level of the endoscopy Candidate Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30050</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: Samples will be drawn by lottery and will be randomly assigned to the studied groups. After reviewing the eligible patients, they will be satisfied.
A draw box in which there are three paper with numbers 1, 2 and 3 in it is provided to the patient to randomly remove a number.  That number represents the group in which it is placed.  If the number of samples of each group is completed, that number will be withdrawn from the lottery container. This will continue to the required number of samples for all three groups, Blinding description: All actions, including the completion of questionnaires and the use of essential oils, are done by a researcher and the study is  single blind, and the patients in all three groups are not informed of any of the groups studied and their differences. But the researcher is aware of the difference in groups and essential oils due to the categorization of the patients in the three groups and the implementation of the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Upper gastrointestinal endoscopy. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: One hour before endoscopy, two drops of 10% lavender essential oil (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar with a pin. The patient is asked to wait for 30 minutes Take a normal breath. Intervention 2: Intervention group 2: One hour before the patient goes to endoscopy, two drops of Damask Rose essential oil with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 30 minutes. Intervention 3: Control group: One hour before the patient goes to endoscopy, two drops of odorless soy oil (placebo) with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Based on the goals in the design, the amount of anxiety is reported before and after the aromatherapy and some of the individual information listed in the Variables section

When:
Starting from the second half of 2019

To whom:
Researchers, Guilan University of Medical Sciences, samples of study, University and Hospital Researchers

Conditions:
Data after analysis, is available to others through publication in scientific journals

Where to obtain:
maryam mirzaee and Arezoo monfared
Email : msnurse_mirzaee@yahoo.com
Address: Student Ave., Shahid Beheshti Blu., Rasht, Iran
Postal code: 41635- 1873
Tel: +98 13 3355 5056
Tel: +98 911 766 3251

How to obtain:
Usually, information will be available through the publication of the paper.
But if the person asks for more and more information, can submit application by email and phone and in person.
Then information will be provided according to the size and type of data that will be considered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mirzaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student Ave., Shahid Beheshti Blu., Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1873- 41635</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>msnurse_mirzaee@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Mirzaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student Ave., Shahid Beheshti Blu., Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1873- 41635</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>msnurse_mirzaee@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be alert (relative to location, time, and surrounding)
Gastrointestinal endoscopy for the first time.
Not mental illness and anxiety, mental retardation, blindness and deafness.
any disorder have not sense of smell.
Do not use anti-anxiety and opioid drugs
There is no history of severe psychological stress during endoscopy (such as relatives death ).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute pain when completing the questionnaire.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K25</hc_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastric ulcer</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: One hour before endoscopy, two drops of 10% lavender essential oil (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar with a pin. The patient is asked to wait for 30 minutes Take a normal breath.</i_keyword>
      <i_keyword>Intervention group 2: One hour before the patient goes to endoscopy, two drops of Damask Rose essential oil with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 30 minutes.</i_keyword>
      <i_keyword>Control group: One hour before the patient goes to endoscopy, two drops of odorless soy oil (placebo) with a concentration of 10% (the product of Barij Essen Company) are placed on a cotton ball and attached to the patient's collar by the pin. They are asked to breathe normally for 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spielberger state anxiety score; score of 21-39 indicates mild anxiety, 40-59 average anxiety and 60-80severe anxiety. Timepoint: The beginning of the study (before the intervention) and the end of the intervention, the questionnaire will be completed. Method of measurement: Spielberger state anxiety Inventory.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-27</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>In Front of the 17 Shahrivar Hospital .,Seiadati Ave., Namjo Ave., Rasht City Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
