<?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>IRCT20100913004736N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-11</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with the essential oils of lavender and peppermint on sleep quality of cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on sleep quality of cancer patients admitted to Taleghani Hospital in Kermanshah, 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27904</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To do this, formulate the Excel software environment and generate random numbers of 5 digits. Anyone who enters the study is assigned a number, the last number on the right will be decisive. Patients with the last digits to the right of these numbers are 1, 2.3, will be in Lavender group.Patients whose last digit is 4, 5, 6, and Patients with a final digit of 7, 8, 9 will be assigned in the peppermint and control group respectively.
,.</study_design>
      <phase>2</phase>
      <hc_freetext>Cancer disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In group one , for seven nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Barich Essence Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Menton and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the collar and inhaled for 20 minutes. Intervention 2: Intervention group: In group Two , for seven nights before going to sleep at 22 o'clock, the Three  drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Barich Essence Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the Collar  and inhaled for 20 minutes. Intervention 3: Control group: In this group, for seven nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the  Collar and inhaled for 20 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:
Data on the main outcome of the study is available for sharing.

When:
Six months after the publication of the results in the form of the article

To whom:
Researchers working in academic institutions

Conditions:
Only to conduct similar studies in other populations.

Where to obtain:
Alireza Khatuni with below email address:
 akhatony@gmail.com
and phone number 08338282102

How to obtain:
A week after receiving an email or phone call, it will take action.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah, Iran</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>67</zip>
        <telephone>+98 38279394</telephone>
        <email>akhatony@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashayer Sreet, Kermanshah School of Nursing and Midwifery, Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714634698</zip>
        <telephone>+98 382789394</telephone>
        <email>akhatony@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The satisfaction of the patient's physician and the informed consent of the patient to participate in the study
Having full consciousness
positive reaction to smell
Ability to answer questions
The absence of any physical pain
the stability of vital signs (blood pressure, pulse, respiration and temperature)
having aged 18 to 65 years
Lack of sinusitis and nasal septum deviation and skin sensitivities
No addiction to drugs and alcohol and smoking
The absence of acute clinical conditions such as nausea and vomiting
Not having a history of respiratory problems such as asthma
Do not drink caffeine drink from an hour before the intervention
Earn points equal to or more than five from the Pittsburgh Sleep Quality Questionnaire
Lack of primary tumor or metastasis in the central nervous system</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation by the patient or his/her physician
Transition to other wards
Receiving narcotic during aromatherapy
Oxygen administration for the patient
Occurrence of Crisis or unforeseen incident</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z85.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of malignant neoplasms of other organs and systems</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In group one , for seven nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Barich Essence Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Menton and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the collar and inhaled for 20 minutes.</i_keyword>
      <i_keyword>Intervention group: In group Two , for seven nights before going to sleep at 22 o'clock, the Three  drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Barich Essence Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the Collar  and inhaled for 20 minutes.</i_keyword>
      <i_keyword>Control group: In this group, for seven nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the  Collar and inhaled for 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality; In this study, patients with a score of 5 or more from the Pittsburgh Questionnaire are enrolled in the study. Timepoint: At the beginning of study and Eighth day. Method of measurement: Pittsburgh Sleep Quality Questionnaire will be used.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-28</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی کرمانشاه</contact_name>
        <contact_address>Shahid Beheshty Blvd., Kermanshah University of Medical Sciences, Kermanshah, Iran kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
