<?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>IRCT20180103038211N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-26</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Aromatherapy Effects on Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of aromatherapy with lavender on sleep quality, fatigue and anxiety in patients with Multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36965</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are entered with accessible method in the study.  Blocks randomly divide into intervention and control groups, Blinding description: Individuals with entry criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. The control group also receive similar (but not effective) intervention so containers containing essential oils are of a single form and color, so are unaware of the allocation to the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: one hour before bedtime, the lavender extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the clothes by a pin) And smell for 5-10 minutes. Intervention 2: Control group: one hour before bed, the sweet almond extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the cloth by a pin) And smell for 5-10 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Davodabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij Square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6941-7-38481</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>fahimedavodabady@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Davodabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij Square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6941-7-38481</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>Fahimedavodabady@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with MS who have Expanded Disability Status Scale (EDSS) equal or less than 4.
Patients with MS aged 18 to 50 years old
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of other complementary and alternative methods during the study
Sleeping and sedative medications, antidepressants and analgesics during the study
History of asthma or respiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35-G37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: one hour before bedtime, the lavender extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the clothes by a pin) And smell for 5-10 minutes.</i_keyword>
      <i_keyword>Control group: one hour before bed, the sweet almond extract was put on a cotton ball for 2 to 3 drops every night for 4 weeks and placed at a distance of 10 to 15 centimeters (the cotton ball is attached to the cloth by a pin) And smell for 5-10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality with Pittsburgh Sleep Quality Questionnaire. Timepoint: Measurement of sleep quality at the beginning of the study and the end of the fourth week after the intervention began. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Fatigue with Fatigue Impact Scale MS. Timepoint: Measurement of fatigue at the beginning of the study and the end of the fourth week after the intervention began. Method of measurement: Fatigue Impact Scale MS.</prim_outcome>
      <prim_outcome>Anxiety with State-Trait Anxiety Inventory (STAI). Timepoint: Measurement of anxiety at the beginning of the study and the end of the fourth week after the intervention began. Method of measurement: State-Trait Anxiety Inventory (STAI).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-04</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Basij Square, Sardasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
