<?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>IRCT201505257494N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-10</date_registration>
      <primary_sponsor>Vice Chancellor for research Mazandaran University of Medical Sciences.</primary_sponsor>
      <public_title>Effect of lavender on anxiety, depression and fatigue in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with lavender Essential oil on anxiety, depression and fatigue, in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemodialysis patient.</hc_freetext>
      <i_freetext>Intervention 1: experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO / IEC 17025. Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. Since pure lavender essence is highly concentrated and its use irritates the patients, the essence is diluted with sweet almond oil. In experimental group a cotton ball soaked with 2 drops of lavender essential oil with concentrations of 10% in the first week (3 first session), 20% in the second week (3 second session ), 30% in the third week (3 third session), 40% in the week fourth (3 fourth session) and 50% in the fifth week (3 fifth sessions ) attached to his collar and he will be asked to breathe normally for 20 minutes. Intervention 2: Patients in the control group will be received usual care.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Attieh Nikkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815696869</zip>
        <telephone>+98 11 3337 1010</telephone>
        <email>atinik1357@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3336 7345</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient including major criteria: at least 6 months of dialysis treatment; dialysis for 3 times a week; being over 18 years; alertness and ability to communicate; having a good sense of smell; have not a stressful event in the past 6 months; don't using sedatives drugs Patient eligibility major criteria: candidate for a transplant; pregnancy or decision to pregnancy; record of allergies; chronic respiratory diseases; addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Care involving dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>experimental group will be exposed to the inhalation of lavender essence produced by Barij certified pharmaceutical company with quality standards of ISO 9001 and ISO / IEC 17025. Lavender essence is produced from fresh flowering parts of the plant which contains Linalool, Linalool acetate, Caffeic acid and Tannins. Since pure lavender essence is highly concentrated and its use irritates the patients, the essence is diluted with sweet almond oil. In experimental group a cotton ball soaked with 2 drops of lavender essential oil with concentrations of 10% in the first week (3 first session), 20% in the second week (3 second session ), 30% in the third week (3 third session), 40% in the week fourth (3 fourth session) and 50% in the fifth week (3 fifth sessions ) attached to his collar and he will be asked to breathe normally for 20 minutes</i_keyword>
      <i_keyword>Patients in the control group will be received usual care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression and anxiety. Timepoint: Before intervention first week,  second week,third week, fourth week and fifth week. Method of measurement: Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Before intervention first week,  second week,third week, fourth week and fifth week. Method of measurement: Fatigue Severity Scale.</prim_outcome>
      <prim_outcome>Well being. Timepoint: Before intervention first week,  second week,third week, fourth week and fifth week. Method of measurement: visula Analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergic to Lavender. Timepoint: During five weeks of intervention. Method of measurement: Questions from Patients.</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>Vice Chancellor for research Mazandaran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-23</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Science</contact_name>
        <contact_address>Moalem Street, Moalem Square, Sari Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
