<?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>IRCT201610244736N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-10</date_registration>
      <primary_sponsor>Vice Cancellor for Research, Kermanshah University of Medical Science</primary_sponsor>
      <public_title>Effect of aromatherapy on fatigue, anxiety and depression in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of inhalation aromatherapy with essential oil of Lavender and Orange on fatigue, anxiety and depression in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:  Before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive. For this purpose, in group one 5 drops of Lavender essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes by the patient. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients. Intervention 2: Intervention2: In group 2 before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive weeks. In group one 5 drops of Orange essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients. Intervention 3: In the control group for two consecutive weeks, 5 drops of distilled, will be dropped on a piece of cotton by dropper and it will be attached to the patient's clothing and will be inhaled by the patient for 30 minutes. Before and after the intervention the fatigue, depression and anxiety questionnaires will be completed by the samples.</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>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Boulevard, Kermanshah,Iran</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 9394</telephone>
        <email>akhatony@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khatony</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Boulevard, Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3827 9394</telephone>
        <email>akhatony@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willingness for participating in the research; doing hemodialysis three times a week; doing hemodialysis for at least 6 month; age between 18-65 year; being conscious; having verbal contact; having no allergy to essential oils of Lavender and Orange; having healthy sense of smell.&#13;
 Exclusion criteria: the patient's unwillingness to continue cooperation; become critically ill during the study; and receiving narcotic and oxygen during aromatherapy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1:  Before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive. For this purpose, in group one 5 drops of Lavender essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes by the patient. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients.</i_keyword>
      <i_keyword>Intervention2: In group 2 before intervention the fatigue, depression and anxiety questionnaires will be completed by the samples. Intervention will be conducted for two consecutive weeks. In group one 5 drops of Orange essential oil will be dropped on a piece of cotton and then it will be attached to the patient`s clothing on chest area and will be inhaled for 30 minutes. One hundred percent concentration of essential oils are used. The time of using the fragrances is half an hour after initiation of dialysis. At the end of two weeks, the questionnaires will be completed again by the patients.</i_keyword>
      <i_keyword>In the control group for two consecutive weeks, 5 drops of distilled, will be dropped on a piece of cotton by dropper and it will be attached to the patient's clothing and will be inhaled by the patient for 30 minutes. Before and after the intervention the fatigue, depression and anxiety questionnaires will be completed by the samples.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: at the beginnig of the study and fourteenth day. Method of measurement: fatigue severity scale.</prim_outcome>
      <prim_outcome>Depression. Timepoint: at the beginnig of the study and fourteenth day. Method of measurement: DASS-21 questionaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: at the beginnig of the study and fourteenth day. Method of measurement: DASS-21 questionaire.</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>Vice Cancellor for Research, Kermanshah University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-23</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Shahid Beheshty Boulevard, Kermanshah, Iran Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
