<?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>IRCT201606144281N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-20</date_registration>
      <primary_sponsor>Vice chancellor for research, shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effects of aromatherapy on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of aromatherapy with Lavender oil and Caria Chamomilla on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly in Shahroud–A clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>183</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In the present study according to exclusion criteria, participants that distinguish the smell of Lavender oil and Caria Chamomilla will be excluded. So participants will be blind to the type of intervention. Also, due to the time of data collection (before, the first day and one month after the intervention),when there is no smell of Lavender oil and Caria Chamomilla at home, so data collector who is someone other than the principal investigator, will be unaware to the type of intervention. Data analyst will be unaware of groups (experimental and control group) too, therefore, this is a triple-blind study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Self-esteem ,Sleep quality, stress, anxiety, depression , quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 3 drop of lavender essential oil on the participant’s pillow at night, repeated for 30 day. Intervention 2: Intervention group 2: 3 drop of Chamomile essential oil on the participant’s pillow at night, repeated for 30 day. Intervention 3: control group: 3 drop of Distilled water on the participant’s pillow at night, repeated for 30 day.</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>Azam Hamidzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences, Hafte-Tir square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3613773955</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>azhamidzade@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hossein Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences, Hafte-Tir square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3613773955</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>h_ebrahimi43@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Minimum age 65 years; The lack of psychiatric disease;  No history of anti-anxiety drugs, stress and depression; The ability to communicate verbally; No known respiratory problems such as asthma; Independence or any addiction to drugs; tranquilizers.  Exclusion criteria: History of asthma and allergies to flowers and plants; Smell disorders;  History of psychiatric disorders; A history of tensions event  in the last 3 months; Herbal remedies and alternative medicine use in a week.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F88-G47.9-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of psychological development-Sleep disorder, unspecifiedAcute stress reaction-Anxiety disorder, unspecified-Mild depressive episode-Person encountering health services in unspecified circumstances</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 group 1: 3 drop of lavender essential oil on the participant’s pillow at night, repeated for 30 day</i_keyword>
      <i_keyword>Intervention group 2: 3 drop of Chamomile essential oil on the participant’s pillow at night, repeated for 30 day.</i_keyword>
      <i_keyword>control group: 3 drop of Distilled water on the participant’s pillow at night, repeated for 30 day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self steam. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Questionnaire measured self-esteem scale of Rosenberg.</prim_outcome>
      <prim_outcome>Quality of sleep. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Pittsburgh Sleep Quality Iquestionare (PSQI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Questionnaire of Stress, Anxiety and Depression-DASS-21.</sec_outcome>
      <sec_outcome>Anxitey. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Questionnaire of Stress, Anxiety and Depression-DASS-21.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Questionnaire of Stress, Anxiety and Depression-DASS-21.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after intervention (The first day and one month after the intervention). Method of measurement: Quality of life Questionnaire SF12.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>ندارد</sec_id>
        <issuing_authority>ندارد</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-12</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahrood University of Medical Sciences, Hafte-Tir square Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
