<?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>IRCT20191007045019N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-10</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of topical application of lipogel in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of topical application of lipogel containing lavender essential oil on sleep quality and feeling good in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43655</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients were randomly assigned to each group using Permuted block Randomization as follows. To randomly assign people to different groups, we select 20 blocks of 6 that will be blocks from 120 different modes such as AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA. In each block there will be two cases of Group A, two cases of Group B and two cases of Group C. The computer program randomly selects one at a time, which is a random order of individuals. Considering the fact that women and men are separated in the Citizen's Center, patients are number 1 to 51 from the Citizens 'Center of the Citizens' Center, and from 52 to 102 from the Men's Ward of the Citizen Dialysis Center and the next 18 patients from the Mazandaran Heart Center, Blinding description: In this study, final evaluators  will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>renal disease.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: After obtaining informed consent, during the hemodialysis while the patient in the test group lay on the bed, a same person removed 5% of the Lavogula Lavender essential oil from a tube containing Lipogel with essential oil and then removed From precise measurement with the balance of a patient's legs from wrist to toe point to two finger straps and a length of 5 cm measured by a ruler uniformly, top to bottom for 1 minute. Intervention 2: second Intervention group: After obtaining informed consent, during hemodialysis while the patient in the test group was lying on the bed, a same person after wearing two grams of Lavandula Angustifulia essential oil 5% from the tube containing lipogel with The essential oil is removed and after careful measurement with a balance on the back of the patient's legs from ankle to toe, point to two fingers and 5 cm in length, as measured by a ruler, from top to bottom for 1 minute. It takes 1minutes. Intervention 3: Control group: There is no intervention by the research team and routine care is provided.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hedayat Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari, Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>hedayat2003@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hedayat Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari, Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>hedayat2003@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
18 years of age or older
End-stage kidney disease
treated regularly with dialysis at least three times a week for six months
with full alertness and ability to communicate,
literate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>no history of allergies ( skin and respiratory allergies essential oils and fragrances)
no history of mental illness,
lack of mental disorders(such as Down syndrome and dementia),
lack of experience of any stressful event in the past six months (such as death of a close relative),
lack of sedative medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rapidly progressive nephritic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group: After obtaining informed consent, during the hemodialysis while the patient in the test group lay on the bed, a same person removed 5% of the Lavogula Lavender essential oil from a tube containing Lipogel with essential oil and then removed From precise measurement with the balance of a patient's legs from wrist to toe point to two finger straps and a length of 5 cm measured by a ruler uniformly, top to bottom for 1 minute.</i_keyword>
      <i_keyword>second Intervention group: After obtaining informed consent, during hemodialysis while the patient in the test group was lying on the bed, a same person after wearing two grams of Lavandula Angustifulia essential oil 5% from the tube containing lipogel with The essential oil is removed and after careful measurement with a balance on the back of the patient's legs from ankle to toe, point to two fingers and 5 cm in length, as measured by a ruler, from top to bottom for 1 minute. It takes 1minutes</i_keyword>
      <i_keyword>Control group: There is no intervention by the research team and routine care is provided</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve sleep quality. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: The quality of sleep with the Pittsburgh Instrument.</prim_outcome>
      <prim_outcome>Feeling Well Using the yield Mental Feeling Tool. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: the instrument of yield feeling psychologically well.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-13</approval_date>
        <contact_name>Ethics committee of Mazandaran university of medical sciences</contact_name>
        <contact_address>Sari, Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
