<?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>IRCT20190428043410N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-25</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of essential oil on memory in patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of lavender, rosemary and orange essential oil on retrospective, prospective memory and drug compliance in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40113</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Minimization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, only the usual care of the dialysis units and in fact training on adherence to the drug regimen is presented, and only the drug compliance questionnaire, retrospective memory and prospective memory are completed by these individuals. Intervention 2: Intervention group: Lavender group: In this group, the samples will use lavender essential oil (2%) three times a week for the usual care (they will be manufactured by Kashan Barij Essen). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of lavender essential oil are poured into a gassus and placed within a distance of ten centimeters from the patient's nose. The lavender gas is put into a small 10cm container and the patient is asked to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients. Intervention 3: Intervention group: Routine group: In this group, the samples will use 100% essential oil (for the production of Barij Essen, Kashan) three times a week, for a period of one month. One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of daily essential oil are placed on a gas and placed at a distance of ten centimeters from the patient's nose. The daily gas is dipped in a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients. Intervention 4: Intervention group: Orange group: In this group, the samples will be used, in addition to receiving regular care, three times a week for orange essential oil (100%) (the construction of the Bariji Essential Oil Factory of Kashan). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of orange essential oil are placed on a gas and placed within a distance of ten centimeters from the patient's nose. The orange gas is put into a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data on the main implications is shared

When:
Start the access period after printing the results

To whom:
Data is available to researchers at academic, scientific and industrial institutions

Conditions:
Data for use in supplementary research, use in treatment and supplementary research

Where to obtain:
Neda Dehghan Ahmadabady
Kerman University of Medical Sciences
Ndeh197@gmail.com

How to obtain:
Send your written request to Ndeh197@gmail.com. Then, the request will be reviewed and the information will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Dehghan Ahmadabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Razi University of Medical Sciences Campus, Alavi Road</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76169-13555</zip>
        <telephone>+98 34 3377 8135</telephone>
        <email>Ndeh197@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Dehghan Ahmadabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Razi University of Medical Sciences Campus, Alavi Road</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76169-13555</zip>
        <telephone>+98 34 3377 8135</telephone>
        <email>Ndeh197@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not having any personality disorder with your doctor's diagnosis
Not having chronic respiratory disease
Lack of alcohol or other narcotics
Not having history of head trauma or seizure, stroke and brain tumor
There is no problem in the sense of smell
Not sensitized to plants
Not having a disturbance in consciousness
History of hemodialysis for at least 6 months
Not having a history of dementia, and Alzheimer, Parkinson, Huntington
Having physical and mental ability to answer questions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If you need to be admitted during the study
In case of allergy during the study
If more than three sessions during a month do not tend to get a healing scent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, only the usual care of the dialysis units and in fact training on adherence to the drug regimen is presented, and only the drug compliance questionnaire, retrospective memory and prospective memory are completed by these individuals.</i_keyword>
      <i_keyword>Intervention group: Lavender group: In this group, the samples will use lavender essential oil (2%) three times a week for the usual care (they will be manufactured by Kashan Barij Essen). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of lavender essential oil are poured into a gassus and placed within a distance of ten centimeters from the patient's nose. The lavender gas is put into a small 10cm container and the patient is asked to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.</i_keyword>
      <i_keyword>Intervention group: Routine group: In this group, the samples will use 100% essential oil (for the production of Barij Essen, Kashan) three times a week, for a period of one month. One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of daily essential oil are placed on a gas and placed at a distance of ten centimeters from the patient's nose. The daily gas is dipped in a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.</i_keyword>
      <i_keyword>Intervention group: Orange group: In this group, the samples will be used, in addition to receiving regular care, three times a week for orange essential oil (100%) (the construction of the Bariji Essential Oil Factory of Kashan). One hour after starting hemodialysis (to stabilize the patient's condition), 5 drops of orange essential oil are placed on a gas and placed within a distance of ten centimeters from the patient's nose. The orange gas is put into a small 10cm container and the patient is instructed to inhale it for 30 minutes. It should be noted that immediately after intervention (in other words at the end of four weeks) and one month after intervention, a retrospective-prospective memory questionnaire and drug compliance questionnaire are completed by referring to hemodialysis department. To control the essence of the essential oil, put the essential oils on a gas and put it in a small 10-centimeter container for the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of lavender essential oil on memory and drug compliance in patients undergoing hemodialysis. Timepoint: Three times a week for a month. Method of measurement: Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire.</prim_outcome>
      <prim_outcome>Effect of rosemary essential oil on memory and drug compliance in patients undergoing hemodialysis. Timepoint: Three times a week for a month. Method of measurement: Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire.</prim_outcome>
      <prim_outcome>The effect of orange essential oil on memory and drug compliance in patients undergoing hemodialysis. Timepoint: Three times a week for a month. Method of measurement: Demographic and field information questionnaire, Drug Abuse Measurement Questionnaire, and Retrospective and Prospective Memory Measurement Questionnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-03</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Razi University of Medical Sciences, Beginning of Seven Alavi Gardens Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
