<?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>IRCT201307047494N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-21</date_registration>
      <primary_sponsor>Vice Chancellor for research Mazandaran University of Medical Sciences.</primary_sponsor>
      <public_title>The effect of aromatherapy with Lavender essence  on pain from the fistula needle in patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with Lavender essence  on  pain from the fistula needle in patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7957</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: On the first day of the study (before the intervention), the pain from the fistula needle will be  measured and recorded.&#13;
 Experimental group: 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 at a concentration of 10% for 3 consecutive times (once for each hemodialysis). 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 with one in- ten proportion and 10% compound is produced. A total of 3 interventions during three sessions of dialysis will be performed. Thus, a cotton ball soaked with 3 drops of lavender essence with concentration of 10% will be put at a distance of 10 cm and the patient  will be asked to breathe slowly for 5 minutes . Fistula is then punctured. Needles used are the same for all patients taken from Soha Company with the number of BNO: P 948115 A MFG. In each intervention, the VAS pain scale is measured after aromatherapy. Intervention 2: Control group: Patients in the control group will be treated by the above method under aromatherapy with placebo. The placebo is produced by Barij Essence Company and include a base combination of an aromatherapy without lavender. For the preparation of the compound, one drop of the lavender essence is poured into the base solution which is sweet almond oil to make it dilute and cause it to have the same smell without having its properties.</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>Dr Mohamad Ali Heydari Gorji</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>4816715793</zip>
        <telephone>+98 15 1326 1245</telephone>
        <email>heydarigorji@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Science</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>4816715793</zip>
        <telephone>+98 15 1326 1245</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran  University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient including major criteria; 3 times a week dialysis;  being over 18; alertness and ability to communicate and having a good sense of smell. &#13;
Patient eligibility major criteria; candidate for a transplant; pregnancy; record of allergies; chronic respiratory diseases; using analgesic in 3 hours and drug addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>130 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49</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>On the first day of the study (before the intervention), the pain from the fistula needle will be  measured and recorded.&#13;
 Experimental group: 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 at a concentration of 10% for 3 consecutive times (once for each hemodialysis). 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 with one in- ten proportion and 10% compound is produced. A total of 3 interventions during three sessions of dialysis will be performed. Thus, a cotton ball soaked with 3 drops of lavender essence with concentration of 10% will be put at a distance of 10 cm and the patient  will be asked to breathe slowly for 5 minutes . Fistula is then punctured. Needles used are the same for all patients taken from Soha Company with the number of BNO: P 948115 A MFG. In each intervention, the VAS pain scale is measured after aromatherapy.</i_keyword>
      <i_keyword>Control group: Patients in the control group will be treated by the above method under aromatherapy with placebo. The placebo is produced by Barij Essence Company and include a base combination of an aromatherapy without lavender. For the preparation of the compound, one drop of the lavender essence is poured into the base solution which is sweet almond oil to make it dilute and cause it to have the same smell without having its properties.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The pain from the fistula needle. Timepoint: Before intervention and after 3 interventions. Method of measurement: Visual Pain Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergic to Lavender. Timepoint: To 6 days after the first intervention. Method of measurement: Side effects of the drug and the patient's questions.</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>2013-05-29</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>
