<?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>IRCT20241112063678N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-28</date_registration>
      <primary_sponsor>University of Baghdad</primary_sponsor>
      <public_title>Effect Aromatherapy in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Lavender, Peppermint and Rose Oil on Pain and Anxiety Associated with Arteriovenous Fistula Cannulation in Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research, Randomization description: The sampling method involves simple random sampling to obtain representative elements of populations. The sampling procedure includes a small colored ball containing three colors (white, black, green and red) and will give each patient the choice of one color. Each color represents one of three groups. White = control group. Black = lavender group. Green= peppermint group. Red = rose group.
This method aims to eliminate bias in intervention assignments, greatly growing the ability to generalize study findings. Additionally, since the number of participant's variation daily, simple random sampling confirm to be the most efficient method for sampling, Blinding description: The sampling procedure includes a small colored ball containing three colors (white, black, green and red) and will give each patient the choice of one color. Each color represents one of three groups. White = control group. Black = lavender group. Green= peppermint group. Red = rose group.
This method aims to eliminate bias in intervention assignments, greatly growing the ability to generalize study findings.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preparatory care for renal dialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the administration to application , two drops of lavender,peppermint and rose essential oisl was applied to the forearm region of participants in the group ( initial interview), and were test for any allergy sign such as erythema, rash, and swelling on the administrated region area. The essential oil that will be given to participations in group lavender,peppermint and rose are 100% pure. After pouring 200cc of boiling water into a bowl, five drops will be dripped into the bowl and patients will be inhalation at a distance of approximately 30 cm for five minutes. Patients will be completely covered with a cloth and advice to closed their eyes and deeply inhalation. Intervention 2: Control group: without any intervention.</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 will be the results of the VAS and STAIs that measures pain and anxiety level in both control and intervention group

When:
God Willing, once the article is published, the data will be available after 6 months of publication.
If the article will be published in a subscribed journal, the data will be available after one year
because of the policy of the subscribed journals.

To whom:
With academic nurses and any researcher who is interested in the data

Conditions:
the data could be used after getting the permission via email .Also, users need to acknowledge the owner

Where to obtain:
Users can ask for the data and the permission via email. Abdulrazaq Abdulrahman Khalid is the corresponding author. He will be in contact with whom ask for the data. His email is
abd.abd2302m@conursing.uobaghdad.edu.iq

How to obtain:
Users can ask for the data and the permission via email. Abdulrazaqz Abdulrahman Khalid is the corresponding author. He will be in contact with whom ask for the data. His email is
abd.abd2302m@conursing.uobaghdad.edu.iq

Comments:
none</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdulrazaq Abdulrahman Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AL-zubair</address>
        <city>AL-zubair</city>
        <country1>Iraq</country1>
        <zip>61001</zip>
        <telephone>+964 773 138 4575</telephone>
        <email>abd.abd2302m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdulrazaq Abdulrahman Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AL-zubair</address>
        <city>AL-zubair</city>
        <country1>Iraq</country1>
        <zip>61001</zip>
        <telephone>+964 773 138 4575</telephone>
        <email>abd.abd2302m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Their being at least 18 years old.
Agreeing to participate in study.
Undergoing conventional hemodialysis twice or more than times a week.
Obtaining a visual analog scale (VAS) mild pain score or higher during AVF insertion.
No allergy to aroma oils.
No diagnostic with chronic obstructive pulmonary diseases (COPD).
No loss in the sense of smell.
Healthy AVF access.
Speak Arabic.
fistula cannulation not exceed one year.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient within hepatic or as heart failure disease.
persistent bleeding.
panic disorder.
Not good function fistula.
Use analgesic drugs within two hours before hemodialysis procedures.
Pregnant woman.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preparatory care for renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the administration to application , two drops of lavender,peppermint and rose essential oisl was applied to the forearm region of participants in the group ( initial interview), and were test for any allergy sign such as erythema, rash, and swelling on the administrated region area. The essential oil that will be given to participations in group lavender,peppermint and rose are 100% pure. After pouring 200cc of boiling water into a bowl, five drops will be dripped into the bowl and patients will be inhalation at a distance of approximately 30 cm for five minutes. Patients will be completely covered with a cloth and advice to closed their eyes and deeply inhalation.</i_keyword>
      <i_keyword>Control group: without any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcomes variable is level pain and anxiety associated with arteriovenous fistula changed after inhalation oils. Timepoint: During intervention and 30 minutes after intervention. Method of measurement: Visual Analog Scale and The Arabic version of State and Trait Anxiety Invetory (STAI).</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>University of Baghdad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-28</approval_date>
        <contact_name>Ethics committee of University of Baghdad College of Nursing</contact_name>
        <contact_address>Bab almuadham ,Baghdad Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
