<?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>IRCT20240205060907N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of acupressure and eucalyptus inhalation on headache in hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of acupressure and eucalyptus inhalation on headache intensity in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, simple random allocation using random number table method is used. For this purpose, people are numbered and registered on paper from 1 to 33 in the order of their entry into the study. The direction of reading the numbers is chosen by the researcher from left to right. Then the researcher randomly places his hand on one of the numbers with his eyes closed and moves in a predetermined direction; The first 11 numbers to the acupressure group, 11 Next number to the Eucalyptus inhalation group, And the rest are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Headache in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acupressure is performed for the first test group. In this study, acupressure applied pressure on the HeGu points between the first and second bones of the palm, Yin Tang between the eyebrows, Taiyang on the external corners of the eyes, and GB20 (Gallbladder20) on the vertebrae. The first is neck. The amount of pressure applied should be such that the person feels a little heat and pain in the pressured area. The duration of the intervention for each patient is 3 sessions in three consecutive visits. At the beginning of dialysis (the first 20 minutes), each point is pressed for 1 minute, in the form of pressure for 8 seconds, followed by 2 seconds of rest, a total of 4 minutes for each patient in each session. Intervention 2: Intervention group: Aromatherapy is performed for the second test group. This group is treated with aromatic eucalyptus extract, 1 ml of which is placed on a 2/4 gas and inhaled for 5 minutes from a distance of 30 cm at the beginning of dialysis (first 20 minutes). Intervention 3: Control group: No action is taken in the control group.</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 For the sake of trust</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mahdi, Narimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No. 117, 31 St., Afsariyeh, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1784899314</zip>
        <telephone>+98 21 3364 6233</telephone>
        <email>narimani.mahdii77@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam, Radmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Islamic Azad University, Isfahan Khorasgan Branch, University Blvd, Arghwaniyeh, East Gey Street , Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-39998</zip>
        <telephone>35002117</telephone>
        <email>maryam.radmehr3132@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who complain of headache according to their own statement and by entering in the file
Absence of swelling and numbness in HeGu, Taiyang, Yin Tang, GB21 (Gall Bladder) points in test group one.
Not using acupressure for any purpose in all three groups at the same time as this study
Absence of any wound, scratch, infection and deformity in HeGu, Taiyang, Yin Tang, GB21 (Gall Bladder) points in test group one.
Absence of olfactory disorder in the second test group
Having informed consent to participate in the study
No advanced neuropathy for all three groups
Having a minimum score of 1 pain in the head area based on the pain measurement scale​</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of using Acupressure and Eucalyptus inhalation or any Aromatherapy to treat Headaches in the past​
Frequent and Chronic use of Narcotic Drugs
Drug Addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for care involving renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acupressure is performed for the first test group. In this study, acupressure applied pressure on the HeGu points between the first and second bones of the palm, Yin Tang between the eyebrows, Taiyang on the external corners of the eyes, and GB20 (Gallbladder20) on the vertebrae. The first is neck. The amount of pressure applied should be such that the person feels a little heat and pain in the pressured area. The duration of the intervention for each patient is 3 sessions in three consecutive visits. At the beginning of dialysis (the first 20 minutes), each point is pressed for 1 minute, in the form of pressure for 8 seconds, followed by 2 seconds of rest, a total of 4 minutes for each patient in each session.</i_keyword>
      <i_keyword>Intervention group: Aromatherapy is performed for the second test group. This group is treated with aromatic eucalyptus extract, 1 ml of which is placed on a 2/4 gas and inhaled for 5 minutes from a distance of 30 cm at the beginning of dialysis (first 20 minutes).</i_keyword>
      <i_keyword>Control group: No action is taken in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Headache score in numerical rating scale. Timepoint: At the beginning of the study (before the start of the study), immediately after the intervention. Method of measurement: Numeric Rating Scale.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-04</approval_date>
        <contact_name>Ethics Committees of Islamic Azad university-Isfahan(Khorasga) branch</contact_name>
        <contact_address>Isfahan Islamic Azad University, Isfahan Khorasgan Branch, University Blvd, Arghwaniyeh, East Gey Street , Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
