<?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>IRCT20190703044082N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-04</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of acupressure on the amount and intensity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of acupressure on the amount and intensity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>111</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To randomly assign the participants to the acupressure, placebo and control groups, the names of the three groups will be written on paper and taken randomly, and the order of sampling of the groups will be determined. 20 blocks of 6 will be used for random allocation of samples in three groups. In this way, the letter A will be considered for the acupressure group, the letter B for the placebo group, and the letter C for the control group. on pieces of paper, and we will pick them randomly. Then, according to the possible order of sampling, it will start, Blinding description: Patients are blinded to the allocation of which group they will be placed in. That is, children and their families are unaware of whether they have been placed in the acupressure, placebo and control groups. In addition, the person who collected the data is blinded to the assignment of individuals to groups.</study_design>
      <phase>1</phase>
      <hc_freetext>leukemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acupressure wristband group: First, the P6 point on the left hand is closed on the inner side of the forearm, in the cavity between the bones of the forearm, with a distance of three fingers above the fold of the wrist, then the wristband is fixed on the P6 point with a push button for 30 minutes. to be able to press the mentioned point. This intervention is performed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes. Intervention 2: Placebo group: wristband without push button is used. For this purpose, point P6 is determined and the wristband is closed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes for people in this group. Intervention 3: Control group: Control group: Wristbands are not used for this group. The level and severity of nausea, vomiting and comfort level of children before chemotherapy (T0), at the end of the first day (T1), at the end of the second day (T2) and at the end of the day. The third (T3) is asked and recorded by the researcher's assistant at 12:00 noon and night.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme  Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>mohammadifateme47@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>mohammadifateme47@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children 6-12 years old with leukaemia Under chemotherapy Treated with a fixed dose of chemotherapy Not having digestive diseases</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lymphoid leukemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acupressure wristband group: First, the P6 point on the left hand is closed on the inner side of the forearm, in the cavity between the bones of the forearm, with a distance of three fingers above the fold of the wrist, then the wristband is fixed on the P6 point with a push button for 30 minutes. to be able to press the mentioned point. This intervention is performed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes.</i_keyword>
      <i_keyword>Placebo group: wristband without push button is used. For this purpose, point P6 is determined and the wristband is closed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes for people in this group.</i_keyword>
      <i_keyword>Control group: Control group: Wristbands are not used for this group. The level and severity of nausea, vomiting and comfort level of children before chemotherapy (T0), at the end of the first day (T1), at the end of the second day (T2) and at the end of the day. The third (T3) is asked and recorded by the researcher's assistant at 12:00 noon and night.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency and severity of nausea and vomiting. Timepoint: Before chemotherapy and at the end of the first, second and third day after chemotherapy. Method of measurement: Rhodes Nausea and Vomiting Index adapted for children by parents.</prim_outcome>
      <prim_outcome>Patient comfort. Timepoint: Before chemotherapy and at the end of the first, second and third day after chemotherapy. Method of measurement: visual analog scale (VAS).</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-01</approval_date>
        <contact_name>Research ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
