<?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>IRCT201304298717N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on prevention of nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on severity of nausea and vomiting during hemodialysis in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: This study is single blinded so that patients do not know anything about the type of the intervention (acupressure or placebo). Also in this study, placebo is used, so that when the Sea-Band button is placed on the opposite site of P6 (Nei guan) on the back of the forearm, it has the placebo role. When the Sea-Band button is placed on the point P6 (Nei guan) in the inner surface of the forearm, it has the acupressure role.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention (Routine care): In the control group patients receive routine care, that is consisted of normal saline (200 ml) after nausea and vomiting. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale. Intervention 2: The second intervention (use of acupressure): In the intervention group, 10 minutes before inserting hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on the P6 point (Nei guan) on the inner surface of the forearm, about 2 inches (three fingers width) above the Internal groove of wrist. The Sea-Band remains during hemodialysis and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale. Intervention 3: The third intervention (use of placebo): In the intervention group, using placebo, 10 minutes before entering the hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on opposite of P6 point (Nei guan) on the back of the forearm. The Sea-Band during hemodialysis remains and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.</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. Mohammad Reza Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514743365</zip>
        <telephone>+98 23 1445 3365</telephone>
        <email>asgari5000@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ِDr. Mohammad Reza Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514743365</zip>
        <telephone>+98 23 1445 3365</telephone>
        <email>asgari5000@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are: (1) being alert; (2) not taking antiemetic drugs at least six hours before hemodialysis; (3) beginning of hemodialysis at least three months before the study; (4) being over 20 years old; (5) having no skin problem such as allergies and ulcers at the Sea-Band site; (6) being depended on three cycles of hemodialysis per week. &#13;
Exclusion criteria are: (1) having a low level of consciousness, (2) being transfered to other centers during the study (3) requiring emergency hemodialysis; (4) taking a long journey by car just before hemodialysis ;(5) having acute gastrointestinal illnesses; (6) having pain or severe anxiety; (7) having motion sickness.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention (Routine care): In the control group patients receive routine care, that is consisted of normal saline (200 ml) after nausea and vomiting. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.</i_keyword>
      <i_keyword>The second intervention (use of acupressure): In the intervention group, 10 minutes before inserting hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on the P6 point (Nei guan) on the inner surface of the forearm, about 2 inches (three fingers width) above the Internal groove of wrist. The Sea-Band remains during hemodialysis and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.</i_keyword>
      <i_keyword>The third intervention (use of placebo): In the intervention group, using placebo, 10 minutes before entering the hemodialysis needles, the Sea-Band is closed on patients’ wrists so that its button is placed on opposite of P6 point (Nei guan) on the back of the forearm. The Sea-Band during hemodialysis remains and is removed at the end of hemodialysis just before removing hemodialysis needles. After removing hemodialysis needles and dressing of vascular access site, a nurse measures the severity of nausea and vomiting during hemodialysis by using verbal numerical rating scale (VNRS) and korttila vomiting severity scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of vomiting. Timepoint: At the end of hemodialysis, after removing hemodialysis needles and dressing of vascular access site. Method of measurement: korttila vomiting severity scale.</prim_outcome>
      <prim_outcome>Severity of nausea. Timepoint: At the end of hemodialysis, after removing hemodialysis needles and dressing of vascular access site. Method of measurement: Verbal Numeric Rating Scale (VNRS).</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>Vice chancellor for research, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics committee of semnan university of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Semnan, Semnan Province, Iran Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
