<?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>IRCT20180206038637N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-17</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of acupressure on nausea and vomiting of pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effect of pressure on the KID21( Youmen) and P6 (Neiguan) points on the severity of nausea and vomiting pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Acupressure is preferred over drug therapy for treating NVP (1). The most effective and practical point in acupressure for treating nausea and vomiting is Neiguan P6. This point is approximately three finger breadths (4 cm) above the first transverse crease on the hand wrist between the flexor carpi radials tendons. P6 stimulation has been reported to reduce NVP in many controlled clinical trials (2).Another point used to treat NVP based on scientific resources is KID21 or Youmen or the Hidden Gate. It is 6 Cun above the navel and 0.5 Cun symmetrically from the sides of the middle line of the abdomen. Simulating this point helps improve NVP. In controlled clinical trials, the stimulation of KID21 has reduced NVP (3).Acupressure is preferred over drug therapy for treating NVP (1). The most effective and practical point in acupressure for treating nausea and vomiting is Neiguan P6. This point is approximately three finger breadths (4 cm) above the first transverse crease on the hand wrist between the flexor carpi radials tendons. P6 stimulation has been reported to reduce NVP in many controlled clinical trials (2).Another point used to treat NVP based on scientific resources is KID21 or Youmen or the Hidden Gate. It is 6 Cun above the navel and 0.5 Cun symmetrically from the sides of the middle line of the abdomen. Simulating this point helps improve NVP. In controlled clinical trials, the stimulation of KID21 has reduced NVP (3).1. Nguyen P, Einarson A. Managing nausea and vomiting of pregnancy with pharmacological and nonpharmacological treatments. Women's health (London, England). 2006; 2(5):753-60.2. Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. Journal of pain and symptom management. 2011; 42(4):589-603.3. Naeimi Rad M, Lamyian M, Heshmat R, Jaafarabadi MA, Yazdani S. A Randomized Clinical Trial of the Efficacy of KID21 Point (Youmen) Acupressure on Nausea and Vomiting of Pregnancy. Iran Red Crescent Med J. 2012;14 (11):697-701, Randomization description: A total of 80 pregnant women with nausea and vomiting were selected and, usined a block randomization method, assigned into two intervention groups, Blinding description: The Patient is not aware of the control and Case group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nausea and Vomiting in Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Pressure on Kid21 (acupressure) that is 6 Cun above the navel and 0.5 Cun both sides of the midline is symmetrical. Intervention 2: Intervention group 2: Pressure on P6 (acupressure) that is 3 Cun above the China wrist between the two tendons on the palm of the hand above the long palmar and bending radius.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university Of medical seinces, University square , Babol</address>
        <city>babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45745-47176</zip>
        <telephone>+98 11 3223 8301</telephone>
        <email>galeshi_m@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university Of medical seinces, University square , Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-41367</zip>
        <telephone>+98 11 3223 8301</telephone>
        <email>galeshi_m@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-35
single pregnancy
first trimester of pregnancy
presence of moderate to severe nausea and vomiting
Normal electrolyte
willing to participate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>unwanted pregnancy
gastrointestinal diseases
cigarette smoking
presence of ketonuria</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Excessive vomiting in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Pressure on Kid21 (acupressure) that is 6 Cun above the navel and 0.5 Cun both sides of the midline is symmetrical.</i_keyword>
      <i_keyword>Intervention group 2: Pressure on P6 (acupressure) that is 3 Cun above the China wrist between the two tendons on the palm of the hand above the long palmar and bending radius</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: Daily. Method of measurement: Visual Analogue 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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-20</approval_date>
        <contact_name>کمیته اخلاق پزشکی علوم پزشکی بابل</contact_name>
        <contact_address>Babol Univercity of Medical Sciences,Ganjafrooz street Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
