<?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>IRCT20100503003860N34</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-17</date_registration>
      <primary_sponsor>Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pressure on bile duct 21 on labor pain severity and length of delivery  in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>174</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29423</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The appointment of individuals in groups was randomized using the RANDOM ALLOCATION SOFTWARE FOR CLINICAL TRIAL software. Using this software, information about the sample number, the number of groups, the groups names will be taken into the data and output software, which includes the list of random groups of the groups, Blinding description: In this study, a full description of the research is given to the research units at first, and the patient is given written consent for participation in the study. Then Pregnant mothers are placed in separate rooms to avoid being aware of the intervention. In the control group only routine care is applied.</study_design>
      <phase>N/A</phase>
      <hc_freetext>labor pain.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured. Intervention 2: Intervention group 2: The second group is pressure on shame  point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured. Intervention 3: Control group: The third group is the control group. This group receives all routine care except for 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>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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamideh Torkiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>iranifarvahar@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gity Ozgoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>g.ozgoli@gmail.com</email>
        <affiliation>Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be primiparous
cephalic presentation
ability to read and write
18-35years
Gestational age 37-41 weeks and Singletonage
tendency to use analgesia
be in active phase</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Do not have to work with a researcher
Conditions lead to cesarean section
high risk pregnancies
skin disorders
chronic diseases
mental and anatomical disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured.</i_keyword>
      <i_keyword>Intervention group 2: The second group is pressure on shame  point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured</i_keyword>
      <i_keyword>Control group: The third group is the control group. This group receives all routine care except for intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: Before the intervention,Immediately after intervention, 30 minutes and 60 minutes after intervention. Method of measurement: Numerical rating scale.</prim_outcome>
      <prim_outcome>Length of Delivery. Timepoint: during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage. Method of measurement: minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mode of delivery. Timepoint: once-after delivery. Method of measurement: Questioner.</sec_outcome>
      <sec_outcome>Neonatal Apgar Score. Timepoint: 1 and 5 minute after birth. Method of measurement: check list.</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>Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
