<?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>IRCT20180407039223N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Combined Massage of Hugo and Saninjiao Points on the labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Saninjiao acupressure with combined Sp6 , LI4 acupressure  on labor pain intensity  in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: If the patient uses analgesics or oxytocin, they will be excluded, Randomization description: Considering that in our study, there are three control groups, Saninjiao point acupressure  and a combination  massage,  block  sampling (six )will be used. Previous envelopes are considered by the methodologist (in the sixth block) and in Each of these envelopes has a letter A or B or C. A total of 105 envelopes will be available to qualified participants. At the time of entering the research environment, choose one of the pre-prepared envelopes for the patient himself and determine which of the groups A, B, C will be placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor pain intensity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Saninjiao acupressure ،An example of a non-pharmacological method is acupressure, where acupuncture points are stimulated by hands, fingers, thumbs, or small beads. This method acts according to the gate control theory where burning, massaging, and scratching can stimulate the large fibers responsible for transmitting nerve impulses to the spinal cord. A sustained stimulation can keep the gates of pain transmission closed, which may result in decreased pain. On the other hand, the stimulation of acupressure points using heat, needles, or pressure causes the release of endorphins.Acupressure was applied by placing index and middle finger  of both hands on both legs at the same time from the beginning to the end of the contraction. The researcher massage the acupressure points so that the patient feet  will numb .At the end of the contraction, acupressure was stopped .This process continued for 20 minutes only during the uterine contractions (the number of contractions varied based on each patient. During the acupressure procedure, uterine contractions and fetal heart rate will monitored. Intervention 2: Intervention group: Combined  Hugo and Saninjao acupressure. An example of a non-pharmacological method is acupressure, where acupuncture points are stimulated by hands, fingers, thumbs, or small beads. This method acts according to the gate control theory where burning, massaging, and scratching can stimulate the large fibers responsible for transmitting nerve impulses to the spinal cord. A sustained stimulation can keep the gates of pain transmission closed, which may result in decreased pain. On the other hand, the stimulation of acupressure points using heat, needles, or pressure causes the release of endorphins.Acupressure was applied by placing index and middle finger  of both hands on both legs at the same time from the beginning to the end of the contraction. At the end of the contraction, pressure was gradually reduced and acupressure was stopped during the resting phase . with the beginning the contraction the Hugo point on both hands is pressed in the same way during contractions, and again the Saninjiao point is pressed on both legs during the contractions, and again the Hugo point in both hands is the same . The order is squeezed. This process continued for 20 minutes only during the uterine contractions (the number of contractions varied based on each patient).During the acupressure procedure, uterine contractions and fetal heart rate will monitored. Intervention 3: Control group:   Saninjiao Point touch, With  the beginning to the end of the contraction the touch of the Saninjiao point occurs . At the end of the contraction,  touch was stopped during the resting phase and this continues for up to 20 minutes only during contractions. During the touch  procedure, uterine contractions and fetal heart rate will monitored.</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 Results will be published as articles.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۳۷۷۳۹۵۵</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>leilabagheri1352@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۳۷۷۳۹۵۵</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>leilabagheri1352@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Singleton pregnancy
Gestational age 37-42 weeks
Intact fetal membrane
Having at least  4 cm of dilatation
Have at least 3 contractions in 10 minutes
Cephalic presentation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High  risk pregnancy
Poor Ob history
Vaginal bleeding
Large baby
Cephalopelvic disporportion
145 cm height and lower
Having lesion at Saninjiao and Hugo points
Having any problems leading to the mother's inability to communicate</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Saninjiao acupressure ،An example of a non-pharmacological method is acupressure, where acupuncture points are stimulated by hands, fingers, thumbs, or small beads. This method acts according to the gate control theory where burning, massaging, and scratching can stimulate the large fibers responsible for transmitting nerve impulses to the spinal cord. A sustained stimulation can keep the gates of pain transmission closed, which may result in decreased pain. On the other hand, the stimulation of acupressure points using heat, needles, or pressure causes the release of endorphins.Acupressure was applied by placing index and middle finger  of both hands on both legs at the same time from the beginning to the end of the contraction. The researcher massage the acupressure points so that the patient feet  will numb .At the end of the contraction, acupressure was stopped .This process continued for 20 minutes only during the uterine contractions (the number of contractions varied based on each patient. During the acupressure procedure, uterine contractions and fetal heart rate will monitored.</i_keyword>
      <i_keyword>Intervention group: Combined  Hugo and Saninjao acupressure. An example of a non-pharmacological method is acupressure, where acupuncture points are stimulated by hands, fingers, thumbs, or small beads. This method acts according to the gate control theory where burning, massaging, and scratching can stimulate the large fibers responsible for transmitting nerve impulses to the spinal cord. A sustained stimulation can keep the gates of pain transmission closed, which may result in decreased pain. On the other hand, the stimulation of acupressure points using heat, needles, or pressure causes the release of endorphins.Acupressure was applied by placing index and middle finger  of both hands on both legs at the same time from the beginning to the end of the contraction. At the end of the contraction, pressure was gradually reduced and acupressure was stopped during the resting phase . with the beginning the contraction the Hugo point on both hands is pressed in the same way during contractions, and again the Saninjiao point is pressed on both legs during the contractions, and again the Hugo point in both hands is the same . The order is squeezed. This process continued for 20 minutes only during the uterine contractions (the number of contractions varied based on each patient).During the acupressure procedure, uterine contractions and fetal heart rate will monitored.</i_keyword>
      <i_keyword>Control group:   Saninjiao Point touch, With  the beginning to the end of the contraction the touch of the Saninjiao point occurs . At the end of the contraction,  touch was stopped during the resting phase and this continues for up to 20 minutes only during contractions. During the touch  procedure, uterine contractions and fetal heart rate will monitored.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity score  on VASA scale. Timepoint: Before the intervention, immediately, one hour and two hours after the intervention and in the second stage of labor. Method of measurement: Visual Analogue 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-20</approval_date>
        <contact_name>Ethics committee of shahroud University of Medical Sciences</contact_name>
        <contact_address>Hafte Tir Square shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
