<?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>IRCT20200610047717N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>effect of acupressure on severity of labor pain and duration of first stage of labor</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of acupressure at SP6 and SP8 points on severity of  labor pain and duration of first stage of labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random number functions will be used to randomize and assign individuals to groups. This is done by Excel software and a random number table. In this way, first in a column, the groups are entered as A, B, C and below. Because the number of samples in each group is set to 50 (including sample shedding), 150 to A, B, and C must be entered in the following order. In the opposite column, random numbers are generated using the RAND command. In the next step, using the SORT command, random numbers generated from small to large or vice versa are arranged, which changes the order of the groups. Using the new order, people are assigned to different groups. People are unaware of which group they belong to, Blinding description: The subjects will be explained that this is a study that will put pressure on one of the three points of interest. These points may or may not reduce the pain and length of the first stage of labor. People will be randomly placed in one of these three groups and pressure will be applied to the desired point. Patients understand acupressure but do not know the names of the points and which point is for intervention and which point is for control. They do not know the exact use of the points and only know that they belong to one of the three groups that receive acupressure at one of the three points and that the points can reduce labor pain and the length of labor or not.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Labor pain. Condition 2: The length of the first stage of labor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Compression at  SP6 points. Perform acupressure with thumbs and vertically at SP6 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-7 cm and 10-8 cm. Intervention 2: Intervention group: Compression medicine at SP8 points. Perform acupressure with thumbs and vertically at SP8 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-5 cm and 10-8 cm. Intervention 3: Control group: Compression  in control points. Perform acupressure with thumbs and vertically at the control points (2 cm lower and 1 cm back from the SP8 point) with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 7- 5 cm and 10-8 cm. It should be noted that according to the project's expert consultant, this point is neutral in terms of acupressure.</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 The work is not complete.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh Amir Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sedaliakbari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Amir Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sedaliakbari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 18-35
Have at least literacy
Spontaneous onset of labor pains and a desire to have a normal delivery
When hospitalized, dilate 3-4 cm.
According to the mother, they should not be addicted to drugs and tobacco.
ccording to the mother, they do not have family problems in the last 6 months and severe psychological crises such as the death of loved ones, migration, separation from their spouses, and so on.
According to the mother, they do not have chronic diseases (heart disease, lung disease, high blood pressure, diabetes, etc.).
Do not have high-risk pregnancies (gestational hypertension, gestational diabetes, placenta previa, decolman).
Do not suffer from skin disorders such as eczema and superficial skin infections, which are some of the limitations of acupressure.
The fetus should be single, alive, cephalic
There are no high-risk fetal criteria (fetal heart failure, decreased fetal movement, intrauterine growth restriction, polyhydramnios, and oligohydramnios known by ultrasound and amniotic sac rupture for more than 12 hours).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People who do not want to continue studying.
Examples that will require emergency cesarean section.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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: Compression at  SP6 points. Perform acupressure with thumbs and vertically at SP6 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-7 cm and 10-8 cm</i_keyword>
      <i_keyword>Intervention group: Compression medicine at SP8 points. Perform acupressure with thumbs and vertically at SP8 points with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 5-5 cm and 10-8 cm</i_keyword>
      <i_keyword>Control group: Compression  in control points. Perform acupressure with thumbs and vertically at the control points (2 cm lower and 1 cm back from the SP8 point) with the onset of contraction for 20 minutes continuously in each dilatation 3-4 cm and 7- 5 cm and 10-8 cm. It should be noted that according to the project's expert consultant, this point is neutral in terms of acupressure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain. Timepoint: before the intervention, Immediately, 15 minutes and 30 minutes after the intervention. Method of measurement: Numerical rating scale.</prim_outcome>
      <prim_outcome>The length of the first stage of labor. Timepoint: From dilatation 3 cm to 10 cm. Method of measurement: Timer( Seiko watch).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intensity of labor pain. Timepoint: Intensity of labor pain is measured in dilatations of 3-4 cm, 5-7 cm, 10-8 cm. These measurements are taken immediately, 15 minutes and 30 minutes after acupressure. Method of measurement: Pain measuring ruler (numerical rating scale).</sec_outcome>
      <sec_outcome>The length of the first stage of labor. Timepoint: The length of the first stage of labor is measured from dilatation 3-4 cm to 10 cm. Method of measurement: The length of the first stage of labor is measured according to the official national clock of the Seiko model.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-03</approval_date>
        <contact_name>Ethics Committee in Research, School of Pharmacy, Nursing and Midwifery, Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti School of Nursing and Midwifery., Opposite Shahid Rajaei Heart Hospital, Niayesh Intersection, Valiasr St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
