<?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>IRCT138812193527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-13</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>The Effect of Acupressure on Labor Pain and Labor Outcome</public_title>
      <acronym></acronym>
      <scientific_title>The Study of Effect of Acupressure in SP6 on Labor Pain and Labor Outcome in Women During Labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>131</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor Pain and Delivery out come.</hc_freetext>
      <i_freetext>Intervention 1: pressure at SP6:30-minute pressureas follows: At first, a 2-minute pressure was applied in a way that a pleasant feeling of pain would be experienced by the subject. Care was taken to keep the degree of paleness of the nail at a constant level and the subject pleased with the pressure. Subsequently, regardless of contractions, one minute of pressure followed by a minute's rest was applied intermittently until the pressure time equaled an overall 30 minutes. It took one hour to perform this technique every time. Intervention 2: Touch at SP-6:in the same  schedule touch at SP-6 was applied in the first control group. Intervention 3: The second control group (common care) was only encouraged to breathe deeply and stay relax.</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>Minoor Lamyian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, nasr bridj, jalal al ahmad high way, tarbiat modares university</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 3809</telephone>
        <email>lamyianm@modares.ac.ir pmfsamadi@yahoo.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>parisa samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan branch, Eslamic Azad University, infront of taleghani hospital, abadan, khoozestan, iran</address>
        <city>abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 63 1222 8017</telephone>
        <email>pmfsamadi@yahoo.com&#13;
lamyianm@modares.ac.ir</email>
        <affiliation>Abadan branch, Eslamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18 to 35 years-old pregnant women; 38-42 weeks gestational age; parity of 1 or 2; no use of psycho-therapeutics nor labor induction medications prescribed by physician or midwife; no use of chemical or natural pain killers prior to the study; cervical dilatation of 3-5cm; BMI less than 29; devoid of any medical or obstetrical problems such as uterine myomas, pre-cancerous lesions, cephalopelvic disproportion, infertility or surgical operation on uterus or cervix, placenta previa, placental abruption, poly- or oligohydramnios, erythroblastosis fetalis, preeclampsia, gestational diabetes, decreased fetal movements; no use of tobacco (e.g., smoking, hubble bubble, drugs) or alcohol and no verbal, auditory, or mental problems.&#13;
  Exclusion criteria: lack of consent;               &#13;
oxytocin dose in excess of routine requirements and any sign of fetal distress such as a heart rate of over 160 or less than 110beats/min, late decelerations, thick meconium staining and prolonged or precipitate labor, newborn weighing less than 2500 or more than 4000 grams</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80-O84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>pressure at SP6:30-minute pressureas follows: At first, a 2-minute pressure was applied in a way that a pleasant feeling of pain would be experienced by the subject. Care was taken to keep the degree of paleness of the nail at a constant level and the subject pleased with the pressure. Subsequently, regardless of contractions, one minute of pressure followed by a minute's rest was applied intermittently until the pressure time equaled an overall 30 minutes. It took one hour to perform this technique every time.</i_keyword>
      <i_keyword>Touch at SP-6:in the same  schedule touch at SP-6 was applied in the first control group</i_keyword>
      <i_keyword>The second control group (common care) was only encouraged to breathe deeply and stay relax.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor Pain intensity. Timepoint: Before intervention, immediately following 2 minutes' intervention, after 30 minutes' intervention and 30 minutes post-intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Labor duration. Timepoint: Labor duration was documented in two time periods ,first time period, dilatation of 3cm to complete cervical dilatation; and second time period, from complete cervical dilatation to delivery time. Method of measurement: Cervical dilatation by vaginal exam and at cm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before intervention , after 30 minutes' intervention and 30 minutes post-intervention. Method of measurement: FAS.</sec_outcome>
      <sec_outcome>Analgesic taking. Timepoint: Before and through intervention they did not take any analgesic. Method of measurement: Amount of analgesic taking.</sec_outcome>
      <sec_outcome>Delivery type. Timepoint: After labour. Method of measurement: Registration in questionnaire.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-02-17</approval_date>
        <contact_name>Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Jalal Ale Ahmad Highway,Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
