<?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>IRCT201311136807N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-27</date_registration>
      <primary_sponsor>Vice Chancellor for research of the international branch of Shahid Beheshti University of Medical Sc</primary_sponsor>
      <public_title>Comparing the effect of acupressure at SP6 point and foot reflexology on severity of labor pain and duration in the first stage of labor</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of acupressure at SP6 point and foot reflexology on severity of labor pain and duration in the first stage of labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization performs by the permutation blocking method.</study_design>
      <phase>2-3</phase>
      <hc_freetext>delivery.</hc_freetext>
      <i_freetext>Intervention 1: Acupressure group: in this group, the SP6 point (where is located in the four fingers above the medial malleouse at the posterior tibia) will be under pressure in two 30-minutes stages from 4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher. Intervention 2: Reflexology group: in this group uterine zone (located under the medial malleolus foot) and the solar plexus (in the superior and middle border line in the sole) will be under pressure in two 30-minutes stages from the start of  4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher. Intervention 3: Routine care group: in this group routine care will be done for samples. Also this group received a placebo point touch (dorsal region of foot along with third and fourth finger which is not any pathway meridians).</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>Mr Amir Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Obstetrics department, Valiasr Street, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>asa_akbari@yahoo.com</email>
        <affiliation>Obstetrics department of Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mrs Amir Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Obstetrics department, Valiasr Street, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>asa_akbari@yahoo.com</email>
        <affiliation>Shahid Beheshti Medical Sciences and Health University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: primigravid and second birth multigravid women; Iranian race; 18-35 years old; at least an elementary school education; singleton pregnancy; live fetus with cephalic presentation; women in the start of active phase of labor; the presence of regular uterine contractions (three contractions in 10 minutes); the gestational age of 37 to 42 weeks (the first day of the last menstrual period (LMP) or ultrasound under 12 weeks ); no history of infertility indication Caesarean section; to having a intact amniotic sac or to not past rupture of membranes for more than 12 hours; low risk pregnancy (absence of bleeding in the third trimester; placenta previa; abruption; intrautrine growth restriction) absence of the risk of chronic diseases such as: heart disease, pulmonary, hypertension, diabetes, according to the patient file; not suffering from skin diseases such as: eczema, skin infections and wart in legs; lack of any problems that may lead to the mother's inability to communicate (deafness, blindness); no history of acupressure and reflexology in the past.&#13;
Exclusion criteria: the client required a Caesarean delivery for any reason (abnormal fetal heart rate pattern; no breakthrough bleeding pregnancy; arrest of labor) mother's unwillingness to continue doing acupressure and or foot reflexology.</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>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Acupressure group: in this group, the SP6 point (where is located in the four fingers above the medial malleouse at the posterior tibia) will be under pressure in two 30-minutes stages from 4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher.</i_keyword>
      <i_keyword>Reflexology group: in this group uterine zone (located under the medial malleolus foot) and the solar plexus (in the superior and middle border line in the sole) will be under pressure in two 30-minutes stages from the start of  4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher.</i_keyword>
      <i_keyword>Routine care group: in this group routine care will be done for samples. Also this group received a placebo point touch (dorsal region of foot along with third and fourth finger which is not any pathway meridians).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Befor 4-5 and 7-8 cm cervical dilatation and 30 minutes after mentioned dilatation. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Duration of first stage of labor. Timepoint: From the beginning of 4 cm until 10 cm cervical dilatation. Method of measurement: Watch ecueped seconds counter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of second stage of labor. Timepoint: From 10 cm dilatation cervix to full expose of fetus. Method of measurement: Swiss Swatch watch.</sec_outcome>
      <sec_outcome>Duration of third stage of labor. Timepoint: From full expose of fetus to full expose of placenta. Method of measurement: Swiss Swatch watch.</sec_outcome>
      <sec_outcome>First and fifth minutes of apgar. Timepoint: One and five minutes after birth. Method of measurement: Standard Apgar Index.</sec_outcome>
      <sec_outcome>Method of delivery. Timepoint: After delivery. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Satisfactory of method of relief labor pain. Timepoint: After delivery. Method of measurement: Questioner.</sec_outcome>
      <sec_outcome>Amount of pain relief. Timepoint: After delivery. Method of measurement: Questioner.</sec_outcome>
      <sec_outcome>Tendency to use of pain relief method again. Timepoint: After delivery. Method of measurement: Questioner.</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>Vice Chancellor for research of the international branch of Shahid Beheshti University of Medical Sc</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-03</approval_date>
        <contact_name>Ethics committee of the International Branch of Shahid Beheshti University of Medical Sciences and H</contact_name>
        <contact_address>No19, Shahid Abbasspour Street, Valiasr Street,Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committee of the Iran University of Medical Sciences and Heath Services</contact_name>
        <contact_address>Hemmat freeway (beside Milad Tower), Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
