<?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>IRCT201103015948N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Islamic Azad University of Karaj branch</primary_sponsor>
      <public_title>The effect of foot reflexology on labor outcome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on anxiety, pain and outcomes of labor in primiparus woman referred to the Karaj hospital in 2011</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6425</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 outcomes.</hc_freetext>
      <i_freetext>Intervention 1: For intervention group: Gentle massage of all surface of plantar and some points  upon of feet using thumb and pointing fingers then continuous pressure on solar network, pituitary and uterus points in the feet for 40 minutes (20 minutes per foot) at 3-4 cm dilatation. The point of solar network is located on the border of one-third upper and middle feet (in part that wrinkle is formed during the foot plantar flexion) along the second and third finger. Pituitary point is located in the middle of toe. Uterine point also is located into the deep area between internal ankles and heel of feet. Intervention 2: For control group: Receiving  routine care of  labor ward and massages of other parts of foot except three main points that mentioned, for 40 minutes (20 minutes per foot) at 3-4 cm dilatation.</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>Soheila Moghimi Hanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Nursing &amp; midwifery faculty</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7720 4224</telephone>
        <email>soheila.moghimi@kiau.ac.ir;somoghimi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Moghimi Hanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Nursing &amp; midwifery faculty</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7720 4224</telephone>
        <email>soheila.moghimi@kiau.ac.ir; somoghimi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Women with singleton pregnancies and fetal with cephalic presentation, gestational age 37-41 weeks, without active psychiatric disorders and anxiety on personality according to Beck and Spielberger questionnaires,  without mental retardation, blindness and deafness, absence of fever, seizures, thrombosis, renal or gallbladder stones, foot disease, swelling, ulcer, trauma and fractures in the foot, not using the anti-anxiety medications and methods of complementary medicine during the previous week. &#13;
&#13;
Exclusion criteria: Use of any drug or method of analgesia and anesthesia, induction of labor with Oxytocin, abnormal fetal heart patterns, presence of any special medical condition (e.g. chronic diseases) and nature of taking any drug, women with a history of abortion, gestational hypertension, presence of any abnormal bleeding from placental abruption or placenta previa, polyhydroamnious, oligohydroamnious and intrauterine growth restriction that proved by ultrasound method, passing more than 12 hours from the time of rupture of membrane.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For intervention group: Gentle massage of all surface of plantar and some points  upon of feet using thumb and pointing fingers then continuous pressure on solar network, pituitary and uterus points in the feet for 40 minutes (20 minutes per foot) at 3-4 cm dilatation. The point of solar network is located on the border of one-third upper and middle feet (in part that wrinkle is formed during the foot plantar flexion) along the second and third finger. Pituitary point is located in the middle of toe. Uterine point also is located into the deep area between internal ankles and heel of feet.</i_keyword>
      <i_keyword>For control group: Receiving  routine care of  labor ward and massages of other parts of foot except three main points that mentioned, for 40 minutes (20 minutes per foot) at 3-4 cm dilatation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain intensity. Timepoint: Before intervention in 3-4cm cervical dilatation and immediately, half, one and two hours after the intervention. Method of measurement: McGill pain questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: Before intervention in 3-4cm cervical dilatation and immediately after the intervention. Method of measurement: Spielberger anxiety inventory.</prim_outcome>
      <prim_outcome>Duration of the first stage of labor. Timepoint: One time the start of labor until complete effacement and cervical dilatation. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
      <prim_outcome>Duration of the second stage of labor. Timepoint: One time from full dilatation of cervix to departure of baby. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
      <prim_outcome>Duration of the third stage of labor. Timepoint: One time from departure of baby to complete withdrawal of placenta. Method of measurement: According to minutes using the standard digital clock.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Type of delivery. Timepoint: One time after departure of baby. Method of measurement: Observed as a vaginal delivery, instrumental delivery and cesarean section.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Observation and examination.</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, Islamic Azad University of Karaj branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad university Karj barnch</contact_name>
        <contact_address>Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Mailbox: 31485-313 Karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
