<?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>IRCT2015031021020N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-10</date_registration>
      <primary_sponsor>Research Chancellor of Alborz University of Medical Sciences</primary_sponsor>
      <public_title>Compared the effect of heat and cold therapy on outcomes of labor</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of heat and cold therapy on outcomes of labor and satisfaction in primigravida women referred to the Kamali hospital in Alborz 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18530</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>normal vaginal delivery.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group: In The heat therapy group will be used warm water bag during contraction in the first stage of labor for at least 60 minutes on the lower back, abdomen area and under abdomen and in second stage will be used warm water bag for at least 4 minutes on the perineum. Intervention 2: In the second intervention group: In The cold therapy group will be used cold ice bag on the lower back, abdomen and under abdomen for 10 minutes once every 30 minutes during the first stage and and in second stage will be used cold ice bag on the perineum for 5 minutes every 15 minutes. Intervention 3: In the control group: This group will be recived routine care of labor ward and a midwife will be with woman all the time.</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>Zahra Mehdizadeh Tourzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, First Golestan Street, Eshteraki Avenue, Above the Takhti Park, Baghestan Blv</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31485/56</zip>
        <telephone>+98 26 3433 6008</telephone>
        <email>z_mehdizadeh_t@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mehdizadeh Tourzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, First Golestan Street, Eshteraki Avenue, Above the Takhti Park, Baghestan Blv</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31485/56</zip>
        <telephone>+98 26 3433 6008</telephone>
        <email>z_mehdizadeh_t@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria consisted of nulliparous women in the age range between 18-35 years, women in the active phase of labor (3-4 cm dilatation), cephalic presentation, gestational age between 37-41 weeks and being a singleton fetus without preset abnormalities.&#13;
Exclusion criteria included pre diagnosed of psychological and anatomical disorders, pre diagnosed of  chronic diseases, indications for cesarean section, abnormal fetal heart patterns, history of chronic pelvic pain, history of infertility in women or spouse, any problem created during labor, women's unwillingness to continue to heat or cold therapy, women who live apart from their spouses, use of narcotics in about 8 hours before of active labor and skin diseases, including any injury, inflammation and eczema in the region of using hot-cold therapy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group: In The heat therapy group will be used warm water bag during contraction in the first stage of labor for at least 60 minutes on the lower back, abdomen area and under abdomen and in second stage will be used warm water bag for at least 4 minutes on the perineum.</i_keyword>
      <i_keyword>In the second intervention group: In The cold therapy group will be used cold ice bag on the lower back, abdomen and under abdomen for 10 minutes once every 30 minutes during the first stage and and in second stage will be used cold ice bag on the perineum for 5 minutes every 15 minutes.</i_keyword>
      <i_keyword>In the control group: This group will be recived routine care of labor ward and a midwife will be with woman all the time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain. Timepoint: First and second stage of labor. Method of measurement: McGill Pain linear scale.</prim_outcome>
      <prim_outcome>Duration of  stages of labor. Timepoint: First, second and third stages of labor. Method of measurement: Digital clock.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's satisfaction. Timepoint: Postpartum. Method of measurement: 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>Research Chancellor of Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-02</approval_date>
        <contact_name>Research Chancellor of Alborz University of Medical Sciences</contact_name>
        <contact_address>Ninth Floor, Dara Building, North Yasaman, East Pune Avenue, 45 meter of Golshahr Karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
