<?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>IRCT20190805044446N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-03</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of heat therapy on pain intensity and duration of labor</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of infrared belt with hot water bag on pain intensity and duration of first stage of labor in primipara women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>162</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42297</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a three-group study, Randomization description: Block of six, which is done by computer.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Birth pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Infrared Belt: Two cycles of 20 minutes intervention by infrared belt in first stage of labor for 40 minutes total. Intervention 2: Intervention group 2: Hot water bag,two cycles of 20 minutes intervention by hot water bag in first stage of labor for 40 minutes total. Intervention 3: Control group: Third group Control group: Routine care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>erfanian fateme</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctoral crossroads</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>--</zip>
        <telephone>+98 51 4263 5735</telephone>
        <email>Erfanianf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>erfanian fateme</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctoral crossroads</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>--</zip>
        <telephone>+98 51 4263 5735</telephone>
        <email>Erfanianf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian.• The age of delivery is 18-35 years.• Be literate.• Sign a written consent form.• be primiparous.• Be monotonous.• Show fetal head peak.• The fetal head fits the mother's pelvis.Gestational age is 38 weeks to 42 weeks based on the first day of the last menstrual period or ultrasound of the first trimester of pregnancy.Estimated weight of the fetus using Johnson's law or ultrasound after 32 weeks will be between 25,000 to 4,000 grams.Spontaneous labor has begun (4-5 cm dilatation with at least two contractions of 20 or 30 seconds and more within 10 minutes).• The intensity of labor pain should be greater than 3 on the visual pain scale (10 cm ruler).Do not have speech-auditory or dialect problems that impede communication with the researcher.• Do not have drug and alcohol and tobacco addiction.• Has not had a psychiatric or psychologist experience, medication or hospitalization due to mental illness during the past year.• Has not been under major stress for the past 6 months.• Not be affected by medical conditions.• Do not have midwifery problems.• Has no history of surgery on the uterus or cervix.• Have not used the medicine prescribed by your doctor, midwife or herbal medication for the past 24 hours to start labor pain.• The mother's oral temperature should not be equal to or greater than 38 ° C.• Do not have severe anxiety.• Do not have scars, scratches, burns, eczema or lumbar lesions that prevent heat treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother to discontinue continuing research.Emergency caesarean section is indicated for any reason.Use oxytocin to induce labor or accelerate labor.Use narcotics, Entonox, numbness.• There are signs of fetal distress.• Observe any abnormal cases, such as hypertonic contractions or rapid tibial systolic dysfunction and disturbances in the vital signs of the mother and others• Observe any possible side effects of the infrared belt (skin burns, increased maternal body temperature, abnormal fetal heart sound, abnormal uterine contractions, maternal intolerance to the infrared belt or hot water bag)• Mother's intolerance of infrared belt or hot water bag•	Other cases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>--</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>--</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Infrared Belt: Two cycles of 20 minutes intervention by infrared belt in first stage of labor for 40 minutes total</i_keyword>
      <i_keyword>Intervention group 2: Hot water bag,two cycles of 20 minutes intervention by hot water bag in first stage of labor for 40 minutes total</i_keyword>
      <i_keyword>Control group: Third group Control group: Routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain with shortened McGill questionnaire. Timepoint: At the beginning of the study, after the first intervention, after the second intervention, at the end of the first phase. Method of measurement: shortened McGill questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-13</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad School of Nursing and Midwifery, doktora squar, Mashhad . Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
