<?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>IRCT201208053081N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-25</date_registration>
      <primary_sponsor>Vice Chancellor For Research Loreastan University Of Medical Sciences</primary_sponsor>
      <public_title>The effect of  birth ball  and supportive method  on  labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of  birth ball   and supportive method on  labor pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>labor pain in active phase.</hc_freetext>
      <i_freetext>Intervention 1: In control group receive routine care and standard care without any intervention. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period. Intervention 2: Birth ball ntervention1: In birth ball group during three phases of cervical dilatation during labor to parturient 30 minutes sitting on birth ball 90 degrees pelvic to rocking moves left and right forward and hind ward. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period. Intervention 3: In support group to help the researcher during three phases of cervical dilatation by talking with psychological support will associated him for 30 minutes. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.</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>Parvin Asti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 1620 0140</telephone>
        <email>Asti_P@yahoo.com, Asti.p@Lums.ac.ir,</email>
        <affiliation>Lorestan University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Asti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 1620 0140</telephone>
        <email>Asti_par@yahoo.com   , Asti.p@lums.ac.ir</email>
        <affiliation>Lorestan University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: A person's consent for entry into the study; participated serving an eight sessions classes; physiological childbirth preparation; aged between 35-18;gestational age 42-37;primiparous; Presentations cephalic; singleton pregnancy; dilation 3 -4 cm; low-risk pregnancies; Exclusion criteria: Drug addiction; use of sedative and narcotic drugs; use of oxytocin to induce and augmentations of labor; the delivery of mental and medical obstetric disorders;CPD and the lack of progress.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>000-099</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy,childbrith and the pureperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group receive routine care and standard care without any intervention. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.</i_keyword>
      <i_keyword>Birth ball ntervention1: In birth ball group during three phases of cervical dilatation during labor to parturient 30 minutes sitting on birth ball 90 degrees pelvic to rocking moves left and right forward and hind ward. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.</i_keyword>
      <i_keyword>In support group to help the researcher during three phases of cervical dilatation by talking with psychological support will associated him for 30 minutes. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of labor pain. Timepoint: During cervix dilatations of 3-4, 5-7 and 8-10 centimeter, one time. Method of measurement: Visual Analog Scale and Present  Behavioral Intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of the phase active of labor. Timepoint: From cervical dilatation (3-4 Cm) to full dilatation. Method of measurement: labor time in hour.</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 Loreastan University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-14</approval_date>
        <contact_name>Country Committee for Medical Research Ethics</contact_name>
        <contact_address>Azadi St.,  Avesta Park Ave, Vice Chancellor for Research and Technology of the Ministry of Health, Fifth Floor Teharan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
