<?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>IRCT201109136582N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-03-13</date_registration>
      <primary_sponsor>Tabriz university of medical sciences-research principal</primary_sponsor>
      <public_title>Comparison of the efficacy of Massage therapy and Breathing Techniques on Pain, physiologic responses to the labor Pain and delivery’s process and out coms in Tabriz</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Massage therapy and Breathing Techniques on Pain, physiologic responses to the labor Pain and delivery’s processand out coms  amoung Mothers admitied to Alzahra hospital in Tabriz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7036</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>labor pain-Pelvic and perineal pain.</hc_freetext>
      <i_freetext>Intervention 1: cervical Dilatation4&amp;8cm&#13;
Breathing 1 , Massage1        INTERVENTION. Intervention 2: The causes of dividing Breathing &amp; massage groups to (B1,2),(M1,2) was that each group has control group in all dilatations therefore the B1 samples did breathing techniques in 4,8 dilatations (case) and the samples of B2 group did not use breathing techniques in that dilatations and became control group. &#13;
The B2 samples did breathing techniques in 6,10 dilatations (case) and the samples of B1 group did not use breathing techniques in that dilatations and became control group.&#13;
 The M1 samples take massage in 4,8 dilatations (case) and the samples of M2 group did not take massage in that dilatations and became control group. &#13;
The M2 samples take massage in 6,10 dilatation (case) and the samples of M1 group did not take massage in that dilatations and became control group. Intervention 3: Cervical dilatation 6 &amp; 10 cm &#13;
Breathing1and Massage1 are control. Intervention 4: Cervical dilatation 4 &amp; 8 cm Breathing2 and Massage2 are control. Intervention 5: Cervical dilatation 6 &amp; 10 cm, &#13;
intervention,&#13;
     Breathing2,&#13;
Massage2.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, shariaty street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>nursung &amp;midwifery faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion: -primigravidas who expected to have normal childbirth &#13;
and have 20-35 years old, single fetus with 36≤gestational age and without any physical disease(such as kinds of paralyse ) that can affect the research&#13;
exclusion: &#13;
-the  sampels asking for pharmacologic methods of pain relief&#13;
- adminstration of oxytosin or other drugs</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>024-025-R1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Categories O24.- and O25 include the listed conditions even if they occur during childbirth or the puerperium.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>cervical Dilatation4&amp;8cm&#13;
Breathing 1 , Massage1        INTERVENTION</i_keyword>
      <i_keyword>The causes of dividing Breathing &amp; massage groups to (B1,2),(M1,2) was that each group has control group in all dilatations therefore the B1 samples did breathing techniques in 4,8 dilatations (case) and the samples of B2 group did not use breathing techniques in that dilatations and became control group. &#13;
The B2 samples did breathing techniques in 6,10 dilatations (case) and the samples of B1 group did not use breathing techniques in that dilatations and became control group.&#13;
 The M1 samples take massage in 4,8 dilatations (case) and the samples of M2 group did not take massage in that dilatations and became control group. &#13;
The M2 samples take massage in 6,10 dilatation (case) and the samples of M1 group did not take massage in that dilatations and became control group.</i_keyword>
      <i_keyword>Cervical dilatation 6 &amp; 10 cm &#13;
Breathing1and Massage1 are control</i_keyword>
      <i_keyword>Cervical dilatation 4 &amp; 8 cm Breathing2 and Massage2 are control</i_keyword>
      <i_keyword>Cervical dilatation 6 &amp; 10 cm, &#13;
intervention,&#13;
     Breathing2,&#13;
Massage2</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor Pain intensity. Timepoint: first &amp; second stage of labor. Method of measurement: NRS (Numerical rating scale).</prim_outcome>
      <prim_outcome>Physiologic responses to the labor Pain ( pals rate, blood pressure &amp;body temperature). Timepoint: first &amp; second stage of labor. Method of measurement: Pals rate counting for one minute,one blood pressure instrument,termometr.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Labor process. Timepoint: first &amp; second stage of labor. Method of measurement: partogram.</sec_outcome>
      <sec_outcome>Kind of labor. Timepoint: end of first &amp; second stages of labor. Method of measurement: observation &amp; writting it.</sec_outcome>
      <sec_outcome>Infants APGAR. Timepoint: first &amp; fifth minute after birth. Method of measurement: standard table of APGAR score.</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>Tabriz university of medical sciences-research principal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2006-08-13</approval_date>
        <contact_name>Tabriz university of medical scienses</contact_name>
        <contact_address>University of Medical Scienses and Health Services,Daneshgah street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
