<?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>IRCT2015083123837N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Studying the impacts of the combination of effective methods compared with doula on reducing anxiety and pain of mothers in childbirth in the Jam Tohid Hospital in 2015</public_title>
      <acronym></acronym>
      <scientific_title>Studying the impacts of the combination of effective methods compared with doula on reducing anxiety and pain of mothers in childbirth in the Jam Tohid Hospital in 2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Single spontaneous delivery.</hc_freetext>
      <i_freetext>Intervention 1: Control: Having Doula during delivery. Intervention 2: Intervention: During pregnancy, in coordination with the mother-friendly hospital heads, several pregnancy and childbirth preparation classes (6 sessions with about 105 minutes within a week of each other will be held by the by the researcher and his colleagues which are about training neuromuscular exercises, relaxation, proper breathing, concentration exercises and also the appropriate positions in childbirth.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Background and objective: Childbirth is a matter of great moment in woman’s life committed to her memory permanently which is inevitably influenced by emotional, social and psychological stress. Severe labor pain may cause long term emotional imbalance and impaired mental health and thus have a negative effect on the relationship between the mother and baby. On the other hand, appearance of neuroticism is very common during childbirth and anxiety and fear with no reason are the most common disorder that appear as irritability and a feeling of concern and stress. This study aimed to assess the anxiety and pain level of nulliparous women giving birth using physiological methods (without doula support) during labor as opposed to doula supported women at Jam Touhid hospital in 2015.&lt;br /&gt;&#13;
Materials and Methods: This was an interventional study conducted in 2015. 150 women referring to Jam Touhid hospital, affiliated to Iran-Bushehr University of Medical Sciences, were randomly assigned to either an intervention group (with doula support) or a control group (with no doula support). The intrapartum, postpartum and hidden anxiety was measured using Spielberger standard questionnaire used for assessing anxiety. The labor pain rate was evaluated by using MC Gill questionnaire. Data analysis was carried out in SPSS 18.0 using t-test. &lt;br /&gt;&#13;
Findings: Results showed that the average rate of obvious anxiety during labor was 57.769.57 in physiological delivery (without doula) and 48.049.61 in doula supported delivery. The difference between mean scores of obvious anxiety during labor was significant. The mean anxiety of the control group (who didn’t receive doula support) was higher (P-Value = 0.000). In addition, the mean score of labor pain was 41.724.46 in the physiological delivery and 36.524.46 in the doula supported delivery. &lt;br /&gt;&#13;
The difference between the mean labor pain scores was statistically significant. It was higher in the physiological delivery (41.72) compared to the doula supported delivery (36.52) (P-Value = 0.000). &lt;br /&gt;&#13;
Conclusion: The results of the study showed that doula’s presence has positive significant effects on labor pain and anxiety reduction and doula supported mothers reported considerably lower pain and anxiety compared to those experiencing physiological delivery (without doula). So, the increased use of doula in hospitals all over the country is recommended. </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>Dr. Ramin Ravangard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3234 0774</telephone>
        <email>ravangard@sums.ac.ir; ra_ravangard@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramin Ravangard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3234 0774</telephone>
        <email>ravangard@sums.ac.ir; ra_ravangard@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:&#13;
- Being Iranian; &#13;
- Age between 16 and 44; &#13;
- First pregnancy;&#13;
- At least 32 weeks of gestational age;&#13;
- Lack of pregnancy complications;&#13;
- Having a live fetus;&#13;
- Having a single fetus;&#13;
- Start spontaneous contractions;&#13;
- Intact sac;&#13;
- No pelvic restraint;&#13;
- No history of hospitalization due to complications of pregnancy;&#13;
- No history of diseases such as thyroid, and diseases related to the kidney, heart, liver, diabetes, and lack of psychiatric diseases.&#13;
Exclusion Criteria:&#13;
- Fetal macrosomia;&#13;
- The studied pregnant women's unwillingness to continue their cooperation with the researcher and participation in the intervention;&#13;
- Fetal anomaly detection during the study;&#13;
- Onset of labor before or after term;&#13;
- Fetal distress;&#13;
- Premature rupture of membranes;&#13;
- The use of pain relievers;&#13;
- The occurrence of any complications during labor and delivery and the need for cesarean section.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>44 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>Single spontaneous delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control: Having Doula during delivery</i_keyword>
      <i_keyword>Intervention: During pregnancy, in coordination with the mother-friendly hospital heads, several pregnancy and childbirth preparation classes (6 sessions with about 105 minutes within a week of each other will be held by the by the researcher and his colleagues which are about training neuromuscular exercises, relaxation, proper breathing, concentration exercises and also the appropriate positions in childbirth.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: During delivery. Method of measurement: McGill Pain Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Befor and during delivery. Method of measurement: Spielberger State-Trait Anxiety Inventory 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-19</approval_date>
        <contact_name>The Ethics Committee in Biomedical Research, Shiraz University of Medical Sciences, Cose: EC UMS S I</contact_name>
        <contact_address>Iran Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
