<?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>IRCT20171026037015N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-16</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>ٍThe Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers,</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27502</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: -.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers.</hc_freetext>
      <i_freetext>Intervention 1: The first Intervention group: Includes nulliparous pregnant mothers who passed routine pregnancy training. These training was conduct in eight weekly sessions and in accordance with the Ministry of Health protocol in group of 6 to12 pregnant mothers and includes the first session;  anatomy and physiology,  common complaints during pregnancy, second session; nutrition, third session; personal and mental health, fourth session; Signs of danger during pregnancy, fifth session; planning for delivery, cesarean or normal vaginal delivery, Solutions for reducing labor pain, Sixth Session; Maternal actions during childbirth , The seventh session; postpartum care and the eighth session; neonatal care and lactation. Each session consisted of 45 minutes of theory training, half an hour of exercise and 20 minutes of relaxation. Intervention 2: The second Intervention group: Includes nulliparous pregnant women who passed  cognitive behavioral training.These training was conduct  In eight weekly sessions, according to the Wijma 2017 protocol, pregnant mothers will be trained in groups of 5 to 7 mothers. Content of the first session: the first trimester of natural pregnancy, welcome, an overview of the rules and regulations of group counseling sessions, meet the members together, ask questions, the uncertainties and concerns of members about group meetings and consultants guidance, assessing the goals and expectations of members from counseling sessions, an attempt to create a safe and consensual space with the aim of accelerating the change process. Content of the second session: natural pregnancy In the second trimester, teaching ABCDE concepts in cognitive behavioral approach, listing fears, concerns and anxieties associated with pregnancy and childbirth, identifying methods to deal with anxiety situations and thoughts, feelings and behaviors associated with it, provides psychological information about the nature of anxiety and fear and how to Body responses when anxiety occurs. The content of the third session includes: natural third trimester pregnancy, self control exercises (scanning your thoughts, feelings and behaviors in anxious situations), respiratory retraining training, relaxation training (calming). The content of the fourth and fifth sessions includes: natural delivery, relief of pain, preparation and start of the training of controlling the anxious thoughts through Cognitive Restructuring Techniques (Such as: disaster, thinking stopping technique, and pay attention) and positive self reflection. The content of the sixth session includes: the first and second stages of normal delivery, internal exposure, with the aim of consciously and deliberately creating anxiety emotions to reject false evaluations of these feelings and silence of anxiety response. Contents of the 7th session: labor and natural delivery, critical situations of internal exposure with the aim of  consciously and deliberately creating anxious emotions to reject false evaluations of these feelings and silence of anxiety response. Content of the 8th session: labor and natural delivery of the third stage, identification of factors that may  be barrier the effectiveness of treatment, solutions for the relapse of fear, concerns and anxieties, describing individuals from their expectations of labor and delivery imminent, summarizing the content presented in the meetings. Intervention 3: Control group: The pregnant Women who do not participate in any educational classes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Disagreement between project partners</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Houri Alijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town</address>
        <city>Gorgan city</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3242 1660</telephone>
        <email>alijani@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes Sadat Borghei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4913815739</zip>
        <telephone>+98 17 3245 6900</telephone>
        <email>borghei@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>low risk Nulliparous Women
ages between 18 to 35 years old
Gestational age between 20 to 28 weeks
The desire to participate in the study
Score questionnaire 55 and above</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participate in psychological training classes</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>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first Intervention group: Includes nulliparous pregnant mothers who passed routine pregnancy training. These training was conduct in eight weekly sessions and in accordance with the Ministry of Health protocol in group of 6 to12 pregnant mothers and includes the first session;  anatomy and physiology,  common complaints during pregnancy, second session; nutrition, third session; personal and mental health, fourth session; Signs of danger during pregnancy, fifth session; planning for delivery, cesarean or normal vaginal delivery, Solutions for reducing labor pain, Sixth Session; Maternal actions during childbirth , The seventh session; postpartum care and the eighth session; neonatal care and lactation. Each session consisted of 45 minutes of theory training, half an hour of exercise and 20 minutes of relaxation.</i_keyword>
      <i_keyword>The second Intervention group: Includes nulliparous pregnant women who passed  cognitive behavioral training.These training was conduct  In eight weekly sessions, according to the Wijma 2017 protocol, pregnant mothers will be trained in groups of 5 to 7 mothers. Content of the first session: the first trimester of natural pregnancy, welcome, an overview of the rules and regulations of group counseling sessions, meet the members together, ask questions, the uncertainties and concerns of members about group meetings and consultants guidance, assessing the goals and expectations of members from counseling sessions, an attempt to create a safe and consensual space with the aim of accelerating the change process. Content of the second session: natural pregnancy In the second trimester, teaching ABCDE concepts in cognitive behavioral approach, listing fears, concerns and anxieties associated with pregnancy and childbirth, identifying methods to deal with anxiety situations and thoughts, feelings and behaviors associated with it, provides psychological information about the nature of anxiety and fear and how to Body responses when anxiety occurs. The content of the third session includes: natural third trimester pregnancy, self control exercises (scanning your thoughts, feelings and behaviors in anxious situations), respiratory retraining training, relaxation training (calming). The content of the fourth and fifth sessions includes: natural delivery, relief of pain, preparation and start of the training of controlling the anxious thoughts through Cognitive Restructuring Techniques (Such as: disaster, thinking stopping technique, and pay attention) and positive self reflection. The content of the sixth session includes: the first and second stages of normal delivery, internal exposure, with the aim of consciously and deliberately creating anxiety emotions to reject false evaluations of these feelings and silence of anxiety response. Contents of the 7th session: labor and natural delivery, critical situations of internal exposure with the aim of  consciously and deliberately creating anxious emotions to reject false evaluations of these feelings and silence of anxiety response. Content of the 8th session: labor and natural delivery of the third stage, identification of factors that may  be barrier the effectiveness of treatment, solutions for the relapse of fear, concerns and anxieties, describing individuals from their expectations of labor and delivery imminent, summarizing the content presented in the meetings.</i_keyword>
      <i_keyword>Control group: The pregnant Women who do not participate in any educational classes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of birth. Timepoint: Before of the intervention and 8 week after intervention. Method of measurement: WDEQ (Wijma Delivery Expectancy, Experience 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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-17</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Hirkan Blvd.,The Shast kola Ave., Deputy of research and technology., Golestan University of Medical Sciences.,  Gorgan Town Gorgan city Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
