<?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>IRCT20190210042672N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-09</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of emotion regulation educations' effect on fear of childbirth in primigravida women</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of emotion regulation educations' effect on fear of childbirth in primigravida women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38068</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Grass Exercise Therapy Initially, Grass's Modeling Excitement (8 sessions, two sessions per week and each session for 120 minutes in groups of 6-12 people who met during the first familiarization session) Communicating with each other, expressing the main and subordinate goals of the group, expressing the framework and rules of the participant in the group, expressing the logic and the stages of intervention, starting the relationship between the leader of the group, discussing the members about the sub-goals and the collective, the second meeting of the choice of position-goal , Emotional education, Third-session selection of target-position selection, assessment of the degree of emotional vulnerability, assessment of the emotional level of the members, the meeting. E-mail: Modifying Location-Target, Creating Change in Emotion-Driven Position, Fifth Session, Attention-Target Exercise, Teaching Skills, Sixth Session, Cognitive Evaluation-Objective, Modifying Cognitive Assessments, Seventh-Tentative Adjustment-Target, Modifying Consequences of Behavior and Physiological excitement, Eighth Assessment and Application-Purpose, Re-evaluation and Planning for the Application of Training) are taught by the researcher. Then, the difference in fear of delivery with the CAQ questionnaire is measured in the pre-test and post-test phase and compared with each other. Intervention 2: Control group: There is no intervention. The difference in fear of delivery is measured by the CAQ questionnaire on pre-test and post-test phases and compared with each other.</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 After the meeting with the members of the research team, we will publish the research team if it is appropriate</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>fatemeh bayenat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3242 8056</telephone>
        <email>f.bayenat@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asieh Sadat Baniaghilآسیه سادات بنی عقیل</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3242 8056</telephone>
        <email>a_baniaghil@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be single
Her pregnancy is low risk.
According to her pregnant mother, she and her husband have not consumed drugs, psychotropic substances and alcohol in the last two months.
You do not have a history of infertility
Ask your pregnancy.
Minimum reading and writing education.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Until the end of the study, they intend to migrate from Gorgan.
His wife and wife suffer from a known psychiatric illness, taking psychiatric medications or physical illnesses (cancers) and chronic illness over the past two months.
Have a degree in medical sciences, psychology, or counseling.
Have a history of infertility.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Grass Exercise Therapy Initially, Grass's Modeling Excitement (8 sessions, two sessions per week and each session for 120 minutes in groups of 6-12 people who met during the first familiarization session) Communicating with each other, expressing the main and subordinate goals of the group, expressing the framework and rules of the participant in the group, expressing the logic and the stages of intervention, starting the relationship between the leader of the group, discussing the members about the sub-goals and the collective, the second meeting of the choice of position-goal , Emotional education, Third-session selection of target-position selection, assessment of the degree of emotional vulnerability, assessment of the emotional level of the members, the meeting. E-mail: Modifying Location-Target, Creating Change in Emotion-Driven Position, Fifth Session, Attention-Target Exercise, Teaching Skills, Sixth Session, Cognitive Evaluation-Objective, Modifying Cognitive Assessments, Seventh-Tentative Adjustment-Target, Modifying Consequences of Behavior and Physiological excitement, Eighth Assessment and Application-Purpose, Re-evaluation and Planning for the Application of Training) are taught by the researcher. Then, the difference in fear of delivery with the CAQ questionnaire is measured in the pre-test and post-test phase and compared with each other.</i_keyword>
      <i_keyword>Control group: There is no intervention. The difference in fear of delivery is measured by the CAQ questionnaire on pre-test and post-test phases and compared with each other.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth in the CAQ delivery fear questionnaire. Timepoint: Before the intervention begins and immediately after the intervention is completed. Method of measurement: CAQ delivery fear 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>2018-10-09</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
