<?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>IRCT20160821029446N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of psychological immunization strategy on fear of childbirth</public_title>
      <acronym></acronym>
      <scientific_title>The effect of psychological immunization strategy on fear of childbirth in  childparents  primiparous woman</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60360</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Assignment of samples to intervention (A) and control (B) groups (32 people in each group) will be done using blocks with size of 4. In this way, 6 possible modes will be considered using a table of random numbers. These 6 modes are written on 6 separate cards and the cards will be placed in a black bag (for concealment) . A card will be issued for 16 times to finally get 64 letters written as the sample size. The intervention group will be the group that will receive psychological immunization training sessions in addition to childbirth preparation classes, and the control group will be the group that will receive only childbirth preparation classes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:the intervention group will be given Ten sessions of mental immunization training. These sessions will be held two one-hour sessions per week (five weeks in total) from the twentieth week of pregnancy. Psychological immunization sessions will be conducted in the form of individual interviews (In the form of talking in class), Perform relaxation techniques, Examining mothers' opinions and fears about childbirth, Examination of environmental and internal stressors and Factors that cause fear in mothers, Answer all these symptoms, Teaching relaxation techniques,Teaching coping techniques against stress, Giving correct information to mothers, Assessing mothers' sense of adequacy and  teaching them the necessary points, Expressing mothers' feelings and fears and etc. So far in Iran,  the education with this technique has not been performed on mothers. These interventions are designed to evaluate the effectiveness of this technique in the primiparous child parent woman. None of this is covered in childbirth preparation classes. Intervention 2: Control group: No action is taken for members of the control group. These people receive routine pregnancy care. Once before the intervention in the intervention group and once after the training sessions in the intervention group, the Vijma questionnaire will be filled out by the control group at the same time as the intervention group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there isnt  more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>najmeh taghiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, tehran university of medical science, tohid sq, Twhran, Iran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1499733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>najm9276@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Damghanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Tehran University of Medical sciences, Tohid sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733172</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>maryam_damghanian@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Be literate
Smartphone access
20 weeks  gestational age
Singleton
Absence of pregnancy complications such as bleeding and preeclampsia
primiparous
mother age less than 18 years
Participate in childbirth preparation classes</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of infertility
having chronic diseases
having known mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.232</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fear of other medical care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:the intervention group will be given Ten sessions of mental immunization training. These sessions will be held two one-hour sessions per week (five weeks in total) from the twentieth week of pregnancy. Psychological immunization sessions will be conducted in the form of individual interviews (In the form of talking in class), Perform relaxation techniques, Examining mothers' opinions and fears about childbirth, Examination of environmental and internal stressors and Factors that cause fear in mothers, Answer all these symptoms, Teaching relaxation techniques,Teaching coping techniques against stress, Giving correct information to mothers, Assessing mothers' sense of adequacy and  teaching them the necessary points, Expressing mothers' feelings and fears and etc. So far in Iran,  the education with this technique has not been performed on mothers. These interventions are designed to evaluate the effectiveness of this technique in the primiparous child parent woman. None of this is covered in childbirth preparation classes.</i_keyword>
      <i_keyword>Control group: No action is taken for members of the control group. These people receive routine pregnancy care. Once before the intervention in the intervention group and once after the training sessions in the intervention group, the Vijma questionnaire will be filled out by the control group at the same time as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth score in Vijma questionnaire. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Vijama Maternity Fear / Expectation Questionnaire Version A.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-04</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid square,Dr. Mirkhani Street (eastern nosrat) tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
