<?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>IRCT20200404046943N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-09</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of face-to-face training and mobile phone training on fear of childbirth</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of peer-based education using mobile phone and face-to-face education on fear of childbirth in primigravia  women in comprehensive health centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the study groups, Random allocation will be made with blocking methods. First, all possible combinations of AABBCC blocks will be listed, one code will assign to each of them, and then 11 codes will be select randomly. They will be Blind to ensure that there is no bias. After selecting them, go to the blocks corresponding to each code, and then according to the available combinations, people will enter the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Face to face training: 6 training sessions held once a week, and the time of face-to-face training will be 90 minutes. The first sessions Content is Introducing peers and getting acquainted with each other, educating clients about the reproductive system and reproduction of women and the names and functions of some organs involved in childbirth, common complaints during pregnancy, and how to deal with them. Stretching exercises, summarizing the first session and Assignment, and get feedback (feedback on mobile education will be self-reported by mothers). The second session's content is a group discussion on anxiety and stress-related to pregnancy and ways to deal with it, including relaxation methods and breathing techniques, the importance of prenatal care, danger symptoms, personal health, final summary, and assigning feedback. The third session's content is a Review of homework, and a brief review of the previous session, self-control of emotions, nutrition and maintenance of a proper diet, childbirth and pain relief methods, gaining the support of a spouse or a loved one, final summary, Assignment, and provide feedback. The fourth session's content is a Review of homework and a brief review of the previous session, training to introduce common mental errors in childbirth, the importance of vaginal delivery, final summary, homework assignment, and feedback. The fifth sessions Content is a Review of homework and a brief review of the previous session, description of labor stages, labor and delivery process, familiarity with hospital routine, application of distracting behavioral techniques, deep breathing, muscle relaxation, expression of peer experiences of labor and labor stages, summary, Assignment and provides feedback. The sixth session's content is a review of homework and a brief review of the previous session. It teaches people how to use methods to reduce pain and stretch and to breathing exercises to people, teaching breastfeeding, and caring for the baby. Intervention 2: Intervention group2: Intervention group via mobile phone Educational content in WhatsApp program in 4 groups of 6-5 people through group chat, sending an audio file and educational video by peers to mothers and questions and answers with group members and discussing training presentations Based on the experience of delivery, the counterparts will be presented. The sessions will be weekly for 90 minutes. Intervention 3: Control group،The routine care will receive to the control group during pregnancy, and no intervention will accrue.</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 There is not much information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The first floor of Sadra building, sub-street 1, Khayyam street, Meshginshahr city, Ardabil province, Iran</address>
        <city>Meshginshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5661844518</zip>
        <telephone>+98 45 3252 8948</telephone>
        <email>Za.sa.rostame@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roqia Bayrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nazloo Campus,Urmia University of Medical Sciences,UrmiaWest Azerbaijan Province,Iran</address>
        <city>Orumieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>0098 44327549614</telephone>
        <email>rozabayrami@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing Persian literacy
Age range 18 to 35 years
Singleton
primigravia  women
Pregnancy age 24 to 32 weeks
No history of infertility
Lack of stressful events in the last 6 months
Lack of medical indications for cesarean section
Lack of mental illness
Having a mobile phone with Android operating system, the ability to connect to the Internet, the ability to use WhatsApp
Get a score of 85 or higher on the Vijma Questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any disease added to the pregnancy that requires a cesarean section for the mother
Having any complications during pregnancy such as high blood pressure during pregnancy, decompression, fetal death, premature rupture of the bladder, preterm delivery
Mental illness
No contact information</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Face to face training: 6 training sessions held once a week, and the time of face-to-face training will be 90 minutes. The first sessions Content is Introducing peers and getting acquainted with each other, educating clients about the reproductive system and reproduction of women and the names and functions of some organs involved in childbirth, common complaints during pregnancy, and how to deal with them. Stretching exercises, summarizing the first session and Assignment, and get feedback (feedback on mobile education will be self-reported by mothers). The second session's content is a group discussion on anxiety and stress-related to pregnancy and ways to deal with it, including relaxation methods and breathing techniques, the importance of prenatal care, danger symptoms, personal health, final summary, and assigning feedback. The third session's content is a Review of homework, and a brief review of the previous session, self-control of emotions, nutrition and maintenance of a proper diet, childbirth and pain relief methods, gaining the support of a spouse or a loved one, final summary, Assignment, and provide feedback. The fourth session's content is a Review of homework and a brief review of the previous session, training to introduce common mental errors in childbirth, the importance of vaginal delivery, final summary, homework assignment, and feedback. The fifth sessions Content is a Review of homework and a brief review of the previous session, description of labor stages, labor and delivery process, familiarity with hospital routine, application of distracting behavioral techniques, deep breathing, muscle relaxation, expression of peer experiences of labor and labor stages, summary, Assignment and provides feedback. The sixth session's content is a review of homework and a brief review of the previous session. It teaches people how to use methods to reduce pain and stretch and to breathing exercises to people, teaching breastfeeding, and caring for the baby.</i_keyword>
      <i_keyword>Intervention group2: Intervention group via mobile phone Educational content in WhatsApp program in 4 groups of 6-5 people through group chat, sending an audio file and educational video by peers to mothers and questions and answers with group members and discussing training presentations Based on the experience of delivery, the counterparts will be presented. The sessions will be weekly for 90 minutes.</i_keyword>
      <i_keyword>Control group،The routine care will receive to the control group during pregnancy, and no intervention will accrue.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Childbirth Fear Score in the Vijma Birth Fear Questionnaire. Timepoint: Pre-test (before the start of the intervention), post-test (immediately after the intervention), follow-up (one month after the intervention). Method of measurement: General score obtained from the Vijma A Fear of Childbirth Questionnaire.</prim_outcome>
      <prim_outcome>Pregnancy Anxiety Score in Shortened Questionnaire Pregnancy Anxiety Wendenberg. Timepoint: Pre-test (before the start of the intervention), post-test (immediately after the intervention), follow-up (one month after the intervention). Method of measurement: The total score obtained from the abbreviated questionnaire of Wendenberg.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of childbirth. Timepoint: Follow-up test (one month after the last intervention session). Method of measurement: The overall score obtained from the Vijma Birth Fear Questionnaire.</sec_outcome>
      <sec_outcome>Pregnancy Anxiety. Timepoint: Follow-up test (one month after the last intervention session). Method of measurement: The overall score obtained in the shortened Wondenberg Pregnancy Anxiety Questionnaire.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-17</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Khayyam Street Meshginshahr Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
