<?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>IRCT20210220050418N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey the effect of educational intervention using mobile application on fear of childbirth in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Survey the effect of educational intervention using mobile application on fear of childbirth in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54453</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: This study is a quasi-experimental intervention. In order to assign individuals in the intervention and control groups, one day clients are assigned to the experimental group and the next day clients are assigned to the control group. In other words, the members of the experimental group are selected from the eligible clients on even days of the week, and the members of the control group are selected from the eligible clients on the odd days of the week.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the implementation of the training program, version A of the Wijma Delivery Expectancy/Experience Questionnaire in both intervention and control groups will be completed by the research units and then the training software will be installed on the test group mobile phones and these people receive this training in addition to receiving routine prenatal care. It should be noted that the control group does not receive any intervention from the researcher and will only be under routine care during pregnancy. In order not to disrupt the research process, the control group will not be informed of the installation of software on the phone of the experimental group, and this is possible by selecting the members of the experimental and control groups on separate days and not colliding with each other. The use of software during the study period will be reminded once a week by sending a text message to the mothers of the experimental group by the researcher. In order to answer the mothers in case of problems or ambiguity and questions, the researcher's phone number will be provided to the mothers. At the end of the 8-week training period, at the first visit of the research units to the hospital for care (referral time will be planned by the researcher and coordinated with individuals), again, version A of the Wijma Delivery Expectancy/Experience Questionnaire will be provided to the research units of both test and control groups and will be completed by them in the presence of the researcher. The mothers of the test and control groups will be instructed to inform the researcher of the time of their delivery (whether normal delivery or cesarean section). Version B of  Wijma Delivery Expectancy/Experience Questionnaire will be provided to the study units after delivery by the researcher in person at the hospital where the delivery was completed. In this research, educational content including designing and compiling educational software by an experienced programming expert based on the explanation of the delivery process, methods of reducing labor pain, training different positions during labor and childbirth, stretching exercises, respiratory pattern, relaxation and massage. The educational content provided in the software will be taken from the book "Pregnancy and childbirth training" published by the Ministry of Health and Medical Education. This book includes 5 sections: pregnancy, childbirth, postpartum, baby care and stretching exercises, breathing pattern, relaxation and massage. The content will be extracted from the second part (childbirth) and the fifth part (stretching exercises, breathing pattern, relaxation and massage). Intervention 2: Control group: The control group does not receive any intervention from the researcher and will only be under routine care during pregnancy. In order not to disrupt the research process, the control group will not be informed of the installation of software on the phone of the experimental group, and this is possible by selecting the members of the experimental and control groups on separate days and not colliding 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Main and general data

When:
1 year

To whom:
Faculty Members of Shahid Beheshti Faculty of Midwifery and Nursing, Rasht

Conditions:
In order to verify the accuracy of the information and with a written and approved request from the research deputy of Shahid Beheshti Faculty of Nursing and Midwifery, Rasht

Where to obtain:
Library of Shahid Beheshti Faculty of Midwifery and Nursing of Rasht as well as a written request from the project implementer

How to obtain:
Permission from the librarian of Shahid Beheshti Faculty of Midwifery and Nursing in Rasht in writing and Contact the project implementer and conduct a moral agreement

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Bostani Khalesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Faculty of Nursing and Midwifery, Student Park, Yakhsazi Square, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>z_bostani@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Bostani Khalesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Faculty of Nursing and Midwifery, Student Park, Yakhsazi Square, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>z_bostani@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nulliparity
Gestational age 28-32 weeks
Single pregnancy
Reading and writing literacy
Iranian citizenship
Satisfaction and interest in participating in the study
Having a mobile phone with Android system and the ability to install software
Ability to use and work with mobile software
Decided to have a leading delivery at Alzahra education, research &amp; remedial center</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having an underlying and chronic disease
Having indications for cesarean section
History of participating in prenatal care training programs and childbirth preparation classes
Having education in medical fields
Reluctance to continue participating in the study</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: Before the implementation of the training program, version A of the Wijma Delivery Expectancy/Experience Questionnaire in both intervention and control groups will be completed by the research units and then the training software will be installed on the test group mobile phones and these people receive this training in addition to receiving routine prenatal care. It should be noted that the control group does not receive any intervention from the researcher and will only be under routine care during pregnancy. In order not to disrupt the research process, the control group will not be informed of the installation of software on the phone of the experimental group, and this is possible by selecting the members of the experimental and control groups on separate days and not colliding with each other. The use of software during the study period will be reminded once a week by sending a text message to the mothers of the experimental group by the researcher. In order to answer the mothers in case of problems or ambiguity and questions, the researcher's phone number will be provided to the mothers. At the end of the 8-week training period, at the first visit of the research units to the hospital for care (referral time will be planned by the researcher and coordinated with individuals), again, version A of the Wijma Delivery Expectancy/Experience Questionnaire will be provided to the research units of both test and control groups and will be completed by them in the presence of the researcher. The mothers of the test and control groups will be instructed to inform the researcher of the time of their delivery (whether normal delivery or cesarean section). Version B of  Wijma Delivery Expectancy/Experience Questionnaire will be provided to the study units after delivery by the researcher in person at the hospital where the delivery was completed. In this research, educational content including designing and compiling educational software by an experienced programming expert based on the explanation of the delivery process, methods of reducing labor pain, training different positions during labor and childbirth, stretching exercises, respiratory pattern, relaxation and massage. The educational content provided in the software will be taken from the book "Pregnancy and childbirth training" published by the Ministry of Health and Medical Education. This book includes 5 sections: pregnancy, childbirth, postpartum, baby care and stretching exercises, breathing pattern, relaxation and massage. The content will be extracted from the second part (childbirth) and the fifth part (stretching exercises, breathing pattern, relaxation and massage).</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention from the researcher and will only be under routine care during pregnancy. In order not to disrupt the research process, the control group will not be informed of the installation of software on the phone of the experimental group, and this is possible by selecting the members of the experimental and control groups on separate days and not colliding with each other.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth in pregnant women. Timepoint: Before intervention, after intervention (after 8 weeks of educational intervention), immediately after delivery. Method of measurement: Will be measured by standard tool Wijma Delivery Expectancy/Experience Questionnaire. There are 2 versions of this questionnaire. Version A measures the fear of childbirth during pregnancy and version B measures the experience of mothers after childbirth. In this study, the researcher uses both versions A and B of this questionnaire. In this study, the researcher uses both versions A and B of this questionnaire. Both versions of this tool contain 33 items that are scored in a 6-point range. Scores in each question range from zero to five. The minimum score is zero and the maximum score is 165. A higher score indicates more fear. This questionnaire was first designed in Sweden by Wijma et al. (1990) and localized in Iran by Mortazavi (2017).</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-16</approval_date>
        <contact_name>Ethical Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>In front of 17 Shahrivar Hospital, Shahid Siadati Ave. , Namjoo St. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
