<?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>IRCT20180707040364N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-27</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey the effect of educational intervention using mobile application on health literacy in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Survey the effect of educational intervention using mobile application on health literacy in pregnant women attending Alzahra education, research &amp; remedial Center in Rasht city 2019_2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38390</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: All items are in the summary section, Randomization description: Research units are selected based on gradual referral if they have criteria for entering the study. Assigned units will be assigned numbers 1 to 140, respectively. A table with 35 rows is called a block, and each part of the block will be named with the letters A and B. In the next step, numbers are placed in each house, respectively. Then all the numbers are embedded in the blocks. 35 blocks are randomly drawn. Random blocks are placed in a lacquered envelope and will be kept in the center of research and social factors affecting health. The Hawzah Bloc is selected after the beginning of the study by an individual who is not aware of the type of blocks. People at Home A will be placed in the test group in the test group and those at Home B will be placed in the control group, Blinding description: Participants are unaware of the allocation of study groups. The outcome evaluator will not be aware of the random assignment of the test and control group and will examine the data related to the outcome variables, regardless of the groups of individuals. After collecting data, groups are named in alphabetical order so that the analyst from the test and control group is not informed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>health literacy in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Control group: the control group is not subject to any intervention by the researcher. To avoid contacting the mothers of the test and control group with each other, mothers are called to the prenatal care unit individually, and the researcher will read the questions individually for mothers and the mother will answer them. Pregnant women in the test group will not have any contact with the control group's mothers after the software is installed. Mothers of the control group are trying to avoid knowing the software installation on the test group smartphones. Intervention 2: Intervention group: Before the implementation of the maternity health literacy questionnaire, the mother-tongue questionnaire was completed by a researcher by interviewing the mothers in two groups of test and control, then the software will be installed on the smartphone of the test group, one week after the installation of the program They will be contacted on the cell phone of the mothers of the test group and will be asked questions and problems related to the use of the software. It should be noted that the control group is not subject to any intervention by the researcher. To avoid contacting the mothers of the test and control group with each other, mothers are called to the prenatal care unit individually, and the researcher will read the questions individually for mothers and the mother will answer them. Pregnant women in the test group will not have any contact with the control group's mothers after the software is installed. Mothers of the control group are trying to avoid knowing the software installation on the test group smartphones. Then, 8 weeks later, the date for the referral of the mothers of the test and control group to the prenatal care clinic of Alzahra's educational and research center will be determined by the researcher. If the mothers do not go to a pregnancy care clinic of al-Zahra hospital on a definite date When the researcher comes to the door, the same questionnaire will be given back to the mothers. The mothers of the test group will be given the opportunity to study the contents of the software in the course of 8 weeks, once a week. At intervals of 8 weeks, weekly counseling is provided once a week for 10 minutes with the mothers of the test group to remind and ask mothers about the study of the software. The time of making phone calls is determined by the consideration of pregnant mothers. In order to comply with the ethical standards of mobile software, after the end of the study, the pregnant women will also be placed in the control group. In this study, educational content includes design and software development by a skilled programmer based on explaining body changes and adaptations during pregnancy, fetal development, prenatal care, testing, vaccination, nutrition, dietary supplements Personal hygiene, employment, travel, rest, exercise, sex, addiction, drug use, risk of pregnancy, neonatal care, bathing and breastfeeding, neonatal risk, use of vitamins, infant status and coverage is. The educational content provided in the software is derived from the book of pregnancy and childbirth education provided by the Ministry of Health and Medical Education, the Health and Welfare Department of the Population Health, Family, Schools and Mental Health Administration. The book includes 5 parts of pregnancy, childbirth, postpartum, baby care and stretching exercises, respiratory pattern, relaxation and massage, which in the first part about reproductive system, changes in body adaptation in pregnancy, growth and Embryo development, Prenatal care, Nutrition during pregnancy, Supplements during pregnancy, Individual health, Pregnancy risk symptoms, Pregnancy and maternity, Part II on delivery and methods for reducing labor pain , In the third section on postpartum organ changes, postpartum and postnatal risk symptoms, and in the fourth section about me Neonatal birth, Neonatal screening, Vaccination, Bathing and Breastfeeding, and in the fifth part, about tensile and respiratory exercises during pregnancy, modifying the condition during pregnancy and the pattern of respiration and sedation during pregnancy and postpartum, expressing and The description of the material has been discussed.</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:
The start of the access period is 8 months after the results are printed

To whom:
Academic and academic institutions

Conditions:
If you cite the article

Where to obtain:
executor of plan

How to obtain:
Contact the plan 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>Rasht-Flick Ice-Park-Student-Faculty of Nursing-Midwifery Martyr Dr. Beheshti</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939114</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>Rasht-Flick Ice-Park-Student-Faculty of Nursing-Midwifery Martyr Dr. Beheshti</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939114</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>Nullie Parithe
Gestational age 6 to 12weeks
Reading and writing literacy
Iranian citizenship
Minors aged 18 and up to 45
Having a mobile phone with the Android system and the ability to install the software
Not having chronic and underlying disease
Lack of medical education,
Inability to use and operate with mobile software
No history of participation in a pregnancy care education program
Satisfaction and interest in participating in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue participating in a work 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>Control group: the control group is not subject to any intervention by the researcher. To avoid contacting the mothers of the test and control group with each other, mothers are called to the prenatal care unit individually, and the researcher will read the questions individually for mothers and the mother will answer them. Pregnant women in the test group will not have any contact with the control group's mothers after the software is installed. Mothers of the control group are trying to avoid knowing the software installation on the test group smartphones</i_keyword>
      <i_keyword>Intervention group: Before the implementation of the maternity health literacy questionnaire, the mother-tongue questionnaire was completed by a researcher by interviewing the mothers in two groups of test and control, then the software will be installed on the smartphone of the test group, one week after the installation of the program They will be contacted on the cell phone of the mothers of the test group and will be asked questions and problems related to the use of the software. It should be noted that the control group is not subject to any intervention by the researcher. To avoid contacting the mothers of the test and control group with each other, mothers are called to the prenatal care unit individually, and the researcher will read the questions individually for mothers and the mother will answer them. Pregnant women in the test group will not have any contact with the control group's mothers after the software is installed. Mothers of the control group are trying to avoid knowing the software installation on the test group smartphones. Then, 8 weeks later, the date for the referral of the mothers of the test and control group to the prenatal care clinic of Alzahra's educational and research center will be determined by the researcher. If the mothers do not go to a pregnancy care clinic of al-Zahra hospital on a definite date When the researcher comes to the door, the same questionnaire will be given back to the mothers. The mothers of the test group will be given the opportunity to study the contents of the software in the course of 8 weeks, once a week. At intervals of 8 weeks, weekly counseling is provided once a week for 10 minutes with the mothers of the test group to remind and ask mothers about the study of the software. The time of making phone calls is determined by the consideration of pregnant mothers. In order to comply with the ethical standards of mobile software, after the end of the study, the pregnant women will also be placed in the control group. In this study, educational content includes design and software development by a skilled programmer based on explaining body changes and adaptations during pregnancy, fetal development, prenatal care, testing, vaccination, nutrition, dietary supplements Personal hygiene, employment, travel, rest, exercise, sex, addiction, drug use, risk of pregnancy, neonatal care, bathing and breastfeeding, neonatal risk, use of vitamins, infant status and coverage is. The educational content provided in the software is derived from the book of pregnancy and childbirth education provided by the Ministry of Health and Medical Education, the Health and Welfare Department of the Population Health, Family, Schools and Mental Health Administration. The book includes 5 parts of pregnancy, childbirth, postpartum, baby care and stretching exercises, respiratory pattern, relaxation and massage, which in the first part about reproductive system, changes in body adaptation in pregnancy, growth and Embryo development, Prenatal care, Nutrition during pregnancy, Supplements during pregnancy, Individual health, Pregnancy risk symptoms, Pregnancy and maternity, Part II on delivery and methods for reducing labor pain , In the third section on postpartum organ changes, postpartum and postnatal risk symptoms, and in the fourth section about me Neonatal birth, Neonatal screening, Vaccination, Bathing and Breastfeeding, and in the fifth part, about tensile and respiratory exercises during pregnancy, modifying the condition during pregnancy and the pattern of respiration and sedation during pregnancy and postpartum, expressing and The description of the material has been discussed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health literacy in pregnant women. Timepoint: Before and after intervention. Method of measurement: Will be measured by maternal health literacy tool. The maternity health literacy questionnaire has 14 rows. The maternal health literacy scores range from 14 to 70. The items in this questionnaire are based on Likert Five Degrees of Totally Agree (Score 5), Agree (Score 4), I have no idea (Score 3), Disagree (Score 2), and Absolutely Disagree (Score 1), More Score The donor is better educated. The maternal health literacy questionnaire was created by Maguonilla (2011) in Nigeria and is localized by Peyman et al. (2016).</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>2019-03-09</approval_date>
        <contact_name>Ethical Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Rasht, Namji Street, Shahid Siadati Street, opposite the 17th Shahrivar Hospital Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
