<?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>IRCT20230510058147N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-12</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact and evaluation of the educational intervention based on gamification in childbirth preparation classes on the dimensions of maternal adaptation in pregnant women.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact and evaluation of educational intervention based on gamification in childbirth preparation classes on the dimensions of maternal adaptation in pregnant women covered by comprehensive health service centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, a type of game called Mamano is used for education; which was made by the researcher, Randomization description: Sampling will be done by simple random; In this way, a list of all pregnant women participating in childbirth preparation classes has been prepared, then people will be randomly selected from the desired list and will be included in the study if they meet the entry criteria; Otherwise, another person will be replaced. Allocation of people to test and control groups will be done using the method of two and four permutation blocks. This list is prepared by the statistical consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Education of pregnant mothers.</hc_freetext>
      <i_freetext>Intervention 1: In 8 sessions, pregnant mothers are trained by gamification and routine for 90 minutes (once a week). The question and answer part of the class is done using a game, and mothers will answer the questions in two groups of 5 people, and for each correct answer, they will receive a bonus card. Questionnaires will be completed by mothers at the beginning of the study, immediately after completion and one month after completion. The teaching content of the book is pregnancy training and preparation for childbirth. The game used was made by the researcher and is made from a number of cards that are placed on a device and the device has a pen, voice and score counter. Intervention 2: Control group: pregnant mothers who only receive routine training. The content of the training and the number of sessions and its duration are not different from 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data are pregnant mothers and can be shared after de-identifying the names of all individuals.

When:
The access period starts after the results are printed

To whom:
Researchers in the field of midwifery training and other medical science groups

Conditions:
Researchers can use the work method, the type of participants by mentioning the name of the main researcher and the relevant university.0

Where to obtain:
Tahere Tavasoli, tahere.tavasoli.55@gmail.com, mobile number 09157271241
Dr. Fariba Askari faribaaskari10@yahoo.com, mobile number 09151778676

How to obtain:
In case of a request, the request will be answered within a week after the review.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere Tavasoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, 29 Shahid Shourideh St</address>
        <city>Gonanbad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691963745</zip>
        <telephone>+98 51 5725 9344</telephone>
        <email>tavasoli.t@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahere Tavasoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, 29 Shahid Shourideh St</address>
        <city>Gonanbad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691963745</zip>
        <telephone>+98 51 5725 9344</telephone>
        <email>tavasoli.t@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Willingness to participate in the study
Age range of 18-45 years
Literacy for reading and writing
Gestational age 20 to 28 weeks
No medical problems (such as diabetes and blood pressure, mental illnesses, multiple births and heart and respiratory diseases)
Absence of pregnancy with special care (history of bleeding in the same pregnancy, placenta previa, cerclage, pregnancy with assisted reproduction methods)
No addiction
No intense family conflict
The mother (pregnant woman's mother) must be alive.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The event of a stressful event (divorce, death of close relatives,...)
Absence of more than one meeting
Withdrawal from the study
Using virtual training</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In 8 sessions, pregnant mothers are trained by gamification and routine for 90 minutes (once a week). The question and answer part of the class is done using a game, and mothers will answer the questions in two groups of 5 people, and for each correct answer, they will receive a bonus card. Questionnaires will be completed by mothers at the beginning of the study, immediately after completion and one month after completion. The teaching content of the book is pregnancy training and preparation for childbirth. The game used was made by the researcher and is made from a number of cards that are placed on a device and the device has a pen, voice and score counter.</i_keyword>
      <i_keyword>Control group: pregnant mothers who only receive routine training. The content of the training and the number of sessions and its duration are not different from the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average scores of maternal adaptation. Timepoint: The beginning of the study, immediately after completion and one month after the study. Method of measurement: PSEQ questionnaire.</prim_outcome>
      <prim_outcome>Average reaction. Timepoint: Immediately after completing the study. Method of measurement: Kirkpatrick questionnaire.</prim_outcome>
      <prim_outcome>Average learning scores. Timepoint: The beginning of the study, immediately after completion and one month after the study. Method of measurement: A 10-question test made by the researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal adjustment score. Timepoint: First, immediately and one month after the study. Method of measurement: PSEQ questionnaire.</sec_outcome>
      <sec_outcome>Educational intervention evaluation score. Timepoint: First, immediately and one month after the study. Method of measurement: Kirkpatrick 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-10</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>No. 18, Shahid Shurideh 29 Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
