History
# Registration date Revision Id
2 2024-02-08, 1402/11/19 294346
1 2024-01-19, 1402/10/29 291883
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  • Protocol summary

    طراحی، اجرا و ارزشیابی آموزش پروتکل زایمانی با روش گیمیفیکیشن (بازی واره ) توسط اپلیکیشن بر یادگیری دانشجویان مامایی
    طراحی، اجرا و ارزشیابی آموزش پروتکل زایمانی با روش گیمیفیکیشن (بازی واره) توسط اپلیکیشن بر یادگیری دانشجویان مامایی
  • General information

    طراحی و اجرای آموزش پروتکل زایمانی توسط اپلیکیشن با روش گیمیفیکیشن (بازی واره ) و ارزشیابی تاثیر بکارگیری آن توسط دانشجویان مامایی
    طراحی و اجرای آموزش پروتکل زایمانی توسط اپلیکیشن با روش گیمیفیکیشن (بازی واره) و ارزشیابی تاثیر بکارگیری آن توسط دانشجویان مامایی
  • Intervention groups

    #1
    Intervention: All students who consent to participate in the study will be randomly divided into two groups. Half of the topics for one group (intervention) will be taught with gamification method and for the second group (control) with conventional method, and in the continuation of the study, the other half of the topics for the primary control group will be taught with gamification method and for the primary intervention group with the conventional method will be taught. Six topics of natural and unnatural childbirth practice (vaginal examination, control of mother's vital signs, control of fetal heart rate, control of uterine contractions, drawing of partographs and investigation of episiotomy) in both gamification and traditional forms with contents It will be prepared exactly the same. Before starting the study, the students will complete the 20-question knowledge assessment test as well as the demographic and emotional intelligence questionnaire of Siberia Sharing, and their performance at the mother's bedside will be evaluated using a checklist. Immediately and four weeks after the completion of the interventions, the students will respond to the delivery protocol test and their performance at the mother's bedside will be evaluated using a designed checklist.
    Intervention: All students who consent to participate in the study will be randomly divided into two groups. Half of the topics for one group (intervention) will be taught with gamification method and for the second group (control) with conventional method, and in the continuation of the study, the other half of the topics for the primary control group will be taught with gamification method and for the primary intervention group with the conventional method will be taught. Some topics of natural and unnatural childbirth practice (vaginal examination, control of mother's vital signs, control of fetal heart rate, control of uterine contractions,placental examination, drawing of partographs and investigation of episiotomy) in both gamification and traditional forms with contents It will be prepared exactly the same. Before starting the study, the students will complete the 20-question knowledge assessment test as well as the demographic and emotional intelligence questionnaire of Siberia Sharing, and their performance at the mother's bedside will be evaluated using a checklist. Four weeks after the completion of the interventions, the students will respond to the delivery protocol test and their performance at the mother's bedside will be evaluated using a designed checklist.
    مداخله:کل دانشجویانی که رضایت به شرکت در مطالعه دارند، به طور تصادفی، به دو گروه تقسیم می شوند. نیمی از مباحث برای یک گروه (مداخله) با روش گیمیفیکیشن و برای گروه دوم (کنترل) با روش مرسوم آموزش داده می شود و در ادامه ی مطالعه، نیمی دیگر از مباحث برای گروه کنترل اولیه با روش گیمیفیکیشن و برای گروه مداخله ی اولیه با روش مرسوم آموزش داده می شود. شش مبحث از مباحث کارورزی زایمان طبیعی و غیرطبیعی (معاینه واژینال، کنترل علائم حیاتی مادر، کنترل صدای قلب جنین، کنترل وضعیت انقباضات رحم، رسم پارتوگراف و بررسی محل ترمیم برش یا پارگی) را به دو صورت گیمیفیکیشن و سنتی با محتواهای کاملا یکسان، آماده خواهد شد. قبل از شروع مطالعه، دانشجویان آزمون ۲۰ سواله سنجش دانش و همچنین پرسشنامه دموگرافیک و هوش هیجانی سیبریا شرینگ را تکمیل می کنند و عملکرد آن‌ها در بالین مادر با استفاده از چک لیست ارزیابی خواهد شد. بلافاصله و چهار هفته بعد از اتمام مداخلات نیز دانشجویان به آزمون پروتکل زایمانی پاسخ خواهند داد و عملکرد آن‌ها در بالین مادر با استفاده از چک لیست طراحی شده ارزشیابی خواهد شد.
    مداخله:کل دانشجویانی که رضایت به شرکت در مطالعه دارند، به طور تصادفی، به دو گروه تقسیم می شوند. نیمی از مباحث برای یک گروه (مداخله) با روش گیمیفیکیشن و برای گروه دوم (کنترل) با روش مرسوم آموزش داده می شود و در ادامه ی مطالعه، نیمی دیگر از مباحث برای گروه کنترل اولیه با روش گیمیفیکیشن و برای گروه مداخله ی اولیه با روش مرسوم آموزش داده می شود.چند مبحث از مباحث کارورزی زایمان طبیعی و غیرطبیعی (معاینه واژینال، کنترل علائم حیاتی مادر، کنترل صدای قلب جنین، کنترل وضعیت انقباضات رحم، معاینه جفت، رسم پارتوگراف و بررسی محل ترمیم برش یا پارگی) را به دو صورت گیمیفیکیشن و سنتی با محتواهای کاملا یکسان، آماده خواهد شد. قبل از شروع مطالعه، دانشجویان آزمون ۲۰ سواله سنجش دانش و همچنین پرسشنامه دموگرافیک و هوش هیجانی سیبریا شرینگ را تکمیل می کنند و عملکرد آن‌ها در بالین مادر با استفاده از چک لیست ارزیابی خواهد شد. چهار هفته بعد از اتمام مداخلات نیز دانشجویان به آزمون پروتکل زایمانی پاسخ خواهند داد و عملکرد آن‌ها در بالین مادر با استفاده از چک لیست طراحی شده ارزشیابی خواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Babol University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی بابل
    Full name of responsible person - English: Dr.Mahdi Rajabnia
    Full name of responsible person - Persian: دکتر مهدی رجب نیا
    Street address - English: Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
    Street address - Persian: بابل، خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 47745-471676
    Phone: +98 11 3219 9592
    Fax: +98 11 3219 0181
    Email: ramazan@yahoo.com
    Web page address:
    Name of recruitment center - English: Babol University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی بابل
    Full name of responsible person - English: Mehdi Rajabnia
    Full name of responsible person - Persian: دکتر مهدی رجب نیا
    Street address - English: Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
    Street address - Persian: بابل، خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 47745-471676
    Phone: +98 11 3219 9592
    Fax: +98 11 3219 0181
    Email: ramazan@yahoo.com
    Web page address:
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fereshteh Behmanesh
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Midwifery and Counseling
    Position - Persian: استادیار گروه مامایی و مشاوره
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, University Square, Ganj Afrooz Street, Babol.
    Street address - Persian: بابل، خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 47745-471676
    Phone: +98 11 3219 9592
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fereshteh Behmanesh
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Midwifery and Counseling
    Position - Persian: استادیار گروه مامایی و مشاوره
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, University Square, Ganj Afrooz Street, Babol.
    Street address - Persian: خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 47745-471676
    Phone: +98 11 3219 9592
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: فرشته بهمنش
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Midwifery and Counseling
    Position - Persian: استادیار گروه مامایی و مشاوره
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Keshavarz
    Street address - Persian: بابل، خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: Babol
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4718758563
    Phone: +9832199594
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fereshteh Behmanesh
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Midwifery and Counseling
    Position - Persian: استادیار گروه مامایی و مشاوره
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
    Street address - Persian: خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: Babol
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4718758563
    Phone: +9832199594
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: فرشته بهمنش
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Babol University of Medical Sciences
    Position - Persian: استادیار دانشگاه علوم پزشکی بابل
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Keshavarz
    Street address - Persian: بابل، خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: Babol
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4718758563
    Phone: +9832199594
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fereshteh Behmanesh
    Full name of responsible person - Persian: فرشته بهمنش
    Position - English: Assistant Professor of Babol University of Medical Sciences
    Position - Persian: استادیار دانشگاه علوم پزشکی بابل
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
    Street address - Persian: خیابان گنج افروز، میدان دانشگاه، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4718758563
    Phone: +9832199594
    Mobile: +98 911 213 5312
    Fax: +98 11 3219 0181
    Email: f.behmanesh2015@gmail.com
    Web page address:

Protocol summary

Study aim
Design and implementation of delivery protocol training for midwifery students with an application based on gamification method and evaluation of its usage by midwifery students
Design
Clinical trial with control group, crossover design, random selection of groups on 35 midwifery students
Settings and conduct
The location of the project is the maternity ward of Babol University of Medical Sciences hospitals. All students will be selected and randomly divided into two groups A and B. Half of the topics for group A will be taught with gamification method and the rest of the topics will be taught with traditional method.In group B, on the contrary.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obtaining written consent from students to participate in the study; obtaining a natural and unnatural childbirth internship. Exclusion criteria: obtain a natural and unnatural childbirth internship unit and the use of natural and unnatural childbirth in the past semesters.
Intervention groups
A link to enter the game will be sent to each student once a week. The contents of the delivery protocol will be presented to the students in the form of theory and challenges. Students will earn points by answering the challenges.
Main outcome variables
Students' satisfaction, average knowledge score and average delivery protocol performance score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180218038783N7
Registration date: 2024-01-19, 1402/10/29
Registration timing: prospective

Last update: 2024-02-13, 1402/11/24
Update count: 1
Registration date
2024-01-19, 1402/10/29
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0504
Email address
f.behmanesh@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2026-02-04, 1404/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and implementation of delivery protocol training for midwifery students with an application based on gamification method and evaluation of its usage by midwifery students
Public title
Effectiveness of gamification method for delivery protocol training on midwifery students
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining written consent from students to participate in the study Obtaining the course unit of natural and abnormal childbirth internship Midwifery student
Exclusion criteria:
Failure to take the training course of natural and unnatural childbirth in the previous semesters
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of the University of Intelligent Medical Sciences
Street address
Number 3, First Avenue, Koh Noor Street, Motahari Street, Tehran
City
Tehran
Province
Tehran
Postal code
3614773955
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.SMUMS.REC.1402.029

Health conditions studied

1

Description of health condition studied
Natural delivery
ICD-10 code
Z55
ICD-10 code description
Problems related to education and literacy

Primary outcomes

1

Description
Knowledge and performance of the delivery protocol
Timepoint
Before, immediately and one month after the study, it is evaluated through a questionnaire and a checklist of performance at the mother's bedside.
Method of measurement
The delivery protocol knowledge questionnaire: This questionnaire contains 20 questions from the national guide to the provision of midwifery and maternity services and from six topics presented, designed by the researcher. Checklist for the performance of the delivery protocol: This checklist is made up of six topics designed by the research team and each student will be evaluated separately by the researcher on the mother's clinic.

Secondary outcomes

1

Description
Student satisfaction
Timepoint
Upon completion of the intervention will be completed by the students.
Method of measurement
The questionnaire includes questions to measure student satisfaction with the interventions.(Designed by the researcher.)

Intervention groups

1

Description
Intervention: All students who consent to participate in the study will be randomly divided into two groups. Half of the topics for one group (intervention) will be taught with gamification method and for the second group (control) with conventional method, and in the continuation of the study, the other half of the topics for the primary control group will be taught with gamification method and for the primary intervention group with the conventional method will be taught. Some topics of natural and unnatural childbirth practice (vaginal examination, control of mother's vital signs, control of fetal heart rate, control of uterine contractions,placental examination, drawing of partographs and investigation of episiotomy) in both gamification and traditional forms with contents It will be prepared exactly the same. Before starting the study, the students will complete the 20-question knowledge assessment test as well as the demographic and emotional intelligence questionnaire of Siberia Sharing, and their performance at the mother's bedside will be evaluated using a checklist. Four weeks after the completion of the interventions, the students will respond to the delivery protocol test and their performance at the mother's bedside will be evaluated using a designed checklist.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
City
Babol
Province
Mazandaran
Postal code
47745-471676
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
ramazan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
ramazan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Smart University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor of Midwifery and Counseling
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, University Square, Ganj Afrooz Street, Babol.
City
Babol
Province
Mazandaran
Postal code
47745-471676
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
f.behmanesh2015@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor of Midwifery and Counseling
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+9832199594
Fax
+98 11 3219 0181
Email
f.behmanesh2015@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor of Babol University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+9832199594
Fax
+98 11 3219 0181
Email
f.behmanesh2015@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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