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
-Determining the effect of educational intervention based on gamification in childbirth preparation classes on the dimensions of maternal adaptation during pregnancy in pregnant women covered by comprehensive health service centers in Shahr Gonabad in 1402
- Determining the effectiveness of gamification-based training in childbirth preparation classes based on the first and second levels of the Kirkpatrick evaluation model in pregnant women covered by comprehensive health service centers in Shahr Gonabad in 1402
Design
Clinical trial with control group, with parallel groups, not blinded, randomized on 80 pregnant mothers.
Settings and conduct
in the city of Gonabad
Random distribution of pregnant mothers
Completing the questionnaire (PSEQ and demographics) and a 10-question test in two groups
Separate training in the form of routine training and gamification training
Re-completion of the questionnaire (PSEQ and Kirkpatrick) and test
Re-completion of questionnaire (PSEQ) and test after one month
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Age range of 18-45 years
• Literacy for reading and writing
• Gestational age 20 to 28 weeks
• No medical problems
• Absence of pregnancy with special care
• No addiction
• No intense family conflict
• The mother (pregnant woman's mother) must be alive.
Exit criteria:
• The event of a stressful event
• Absence of more than one meeting
• Withdrawal from the study
• Using virtual training
Intervention groups
Training pregnant mothers in the intervention group in the form of routine and gamification
Routine training of pregnant mothers in the control group
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
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.
Purpose
Education/Guidance
Inclusion/Exclusion 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.
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a type of game called Mamano is used for education; which was made by the researcher.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
No. 18, Shahid Shurideh 29
City
Gonabad
Province
Razavi Khorasan
Postal code
9691963745
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
IR.GMU.REC.1402.027
Health conditions studied
1
Description of health condition studied
Education of pregnant mothers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
Average reaction
Timepoint
Immediately after completing the study
Method of measurement
Kirkpatrick questionnaire
3
Description
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
Secondary outcomes
1
Description
Maternal adjustment score
Timepoint
First, immediately and one month after the study
Method of measurement
PSEQ questionnaire
2
Description
Educational intervention evaluation score
Timepoint
First, immediately and one month after the study
Method of measurement
Kirkpatrick questionnaire
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Fayaz Bakhsh comprehensive health service center
Full name of responsible person
Mrs. Dr. Munira Danyai
Street address
Ghadir Square, next to the Blood Transfusion Organization
City
Gonabad
Province
Razavi Khorasan
Postal code
969199967
Phone
+98 51 5722 2598
Email
monire.donyaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Momeni Moghadam
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
Aminmomeni90@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Gonabad University of Medical Sciences
Full name of responsible person
Tahere Tavasoli
Position
Midwifery graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, 29 Shahid Shourideh St
City
Gonanbad
Province
Razavi Khorasan
Postal code
9691963745
Phone
+98 51 5725 9344
Fax
Email
tavasoli.t@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Tahere Tavasoli
Position
Midwifery graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, 29 Shahid Shourideh St
City
Gonanbad
Province
Razavi Khorasan
Postal code
9691963745
Phone
+98 51 5725 9344
Fax
Email
tavasoli.t@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Tahere Tavasoli
Position
Midwifery graduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 18, 29 Shahid Shourideh St
City
Gonanbad
Province
Razavi Khorasan
Postal code
9691963745
Phone
+98 51 5725 9344
Fax
Email
tavasoli.t@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data are pregnant mothers and can be shared after de-identifying the names of all individuals.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Researchers in the field of midwifery training and other medical science groups
Under which criteria data/document could be used
Researchers can use the work method, the type of participants by mentioning the name of the main researcher and the relevant university.0
From where data/document is obtainable
Tahere Tavasoli, tahere.tavasoli.55@gmail.com, mobile number 09157271241
Dr. Fariba Askari faribaaskari10@yahoo.com, mobile number 09151778676
What processes are involved for a request to access data/document
In case of a request, the request will be answered within a week after the review.