Determining the effectiveness of the gamification method to teach pubertal health in adolescent girls of Babol city
Determining the average score of pubertal health awareness and performance in adolescent girls of Babol city
Comparison of the change in the average puberty health awareness score in two gamification and control groups, immediately and one month after the intervention in teenage girls of Babol city.
Comparison of the change in the average puberty health performance score in two gamification and control groups immediately and one month after the intervention in adolescent girls of Babol city.
Design
Clinical trial with control group, with random selection, phase 3 on 90 students. A lottery will be used for randomization.
Settings and conduct
The location of the study is girls' schools in the city of Babol. An in-person meeting will be held to complete the questionnaire, and then the intervention will take place once a week for 4 weeks.
Participants/Inclusion and exclusion criteria
Students' willingness to participate in the study
Parents' consent for their children's participation
Acceptance of participation by the school
female students aged 12-13 years
7th grade students
Having at least three menstrual experiences
The ability to work with mobile phones and laptops to implement gamification in the intervention group Obtaining an average and unfavorable score from the knowledge and performance questionnaire (scoring 32 to 85 points)
Intervention groups
Puberty health educational platform based on gamification components and according to the educational content of puberty health based on the educational package. These materials are presented to students once a week during four weeks. No intervention is performed in the control group.
Main outcome variables
The average score of adolescent girls' knowledge in the field of pubertal health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038783N4
Registration date:2023-07-30, 1402/05/08
Registration timing:prospective
Last update:2023-07-30, 1402/05/08
Update count:1
Registration date
2023-07-30, 1402/05/08
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
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of gamification method for puberty health education in adolescent girls in Babol
Public title
The effectiveness of gamification method for puberty health education in adolescent girls
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students' willingness to participate in the study
Parents' consent for their children's participation
Acceptance of participation by the school
female students aged 12-13 years
7th grade students
The ability to work with mobile phones and laptops to implement gamification in the intervention group
Obtaining an average and unfavorable score from the knowledge and performance questionnaire (scoring 32 to 85 points)
Having at least three menstrual experiences
Exclusion criteria:
Parents' lack of consent for their children's participation
Lack of access to mobile phones and laptops to implement gamification in the intervention group
Obtaining a score less than 32 and more than 85 from the knowledge and performance questionnaire
Absence of menstruation
Age
From 12 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we need at least four schools, and an equal number of schools will be randomly assigned to the control and intervention groups using lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the design of an educational platform was used to implement gamification rules and teach puberty health to students.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.MUBABOL.REC.1402.026
Health conditions studied
1
Description of health condition studied
Awareness and performance in the field of puberty health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The average score of adolescent girls' knowledge in the field of pubertal health
Timepoint
before the start of the intervention, immediately and four weeks after the intervention in the intervention and control regimes
Method of measurement
Maturity Awareness and Knowledge Questionnaire
Secondary outcomes
1
Description
The average performance score of adolescent girls in the field of pubertal health
Timepoint
before, immediately and four weeks after the intervention in two intervention and control groups
Method of measurement
Maturity Awareness and Performance Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: receiving education related to puberty health using a platform designed by Danoosh Shira company, and its sessions and challenges are prepared by the researcher using gamification method, and students will complete it once a week for four weeks using laptops or mobile phones.
Category
Behavior
2
Description
Control group: There is no intervention. One hour of routine training is offered by midwives to both groups.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
First secondary schools of Babol city
Full name of responsible person
Dr. Fareshte Bahmanesh
Street address
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
f.behmanesh@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
ramazan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
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
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
474745-47176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
f.behmanesh@mubabol.ac.ir
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 Babol University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
f.behmanesh@mubabol.ac.ir
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
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
f.behmanesh@mubabol.ac.ir
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