Protocol summary
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Study aim
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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.
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Design
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Clinical trial with control group, with random selection, phase 3 on 90 students. A lottery will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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.
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Main outcome variables
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The average score of adolescent girls' knowledge in the field of pubertal health
General information
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Reason for update
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Need more time for sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180218038783N4
Registration date:
2023-07-30, 1402/05/08
Registration timing:
prospective
Last update:
2024-01-08, 1402/10/18
Update count:
1
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Registration date
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2023-07-30, 1402/05/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-01, 1402/08/10
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Expected recruitment end date
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2025-01-09, 1403/10/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of gamification method for puberty health education in adolescent girls in Babol
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Public title
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The effectiveness of gamification method for puberty health education in adolescent girls
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 12 years old to 13 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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In this study, the design of an educational platform was used to implement gamification rules and teach puberty health to students.
Ethics committees
1
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Ethics committee
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Approval date
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2023-06-17, 1402/03/27
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Ethics committee reference number
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IR.MUBABOL.REC.1402.026
Health conditions studied
1
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Description of health condition studied
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Awareness and performance in the field of puberty health
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The average score of adolescent girls' knowledge in the field of pubertal health
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Timepoint
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before the start of the intervention, immediately and four weeks after the intervention in the intervention and control regimes
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Method of measurement
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Maturity Awareness and Knowledge Questionnaire
Secondary outcomes
1
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Description
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The average performance score of adolescent girls in the field of pubertal health
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Timepoint
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before, immediately and four weeks after the intervention in two intervention and control groups
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Method of measurement
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Maturity Awareness and Performance Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: There is no intervention. One hour of routine training is offered by midwives to both groups.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available