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Improving menstrual hygiene in girls aged 12 to 16 years through the training of health educators

Protocol summary

Study aim
Improving menstrual hygiene in girls aged 12 to 16 years through the training of school teachers
Design
The study group: female students, ages 14 to 16 years old, in the second level of high school in Islamshahr. Sample size: 100 students randomly from 37 Islamic schools in the city, a total of 3,700 people who will enter the study then 740 of them receive training in the initial survey, and evaluated after the exam. Trial phase: not applicant Not blinded According to the statistics and methodology expert, only up to 15% absenteeism and non-response and defects in the questionnaire are not a problem. If it is more than that, the alternative sample will be selected.
Settings and conduct
Place: IslamShahr The current research is a semi-experimental interventional study. Before-after evaluation, single group, the research units two months after completing the training; They are randomly tested based on the questionnaire prepared and the level of awareness of menstrual hygiene is checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having perfect health, having the experience of starting menstruation, and willingness to participate in research Exclusion criteria: presence of any special problems and diseases, unwillingness
Intervention groups
Girls in the age group of 12 to 16 years old in Islamshahr schools In this intervention, after the initial evaluations, menstrual health training is given to the trainers and they give it to the students, and the level of the girls is evaluated and compared with the original sample.
Main outcome variables
Awareness of menstrual hygiene, menstrual hygiene behaviors, symptoms and examination of PMS, PCOS symptoms, presence of endometriosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231023059817N2
Registration date: 2023-12-29, 1402/10/08
Registration timing: registered_while_recruiting

Last update: 2023-12-29, 1402/10/08
Update count: 0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Mohammad Haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2253 9892
Email address
mohammadhaddadi1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improving menstrual hygiene in girls aged 12 to 16 years through the training of health educators
Public title
Improving menstrual hygiene in girls aged 12 to 16 years through the training of health educators
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having perfect health (no history or known disease) Having the experience of starting menstruation (at least two cycles have passed since the start of menstruation) Willingness to participate in the research (through the informed consent of the parents to participate in the research, every parent who is satisfied registers their consent in the school office for their child to participate in the study)
Exclusion criteria:
The existence of any special problem and disease Reluctance to participate in classes
Age
From 12 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 740
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of Imam Khomeini Hospital Complex
Street address
Imam khomeni hospital complex, Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.274

Health conditions studied

1

Description of health condition studied
Menstrual hygiene in girls
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Menstrual health behaviors
Timepoint
Before and after training
Method of measurement
questionnaire

2

Description
Awareness of menstrual hygiene
Timepoint
Before and after training
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Menstrual hygiene (bathing during menstruation; the role of washing in causing uterine infection; the normality of pain under the heart in the first days of menstruation; the correct action in case of no menstruation and physical changes during menstruation; mental and mood changes during menstruation; how Nutrition during menstruation) - Training on premenstrual syndrome and its symptoms - Training on symptoms of endometriosis - Training on symptoms of polycystic ovary syndrome
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
High schools for girls in Islam Shahr
Full name of responsible person
Sedigheh Hantoushzadeh
Street address
Vali-E-Asr Reproductive Health Research Center, Family Health Research Institute, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 127 1209
Email
Hantoushzadeh@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ZARRIN ROYA
Full name of responsible person
Kamyar Tabarokpour
Street address
No. 30, Seventh Avenue, Khaled Islambuli St. (Vozara), Argentina Square
City
Tehran
Province
Tehran
Postal code
15113714511
Phone
+98 21 8810 7040
Email
kamyar.tabarokpour@zarringc.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ZARRIN ROYA
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Hantoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
hantoushzadeh@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedigheh Hantoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
hantoushzadeh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9320
Email
mohammadhaddadi1997@gmail.com

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file will not be publicly available in any way, but only its report will be published in the form of an article. The data will be made available separately to the Ministry of Health and Medicine on their request, or to the researchers if it is known which data will be used in which case. The informed consent form will also be provided during the publication of the article upon the request of the editor of the journal, and the methods of statistical analysis will be partially represented in the article, and the rest of the information will be available to the researchers upon request.
When the data will become available and for how long
Start of access based on the protocol up to one year after publishing the results
To whom data/document is available
Ministry of Health The researchers behind the plan The editor of the magazine to be published Researchers based on the protocol Responsible sponsor of the plan
Under which criteria data/document could be used
In the case of health planning by the Ministry of Health and in case of use in other approved research projects
From where data/document is obtainable
An official email should be sent to the main person responsible for the project
What processes are involved for a request to access data/document
First, the request in the official form and letterhead is sent to the project manager. This request will be reviewed at the M. Red Nahar Research Center and the requested data will be provided after being blinded and anonymized if approved.
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