Puberty ChangesNCT05844839
Awareness of Preparatory Schools Girls About Puberty Changes and Menstrual Hygiene in Abnub District
An observational study of Puberty Changes and Menstrual Hygiene, run by Assiut University.
Trial summary
General objective: Upgrade awareness of adolescent girls during puberty to improve their reproductive health Specific objectives: 1. To assess the awareness about pubertal changes and menstrual hygiene among rural and urban adolescent girls. 2. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Puberty Changes, Menstrual Hygiene
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- Women only
- Child
Study population: Adolescent girls in governmental preparatory schools at Abnub district
Who may be able to join
- Adolescent girls in preparatory schools in Abnub district
Who cannot join
- Married girls
Trial locations and contacts
No sites are listed yet.
About this study
- General objective: Upgrade awareness of adolescent girls during puberty to improve their reproductive health
- Specific objectives:
- To assess the awareness about pubertal changes and menstrual hygiene among rural and urban adolescent girls.
- To identify the determinants of awareness about pubertal changes and menstrual hygiene among adolescent girls.
- To assess the practice of menstrual hygiene among adolescent girls.
Read the detailed description
Adolescence is one of life's most fascinating and complex stages of human life. The World Health Organization (WHO) defines adolescents as young people aged 10-19 years. Attitudes and behaviors formed in the physical and psychological maturation process are crucial to the current and future Reproductive Health (RH) of individuals, and affect the well-being of their families and communities .
Adolescence is a process-a series of varied, rapid and extensive changes as well as period of life about1/5 of the total female population is contributed by adolescent girls. out of which more than 4/5th residing in developing countries adolescence has challenges that can affect not only the future of a girl but also that of her children .
Reproductive Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system, and to its functions and processes. Reproductive health therefore implies that people are able to have a satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when and how often to do so Egypt's young population is rapidly growing. The adolescents (aged 10-19) are around 17 million, representing approximately 19 percent of the total population ,and it is an important stage in the human life span marked by the onset of puberty. It is a stage in which adolescents cross the line between childhood and adulthood Adolescents constitute perhaps the healthiest group in the population, having the lowest mortality and morbidity when compared with other population age groups. Reproductive health covers all aspects of adolescent health. In order to lead healthy, responsible \& fulfilling lives \& protect themselves from reproductive health problems youngsters need to be knowledge- able about themselves\& need adequate information about the physical\& psychological changes that take place during puberty, menstruation, pregnancy \& child birth Puberty can be a challenging time that is often associated with early sexual activity, dropping out of school, substance abuse, unsuccessful marriage, un- wanted pregnancy, sexually transmitted diseases (STDs) and psychosomatic and social problems Adolescent girls form a group exposed to the possibility of being unsafe not only with respect to their social status but also in relation to their health Puberty mean growth from childhood stage to adolescence stage : This Growth is the result of the concerted effect of a complex network of many regulatory factors with varying interactions In females, the normal start of puberty ranges from 8 to 13 years of age, and it is marked by the development of breast buds under the areola; this step is also called thelarche and represents the Tanner Stage B2. In the sequence of events, the thelarche is followed by pubic and axillary hair growth, known as pubarche; in the meantime, growth velocity starts to increase between stage 2 and 3, reaching a peak in stage 4, when the menarche may appear Menstruation although in natural physiological process often associated with misconceptions and the way a girl gets to know about it can lead to a good or bad perception regarding menstruation. Increased knowledge about menstruation from childhood may increase safe practices and may help in eliminating the suffering of millions of women Inadequate menstrual hygienic practices can harmfully affect the health and can lead to reproductive tract infections, chronic pelvic pain, dysmenorrhea and even infertility The onset of puberty, in addition to the rate of maturation, appears to be dependent on heredity and the environment. The age at menarche of identical twin sisters is within 1-2 months of each other, whereas in dizygotic twins there is about a years difference. In general, girls in poor countries have later menarche than in countries with better socioeconomic conditions .
Age at menarche and breast development are clinically easier to assess, data regarding female puberty is significantly more abundant than male data .
- Conditions
- Puberty Changes, Menstrual Hygiene
What is being measured
The primary outcome is the main question the study is designed to answer.
Upgrade awareness of adolescent girls during puberty to improve their reproductive health
questionnair will be prepared to assess this outcome
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puberty ChangesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Tharwat Said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844839
- Sponsor's protocol ID
- Awareness of menstrual hygiene
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Preparatory Schools Girls About Puberty Changes and Menstrual Hygiene in Abnub District
- ClinicalTrials.gov ID
- NCT05844839
- Acronym / sponsor ID
- Awareness of menstrual hygiene
- Conditions
- Puberty Changes, Menstrual Hygiene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- General objective: Upgrade awareness of adolescent girls during puberty to improve their reproductive health
- Specific objectives:
- To assess the awareness about pubertal changes and menstrual hygiene among rural and urban adolescent girls.
- To identify the determinants of awareness about pubertal changes and menstrual hygiene among adolescent girls.
- To assess the practice of menstrual hygiene among adolescent girls.
Detailed description
Adolescence is one of life's most fascinating and complex stages of human life. The World Health Organization (WHO) defines adolescents as young people aged 10-19 years. Attitudes and behaviors formed in the physical and psychological maturation process are crucial to the current and future Reproductive Health (RH) of individuals, and affect the well-being of their families and communities .
Adolescence is a process-a series of varied, rapid and extensive changes as well as period of life about1/5 of the total female population is contributed by adolescent girls. out of which more than 4/5th residing in developing countries adolescence has challenges that can affect not only the future of a girl but also that of her children .
Reproductive Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system, and to its functions and processes. Reproductive health therefore implies that people are able to have a satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when and how often to do so Egypt's young population is rapidly growing. The adolescents (aged 10-19) are around 17 million, representing approximately 19 percent of the total population ,and it is an important stage in the human life span marked by the onset of puberty. It is a stage in which adolescents cross the line between childhood and adulthood Adolescents constitute perhaps the healthiest group in the population, having the lowest mortality and morbidity when compared with other population age groups. Reproductive health covers all aspects of adolescent health. In order to lead healthy, responsible \& fulfilling lives \& protect themselves from reproductive health problems youngsters need to be knowledge- able about themselves\& need adequate information about the physical\& psychological changes that take place during puberty, menstruation, pregnancy \& child birth Puberty can be a challenging time that is often associated with early sexual activity, dropping out of school, substance abuse, unsuccessful marriage, un- wanted pregnancy, sexually transmitted diseases (STDs) and psychosomatic and social problems Adolescent girls form a group exposed to the possibility of being unsafe not only with respect to their social status but also in relation to their health Puberty mean growth from childhood stage to adolescence stage : This Growth is the result of the concerted effect of a complex network of many regulatory factors with varying interactions In females, the normal start of puberty ranges from 8 to 13 years of age, and it is marked by the development of breast buds under the areola; this step is also called thelarche and represents the Tanner Stage B2. In the sequence of events, the thelarche is followed by pubic and axillary hair growth, known as pubarche; in the meantime, growth velocity starts to increase between stage 2 and 3, reaching a peak in stage 4, when the menarche may appear Menstruation although in natural physiological process often associated with misconceptions and the way a girl gets to know about it can lead to a good or bad perception regarding menstruation. Increased knowledge about menstruation from childhood may increase safe practices and may help in eliminating the suffering of millions of women Inadequate menstrual hygienic practices can harmfully affect the health and can lead to reproductive tract infections, chronic pelvic pain, dysmenorrhea and even infertility The onset of puberty, in addition to the rate of maturation, appears to be dependent on heredity and the environment. The age at menarche of identical twin sisters is within 1-2 months of each other, whereas in dizygotic twins there is about a years difference. In general, girls in poor countries have later menarche than in countries with better socioeconomic conditions .
Age at menarche and breast development are clinically easier to assess, data regarding female puberty is significantly more abundant than male data .
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Age groups
- Child
- Study population
- Adolescent girls in governmental preparatory schools at Abnub district
Key inclusion criteria (1 listed)
- Adolescent girls in preparatory schools in Abnub district
Key exclusion criteria (1 listed)
- Married girls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upgrade awareness of adolescent girls during puberty to improve their reproductive health
Time frame: 2years
questionnair will be prepared to assess this outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Puberty Changes and Menstrual Hygiene, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aml tharwat Said (01022525017, eshoamola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upgrade awareness of adolescent girls during puberty to improve their reproductive health (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.