MenstruationsNCT06818123
Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis
A study testing Education Intervention along with the doctor's consultation in people with Menstruations and Menstruation Hygiene, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
Trial summary
Proper menstrual hygiene knowledge and practices are crucial among women. People of urban slum's areas have no or less knowledge and practices of Menstruation hygiene due to low socio-economic status. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruations, Menstruation Hygiene, Hygiene Practices and Knowledge
- What is being tested?
- Education Intervention along with the doctor's consultation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2025to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Woman age in between 15-45years of age
- Those who used reusable items for menstruations
- Those who are willing to participate voluntarily will be included in the study
Who cannot join
- Participants who are suffering from any serious medical condition.
- live in other than slums area of Karachi will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sana S Sheikh, MSc. MPH contact
Pakistan1 site
SINA Health Education and Welfare Trust
Karachi, Sindh, 74800
Hina Sharif, Pharm-D,MBA,MSPH, 03332109679, hina.sharif@sina.pk
Sana S Sheikh, Msc.,MPH, sanshf4@gmail.com
About this study
Official title: Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis.
Proper menstrual hygiene knowledge and practices are crucial among women. People of urban slum's areas have no or less knowledge and practices of Menstruation hygiene due to low socio-economic status. This study helps in Improving menstrual hygiene knowledge and practices and can empower individuals to manage their periods with dignity and comfort. This study also contributes in creating a more open and supportive environment for menstruation by addressing stigma and misconception. The study also helps in reducing the risk of reproductive tract infections.
- Conditions
- Menstruations, Menstruation Hygiene, Hygiene Practices and Knowledge, Knowledge Gaps, Social Stigma
- Being tested
- Education Intervention along with the doctor's consultation, Control group with doctor's consultation only
- Keywords
- Hygiene Practice, Slums Area, Knowledge and practices, Knowledge Gaps, Poor Hygiene, Menstruation Hygiene
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Intervention along with the doctor's consultationOther
This educational intervention will assess the improvement menstrual hygiene knowledge and practices among women at slums who are illiterate and can empower individuals to manage their periods with dignity and comfort.
Control group with doctor's consultation onlyOther
Baseline Knowledge will be assessed in this arm about the menstruations hygiene and practices.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Education Intervention along with the doctor's consultation Receives: Other: Control group with doctor's consultation only |
| Intervention | Experimental | Those who will be under the baseline screening in term of knowledge, will then treated as interventional arm and interventional will be given to them. Receives: Other: Education Intervention along with the doctor's consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Menstruations Hygiene knowledge
Effectiveness of educational intervention of menstruation hygiene among participants
Measured: one month
Secondary outcomes (2)
Reduction in vaginal infection
Recurrent Infection such as yeast infection, discomfort, itching, other related infection.
Measured: one month
promoting better self-esteem and confidence
Participants who is taking the education session and counselling, adapt the good women hygiene
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SINA Health Education and Welfare Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818123
- Sponsor's protocol ID
- 0006
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis.
- ClinicalTrials.gov ID
- NCT06818123
- Acronym / sponsor ID
- 0006
- Conditions
- Menstruations, Menstruation Hygiene, Hygiene Practices and Knowledge, Knowledge Gaps, Social Stigma
- Keywords
- Hygiene Practice, Slums Area, Knowledge and practices, Knowledge Gaps, Poor Hygiene, Menstruation Hygiene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SINA Health Education and Welfare TrustUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
Proper menstrual hygiene knowledge and practices are crucial among women. People of urban slum's areas have no or less knowledge and practices of Menstruation hygiene due to low socio-economic status. This study helps in Improving menstrual hygiene knowledge and practices and can empower individuals to manage their periods with dignity and comfort. This study also contributes in creating a more open and supportive environment for menstruation by addressing stigma and misconception. The study also helps in reducing the risk of reproductive tract infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: Control group with doctor's consultation onlyEducation Intervention along with the doctor's consultation |
| Intervention | Experimental | Other: Education Intervention along with the doctor's consultationThose who will be under the baseline screening in term of knowledge, will then treated as interventional arm and interventional will be given to them. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Woman age in between 15-45years of age
- Those who used reusable items for menstruations
- Those who are willing to participate voluntarily will be included in the study
Key exclusion criteria (2 listed)
- Participants who are suffering from any serious medical condition.
- live in other than slums area of Karachi will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education Intervention along with the doctor's consultationThis educational intervention will assess the improvement menstrual hygiene knowledge and practices among women at slums who are illiterate and can empower individuals to manage their periods with dignity and comfort. | Other | Intervention |
| Control group with doctor's consultation onlyBaseline Knowledge will be assessed in this arm about the menstruations hygiene and practices. | Other | Control Arm |
Primary outcome
Improved Menstruations Hygiene knowledge
Time frame: one month
Effectiveness of educational intervention of menstruation hygiene among participants
2 secondary outcomes
Reduction in vaginal infection
Time frame: one month
promoting better self-esteem and confidence
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
Sana S Sheikh, MSc. MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention along with the doctor's consultation in people with Menstruations and Menstruation Hygiene, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hina Sharif, Pharm-D, MBA, MSPH (+922136943376, hina.sharif@sina.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Menstruations Hygiene knowledge (time frame: one month). 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 10 Feb 2025.