CClinicalTrials.gg
Not yet recruitingNCT06818123Updated Feb 10, 2025

Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis

An interventional study of Education Intervention along with the doctor's consultation and Control group with doctor's consultation only in Menstruations, Menstruation Hygiene and Hygiene Practices and Knowledge, sponsored by SINA Health Education and Welfare Trust. Not yet recruiting at 1 site in Pakistan. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by SINA Health Education and Welfare Trust · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
15 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Participants who are suffering from any serious medical condition.
  • live in other than slums area of Karachi will be excluded from the study.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Placebo comparator
    Control Arm

    Education Intervention along with the doctor's consultation

    Other: Control group with doctor's consultation only

  • Experimental
    Intervention

    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.

    Other: Education Intervention along with the doctor's consultation

Interventions

  • OtherEducation Intervention along with the doctor's consultation

    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.

  • OtherControl group with doctor's consultation only

    Baseline Knowledge will be assessed in this arm about the menstruations hygiene and practices.

05

What researchers measure

Primary outcomes

  1. Improved Menstruations Hygiene knowledge

    Effectiveness of educational intervention of menstruation hygiene among participants

    Time frame: one month

Secondary outcomes

  1. Reduction in vaginal infection

    Recurrent Infection such as yeast infection, discomfort, itching, other related infection.

    Time frame: one month

  2. promoting better self-esteem and confidence

    Participants who is taking the education session and counselling, adapt the good women hygiene

    Time frame: one month

06

Study locations

1 site
  • SINA Health Education and Welfare Trust
    Karachi, Sindh 74800, Pakistan
    • Hina Sharif, Pharm-D,MBA,MSPH · Contact · hina.sharif@sina.pk · 03332109679
    • Sana S Sheikh, Msc.,MPH · Contact · sanshf4@gmail.com
    • Hina Sharif, Pharm-D,MBA,MSPH · Principal investigator
    • Tooba Seemi, MSc. · Sub investigator
    • Sana S Sheikh, MSc. MPH · Sub investigator
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06818123
Lead sponsor
SINA Health Education and Welfare Trust
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Feb 28, 2025 (estimated)
Primary completion
Mar 31, 2025 (estimated)
Completion
Apr 15, 2025 (estimated)
Last update
Feb 10, 2025

Study contacts

Hina Sharif, Pharm-D, MBA, MSPH
Contact
hina.sharif@sina.pk
+922136943376
Sana S Sheikh, MSc. MPH
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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