| CTRI Number |
CTRI/2024/09/073416 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Menstrual Hygiene Awareness among adolescents and their Knowledge, Attitude, and Practices. |
|
Scientific Title of Study
|
A study on Menstrual Hygiene Awareness among adolescents & their Knowledge, Attitude, and Practices (KAP)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Pandey |
| Designation |
P.hD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8299143062 |
| Fax |
|
| Email |
shikhapandey08062001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Tewari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090029260 |
| Fax |
|
| Email |
pgtpriya55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi, Uttar Pradesh, India-221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India- 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shikha Pandey |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shikha Pandey |
Banaras Hindu University |
Sir Sundar Lal Hospital, Vikriti Vigyan OPD, Room No. 23 Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India- 221005
Varanasi
UTTAR PRADESH |
8299143062
shikhapandey08062001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, Varanasi, Uttar Pradesh- 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female Adolescents and Menstrual Hygiene |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Teaching Awareness programme will be provided on Menstrual Hygiene Management. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
1. School-going adolescents are included in the
sample between 13 to 17 years old.
2. Adolescents who attained menarche.
3. Adolescents willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Adolescence who did not attain menarche
2. Adolescents who are not willing to
participate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adolescent girls will be aware of menstrual hygiene and will be able to maintain their periods healthily. They will understand myths regarding menstruation and be mindful of good sanitary disposal techniques that can impact our environment. |
30 days with three follow-ups in a single school and this will be repeated in four different schools. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adolescent girls will get a good quality of life with healthy menstruation. |
Quality of life will be assessed before and after the 30-day trial in a single school and this will be repeated in four different schools. |
|
|
Target Sample Size
|
Total Sample Size="310"
Sample Size from India="310"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menstruation is a very important everyday challenge for adolescents in India. Menstruation’s onset brings a new stage in adolescents’ lives as well as new vulnerabilities. While having their period, many adolescent girls experience stigma, bullying, and social exclusion. Around the world, 1.8 billion people menstruate each month. These millions of Girls and women are unable to control their periods respectably and healthily. Menstrual morbidities must be addressed in the early stages of adolescence. The ideal menstrual health education program would teach students to think about the relationships between information, knowledge, and improved human health. It has an impact on community involvement and school attendance. Interventions related to menstruation hygiene and health may help remove these barriers. They not only satisfy the unmet need for menstrual hygiene products, but they also uphold dignity, boost self-esteem, and support sexual and reproductive health, especially in adolescents.
|