| CTRI Number |
CTRI/2024/07/071377 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of awareness about Menstrual Health and Patterns of Practices followed by college going girls |
|
Scientific Title of Study
|
A study of Knowledge ,Attitude And Practices of Menstrual Health and Pattern of Practices followed for Menstrual Health through siddha treatment among college going girls in
Perambalur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Bhavatharani |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Chennai -47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9361947973 |
| Fax |
|
| Email |
bhavatharanipugazh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17, Department of Kuzhanthai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Chennai -47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshi Sundaram |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17, Department of Kuzhanthai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Chennai -47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Tambaram sanatorium, Chennai- 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Chennai -47 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Bhavaratharani |
Colleges in Perambalur |
1.Annai Ayesha Arts and science College for Women,valikandapuram,Perambalur.
2.Thanthai Roever Institute of Agriculture and Rural Development, Valikandapuram, Perambalur.
3.Sri Saradha College for Women,Siruvachur,Perambalur.
4.Thanthai Hans Roever College,(AUTONOMOUS),Perambalur.
Perambalur
TAMIL NADU |
9361947973
bhavatharanipugazh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| ANNAI AYESHA ARTS AND SCIENCE COLLEGE FOR WOMEN-NOC |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA CHENNAI-600 047 |
Approved |
| sri saradha college for women-noc |
Approved |
| Thanthai Hans Roever Arts and Science College -NOC |
Approved |
| Thanthai Roever Institute Of Agriculture and Rural Development -NOC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstrual health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
All college going females in the age group between17 years and 19 years |
|
| ExclusionCriteria |
| Details |
Women who have not attained menarche
Those who are not willing to participate the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study of Knowledge ,Attitude and Practices of menstrual health among college going girls in perambalur will be analyzed. The pattern of practices followed for menstrual health by college going girls in perambalur will be analyzed and summarized. |
Data collection 4 months
Data analysis 1 month
Minor project submission and journal communication 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="287"
Sample Size from India="287"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="287" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
INTRODUCTION:
Adolescence is the
transitional period during which a child matures into an adult. Ascribed to the
immaturity of the hypothalamo-pituitary-ovarian axis, menstrual cycle
disturbances are quite common during this phase of life. Menstruation-related
problems contribute to college absenteeism and can significantly add to the
problems faced by adolescents and their families during this sensitive and
difficult phase of development. Also, menstrual problems can be symptoms of
certain conditions like polycystic ovarian syndrome and endometriosis, which if
undiagnosed and untreated may have profound implications in both the
reproductive and general health of women. It has been shown that a society’s socioeconomic
status can have an influence on the age of menarche as well as the prevalence
of menstrual irregularities in the population. The World Health Organization
(WHO) defines “adolescents as individuals between 10- 19-year age group and
“youth between 15-24-year age group. These two overlapping age groups are
combined in the group “young peopleâ€, covering the age range of 10-24 yearsâ€.
OBJECTIVE:
To assess
Knowledge, Attitude and Practices of menstrual health among college going girls
in Perambalur. To assess pattern of practices followed for menstrual health by
college going girls in Perambalur.
STUDY DESIGN:
This is an observational study with a duration of 6 months
which includes 287 women with the age group between 17 years and 19 years in college going girls in perambalur. The Participants will be selected by lottery method
from 6 colleges which include Government and Private school in Perambalur. Data
will be collected by visiting the college using a validated standardized
questionnaire after getting proper consent from the participants using an
informed consent form and properly explaining the study through an information
sheet .women who not attained menarche will be excluded from the study. OUTCOME: Study of Knowledge, Attitude and Practices of menstrual health among college going girlsin Perambalur will be analyzed. The pattern of practices followed for menstrual health by college going girls in Perambalur will be analyzed and summarized RESULT: The result will be statistically analyzed and
reported.
KEY WORDS: Menstrual health, menstrual practices, perambalur
|