| CTRI Number |
CTRI/2024/04/066168 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knowledge, Attitudes, And Practices of Menstrual Hygiene Among School Going Adolescent Girls |
|
Scientific Title of Study
|
Knowledge, Attitudes, And Practices of Menstrual Hygiene Among School Going Adolescent Girls - A Cross-Sectional Survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshitha S M |
| Designation |
3rd year UG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital |
| Address |
Department of kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalagodu Post Mysore Road Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
8050821181 |
| Fax |
|
| Email |
harshithasm2002@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Reena K |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital |
| Address |
Department of kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalagodu Post Mysore Road Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
9480478639 |
| Fax |
|
| Email |
drreenakulkarni@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Harshitha S M |
| Designation |
3rd year UG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital |
| Address |
Department of kaumarabhritya
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalagodu Post Mysore Road Bengaluru
Bangalore KARNATAKA 560074 India |
| Phone |
8050821181 |
| Fax |
|
| Email |
harshithasm2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Aurvedic Sciences (CCRAS)
61-65, Institutional Area, Opp. D Block
Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Aurvedic Sciences CCRAS |
| Address |
61-65, Institutional Area, Opp. D Block Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Government funding agency |
|
|
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 Reena K |
Sri Dharmastala Manjunatheshwara Ayurveda Hospital Bengaluru |
Department of kaumarabhritya
Anchepalya Kumbalagodu Post Mysore Road Bengaluru Bangalore KARNATAKA |
9480478639
drreenakulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstrual Cycle |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
Female students from 12 to 17 years studying in various schools of Kumbalagodu town |
|
| ExclusionCriteria |
| Details |
Girls who did not attain menarche |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improved knowledge and attitudes towards menstruation and better menstrual hygiene practicein adolescent school girls
|
1st month- preparing proforma, contacting various schools, processing CTRI registration
2nd month: registration of the participants and conducting survey followed by awareness talk
3rd month: post analysis, daa entry, statistical analysis, report preparation and submission of the research report, publication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The awareness (knowledge) about menarche and their sources of information before its onset
The prevailing practices for menstrual hygiene among adolescent girls
The restrictions which were practiced by adolescent schoolgirls during menstruation
The association of awareness of menstruation before menarche and practices for menstruation hygiene with educational status of respondents and their mothers
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
06/05/2024 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 visible manifestation of cyclic physiologic uterine bleeding due to shedding of endometrium, under the influence of hormones mainly through Hypothalamo-pituitary-ovarian axis. Menarche occurs between 11 and 15 years with a mean of 13 years, and continues at intervals of 21-35 days. The duration of menstruation is about 4-5 days and amount of blood loss is 20-80ml with average of 35ml.Though it is physiological, it is considered as inauspicious, unclean practice in Indian context. Menstrual hygiene management is about using a clean menstrual management material to absorb or collect menstrual blood, that can be changed in privacy as often as necessary for entire menstrual period, using soap and water for washing body as required, having access to safe and convenient facilities to dispose of used materials.40% and 45% of adolescent girls have poor knowledge and unsafe hygiene practices of menstruation.The main hindrance in developing countries is the lack of facilities of WASH (water, sanitation, and hygiene), proper information, suitable environment, support, which ultimately affects their basic human rights to education, health, and privacy. Such unsafe practices are associated with reproductive morbidities such as genital tract infections, urinary tract infections, and bad odour. Vast information gap exists among adolescent girls regarding prior awareness about menstruation and hygiene.Lack of knowledge and skills of mothers to communicate and educate their daughters regarding menstruation and hygiene practices adds to issue. Further, misconceptions on menstruation results in faulty practices. Hence to bridge the gap, impart proper awareness at right time escalate safe practices, mitigates suffering and aid in reducing chronic pelvic pain, dysmenorrhea, infertility and cervical neoplasia. This study is planned to explore knowledge, attitude and current practices on menstrual hygiene among adolescent girls in and around Kumbalagodu, a small town situated in the outskirts of Bengaluru with estimated population around 13,900. Primary objective: To explore the knowledge, attitudes, status of hygiene and practices regarding menstruation among adolescent school girls Secondary objective: 1. To assess the awareness (knowledge) about menarche and their sources of information before its onset; 2. To find out the prevailing practices for menstrual hygiene among adolescent girls; 3. To assess the restrictions which were practiced by adolescent schoolgirls during menstruation; 4. To ascertain the association of awareness of menstruation before menarche and practices for menstruation hygiene with educational status of respondents and their mothers |