FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menstrual Cycle 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
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

 
Close