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CTRI Number  CTRI/2021/11/037916 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [health education module]  
Study Design  Other 
Public Title of Study   Effect of school based health education on menstrual hygiene in school gong adolescent girls 
Scientific Title of Study   EFFECT OF SCHOOL BASED HEALTH EDUCATION ON MENSTRUAL HYGIENE-AN INTERVENTIONAL STUDY AMONG SCHOOL GOING ADOLSCENT GIRLS 
Trial Acronym  SEMHIA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SITHAL DALAI 
Designation  Post Graduate Student 
Affiliation  MKCG MEDICAL COLLEGE, ODISHA 
Address  Department of Community Medicine, MKCG Medical College, Berhampur
Dalai Niwas. Ankuli high school square. Brahmapur. Ganjam. Odish. PIN 760008
Ganjam
ORISSA
760004
India 
Phone  8763754645  
Fax    
Email  sithal22@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Durga Madhab Satapathy 
Designation  Professor and Head of the Department 
Affiliation  MKCG MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Community Medicine
MKCG MEDICAL COLLEGE
Ganjam
ORISSA
760004
India 
Phone  9861084185  
Fax    
Email  drdurgams65@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SITHAL DALAI 
Designation  Post Graduate Student 
Affiliation  MKCG MEDICAL COLLEGE, ODISHA 
Address  Department of Community Medicine, MKCG Medical College, Berhampur

Ganjam
ORISSA
760004
India 
Phone  08763754645  
Fax    
Email  sithal22@outlook.com  
 
Source of Monetary or Material Support  
MAMATA Health Institute for Mother and Child 
 
Primary Sponsor  
Name  MAMATA Health Institute for Mother and Child 
Address  B-5, Greater Kailash Enclave-II, New Delhi 110048 
Type of Sponsor  Other [Not for Profit Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sithun Patro  MOTHER SAROJINI GIRLS HIGH SCHOOL  industrial estate, Brahmapur, Odisha 760008
Ganjam
ORISSA 		 9438604420

pinuruchi@gmail.com 
SITHAL DALAI  V.V. GIRI GOVT GIRLS HIGH SCHOOL  Giri Rd, Ram Nagar, Brahmapur, Odisha 760005
Ganjam
ORISSA 		 8763754645

sithal22@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
DISTRICT EDUCATION BOARD  Approved 
Institutional Ethics Committee, MKCG Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  participants in normal health condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  baseline knowledge without intervention via health education module  baseline knowledge and practices without intervention via health education module and follow up at 6 months 
Intervention  health education module  health education module developed based on pretest knowledge of the participants and reinforcement per month for 6 months 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  16.00 Year(s)
Gender  Female 
Details  school going adolescent girls going to 8th, 9th and 10th class and those who have attained menarche 
 
ExclusionCriteria 
Details  those who do not give consent/ ascent and
severely ill or uncooperative  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
knowledge level and improvement in practices regarding menstrual hygiene  1 month and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
level of retention of knowledge and the extent of behavioral change with the interval reinforcement  6 month 
 
Target Sample Size   Total Sample Size="324"
Sample Size from India="324" 
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)   27/11/2021 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  data will be shared if anyone contacts the researcher via the email sithal22@outlook.com

  6. For how long will this data be available start date provided 01-04-2022 and end date provided 02-04-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Health education builds knowledge, motivates students to improve and maintain their health, prevent disease and reduce risky behaviors. Due to poor menstrual hygiene management, many girls even drop schooling after primary education. Moreover, they suffer from numerous diseases like anemia and infections which contribute to the morbidity and mortality in their later stages of life.

With this scenario, it would be appropriate to give educational intervention to girls at school level itself. Increased knowledge about menstruation right from childhood may escalate safe practices and may help in mitigating the suffering of millions of women. The present study will be undertaken to explore the level of knowledge, attitudes, status of hygiene and practices regarding menstruation among adolescent school girls and educate them via a concise module developed in local language and to evaluate its impact in knowledge and practices followed after intervention.

 
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