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CTRI Number  CTRI/2025/08/093609 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Find out the efficacy of comprehensive Menstrual symptoms scale in adolescent girls on menstrual problem 
Scientific Title of Study   Efficacy of comprehensive Menstrual symptoms scale (CMSS) on menstrual problem among adolescent girls in selected school in Wanadongri 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prachi B Falke 
Designation  Post graduate student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of obstetrics and gynecology nursing, Ground floor, SRMMCON Building, Sawangi Meghe Wardha MAHARASHTRA 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9860118751  
Fax    
Email  falkeprachi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bali Thool 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of obstetrics and gynecology nursing, Ground floor, SRMMCON Building, Sawangi Meghe Wardha MAHARASHTRA 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9975267182  
Fax    
Email  bnthool@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bali Thool 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of obstetrics and gynecology nursing, Ground floor, SRMMCON Building, Sawangi Meghe Wardha MAHARASHTRA 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9975267182  
Fax    
Email  bnthool@rediffmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Swaangi Meghe, Wardha, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Reserch 
Address  Sawangi Meghe Wardha, India 442001 
Type of Sponsor  Private medical college 
 
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 
Prachi Falke  Mahatma Gandhi English Medium High School & Junior College, Wanadongri  Y.C.C.E. Campus, Class 10th, 11th, 12th, Room NO 8, Room No 9, Room No 10, Wanadongri, Nagpur 441110
Nagpur
MAHARASHTRA 
9021361098

falkeprachi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Datta Meghe Institute Of Higher Education And Reserch   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menstrual problem among adolescent girls  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  1.Adolescent girls (12-19years) who were studying in selected school.
2.Adolescent girls (12-19years) who were willing to participate in this study.
3.Adolescent girls (12-19years) who were present at the time of study.
 
 
ExclusionCriteria 
Details  1.Adolescent girls who are not willing to participate.
2.These are PCOD, Pre menstrual Syndrome, Menstrual irregularity and amenorrhea
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of comprehnsive Menstrual symptoms scale (CMSS)  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/09/2025 
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 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  

Abstract

Introduction

Adolescence is a distinct and dynamic phase of an individual. It is a transitional phase of growth and development between childhood and adulthood and is characterized by spurts of physical, mental, emotional, and social development. WHO considers “adolescence” to be the period between 10 and 19 years of age which generally encompasses the time from the onset of puberty to the full legal age. Adolescence is defined in India’s draft youth policy as a person aged 13 to 19.

 

Background

The concept of women’s health has a greater scope. In terms of women’s health, the health of the country where they live actually represents the health of the country as a whole. Women are the primary breadwinners, educators and caretakers of the next generation. They are the centre of our society. Our destiny lies with the well-being of women’s health, and we need to do everything we can to ensure that it is improved. The onset of menstruation signifies that a girl has stepped across a biological threshold into puberty.

 

Objective

1.   To validated comprehensive Menstrual symptoms scale (CMSS) on menstrual problem among adolescent girls.

2.   To assess the efficacy of comprehensive Menstrual symptoms scale (CMSS).

 

Methodology

Quantitative research approach,  A Pre-experimental one group pre-test post-test research design will be used for this study. (control and experimental group)

 

Conclusion

In conclusion, this study aims to systematically assess the impact of a Nursing intervention program regarding comprehensive menstrual symptom among adolescent girls. By addressing variations in clinical practices and the need for a standardized approach, the research endeavours to contribute valuable insights to the field of menstruation.


 
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