| 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
|
|
|
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
|
|
|
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. |