| CTRI Number |
CTRI/2024/03/064720 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out risk factors of pre- menstrual syndrome (PMS) among young girls in selected colleges. |
|
Scientific Title of Study
|
An exploratory survey to identify patterns and predictors of pre- menstrual syndrome (PMS) among young girls in selected colleges of Udupi district, Karnataka |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maelona Elizabeth Michael |
| Designation |
Bsc nursing student |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal |
| Address |
Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
maelonamichael2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjalin Dsouza |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal |
| Address |
department of child health nursing
Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845378098 |
| Fax |
|
| Email |
anjeline.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjalin Dsouza |
| Designation |
Assistant professor |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal |
| Address |
department of child health nursing
Manipal College of Nursing, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
9845378098 |
| Fax |
|
| Email |
anjeline.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
| study will be conducted in Manipal college of nursing, self-financed. |
|
|
Primary Sponsor
|
| Name |
Melona Elizabeth |
| Address |
B.Sc. Nursing student
Manipal College of Nursing, MAHE, Manipal |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DrAnjalin Dsouza |
Manipal college of nursing |
second floor, Department of child health nursing, Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA |
9845378098
anjeline.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Young girls who have been having regular menstruation.
Young girls who were willing to participate in the study
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify patterns of Pre-menstrual syndrome (PMS) among young girls as measured by a questionnaire |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the predictors of Pre-menstrual syndrome (PMS) among young girls as measured by a questionnaire. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Premenstrual
syndrome (PMS) refers to emotional and physical symptoms that regularly occur
in the one to two weeks before the start of each menstrual period. Symptoms
resolve around the time menstrual bleeding begins. Different women experience
different symptoms. Premenstrual syndrome is commonly noted by at least one
physical, emotional, or behavioural symptom, which resolves with menses. Statement
of the problem
An exploratory
survey to identify patterns and predictors of pre- menstrual syndrome (PMS)
among young girls in selected colleges of Udupi district, Karnataka.
Purpose
of the study
The purpose
of the study is to explore patterns and predictors of pre- menstrual syndrome (PMS)
among young girls which will help the health professionals to respond
appropriately to reduce the magnitude of this problem.
Objectives
of the study
i) To
identify patterns of Pre-menstrual syndrome (PMS) among young girls as measured
by a questionnaire.
ii) To
assess the predictors of Pre-menstrual syndrome (PMS) among young girls as
measured by a questionnaire. Plan for Pilot study
The function
of pilot study is to obtain information for improving the project assessing its
feasibility. It will be done among first year students; 20 participants will be
selected.
Ø Plan for data collection
Data from participants will be collected by
administering tools through Google forms after obtaining informed consent |