| CTRI Number |
CTRI/2024/07/070718 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of painful menstruation and premenstrual syndrome on daily academic performance and its relationship with Body Mass Index among college going students
A cross Sectional study |
|
Scientific Title of Study
|
Impact of dysmenorrhea and premenstrual syndrome on academic activities and its association with Body Mass Index among college students
A cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nida Zafar |
| Designation |
Research student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy School of allied health science Galgotias University
Greater Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6398355352 |
| Fax |
|
| Email |
nidazafar8490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nida Zafar |
| Designation |
Research student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy School of allied health science Galgotias University
Greater Noida
Uttar Pradesh
UTTAR PRADESH
203201
India |
| Phone |
6398355352 |
| Fax |
|
| Email |
nidazafar8490@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanghamitra Jena |
| Designation |
Assistant professor |
| Affiliation |
Galgotias university |
| Address |
Department of Physiotherapy School of allied health science Galgotias University
Greater Noida
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9776961858 |
| Fax |
|
| Email |
sanghamitra.bpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy School of allied health science
Galgotias University
Greater Noida
District Gautam Buddha Nagar
Uttar Pradesh
203201
India |
|
|
Primary Sponsor
|
| Name |
Nida Zafar |
| Address |
Department of physiotherapy
School of allied health science
Galgotias University
Greater Noida
UP |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nida Zafar |
Galgotias University |
E-003
Department of physiotherapy
Galgotias University
Greater Noida
UP
Gautam Buddha Nagar
UTTAR PRADESH |
6398355352
nidazafar8490@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Participants should be within the age range of 18 to 25 years old
Participants must be willing to openly discuss and share their experiences related to dysmenorrhea
The study will include college students |
|
| ExclusionCriteria |
| Details |
Individual outside the age range of 18 to 25 years old
Participants who are not currently enrolled in college or institutions
Participants with significant health issue unrelated to dysmenorrhea that may impact their ability to participate
Students who were found to be amenorrhoeic pregnant within six months postpartum or currently lactating after being asked were excluded from the study
Participants unwilling to openly discuss and share their experiences |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Dysmenorrhea severity questionnaire
Academic activities
Body Mass index.
|
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="357"
Sample Size from India="357"
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)
|
26/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
Here in this study we going to check the impact of dysmenorrhea and premenstrual syndrome on academic activities, whether it create a negative impact or not on academic activities of female college students Here we are also going to check whether there is any association between dysmenorrhea and Body Mass Index by measuring the BMI through height and weight and checking the severity of dysmenorrhea at the same time. |