| CTRI Number |
CTRI/2024/10/074886 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
To Check Commoness of Menstrual Pain Affects Mental Health and Academic Performance in Females: A Survey Study |
|
Scientific Title of Study
|
Prevalence Of Primary Dysmenorrhea On Mental Health And Academic Performance Among Female Students Of Galgotias University:A survey 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 |
Naina sabreen |
| Designation |
Student |
| Affiliation |
Galgotias university |
| Address |
Department of physiotherapy, Galgotias university yamuna Expy, opposite Buddha international circuit, sector 17A
Greater noida uttar pradesh,plot no 2 Gautam Buddh nagar
Galgotias university yamuna expy, plot no 2 , sector 17A
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7061724482 |
| Fax |
|
| Email |
Nainacat2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naina sabreen |
| Designation |
Student |
| Affiliation |
Galgotias university |
| Address |
Department of physiotherapy, Galgotias university yamuna Expy, opposite Buddha international circuit, sector 17A
Greater noida uttar pradesh,plot no 2 Gautam Buddh nagar
Galgotias university yamuna expy, plot no 2 , sector 17A
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7061724482 |
| Fax |
|
| Email |
Nainacat2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kanchan dixit |
| Designation |
Assistant professor |
| Affiliation |
Galgotias university |
| Address |
Department of physiotherapy, Galgotias university yamuna Expy, opposite Buddha international circuit, sector 17A
Greater noida uttar pradesh,plot no 2 Gautam Buddh nagar
Department of physiotherapy, Galgotias university yamuna Expy, opposite Buddha international circuit, sector 17A
Greater noida uttar pradesh,plot no 2 Gautam Buddh nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7906645610 |
| Fax |
|
| Email |
Kanchan.dixit@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh India 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Department Of Physiotherapy Galgotias University |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Kanchan Dixit |
Galgotias University |
Department of Physiotherapy, B 315
Gautam Buddha Nagar
UTTAR PRADESH |
7906645610
kanchan.dixit@galgotiasuniversity.edu.in |
|
|
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 |
| Healthy Human Volunteers |
Dysmenorrhea |
| Patients |
, (1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1-Female students aged 13-28 years.
2-Students who are university going.
3-Students who experience menstrual pain that meets the criteria for primary dysmenorrhea |
|
| ExclusionCriteria |
| Details |
1-Students with diagnosed pelvic disorder or secondary dysmenorrhea.
2-Individuals unable or unwilling to provide consent for participation in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of PD among female students |
1 Time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effects of PD on
Academic performance & Mental health |
1 Time Study Through questionnare |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/10/2024 |
| 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="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Pain related to menstruation is called dysmenorrhea. It is the menstruation disorder that women report having the most frequently. Over 50% of women who are menstruating have suffering for 1-2 days per month. Lower abdominal cramps before or during the menstrual cycle without any pelvic pathology is known as primary dysmenorrhea(PD). Increased and/or excessive uterine activity as a result of increased prostaglandin production and release is the pathophysiology of primary dysmenorrhea. For female students, dysmenorrhea is a typical reason for missing work and class due to illness. This study aims to identify prevalence among female students of PD on mental health and academic performance . Sample size is 300 and study needs female students with age group of 13-28 years |