| CTRI Number |
CTRI/2023/01/048955 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation study |
| Study Design |
Other |
|
Public Title of Study
|
To Find the correlation between intensity of pain,level of stress and quality of life with severity of primary Dysmenorrhea in college going girls. |
|
Scientific Title of Study
|
To find the correlation between intensity of pain, level of stress and quality of life with severity of primary dysmenorrhea in college going girls. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shah dolly vadilal |
| Designation |
MPT scholer |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Parul Institute of physiotherapy, parul university, P. O. Limda, Ta. Waghodia, Dist. Vadodara
Parul Institute of physiotherapy,Parul university, limda, waghodia, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7434028496 |
| Fax |
|
| Email |
shahdolly47084@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh parmar |
| Designation |
MPT in community rehabilitation |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Parul Institute of physiotherapy,Parul university, p. O. Limda, waghodia, vadodara
Parul Institute of physiotherapyParul university, limda, waghodia, vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7434028496 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shah dolly vadilal |
| Designation |
MPT scholer |
| Affiliation |
Parul Institute of physiotherapy |
| Address |
Parul Institute of physiotherapy, parul university,limda, waghodia, vadodara
Parul Institute of physiotherapy,Parul university, limda, waghodia, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7434028496 |
| Fax |
|
| Email |
shahdolly47084@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of physiotherapy,Parul university, p. O. Limda, waghodia, vadodara, 391760 |
|
|
Primary Sponsor
|
| Name |
Parul university |
| Address |
Parul university, limda, waghodia,vadodara |
| 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 |
| Dr Dolly shah |
Parul University |
Parul Institute of physiotherapy,parul university,P. O. Limda, Tal:waghodia, vadodara -391760
Vadodara
GUJARAT |
7434028496
shahdolly47084@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for human research ( PU-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DYSMENORRHEA girls |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Age group 18-25 years.
2. Pain start within 6-12 hours before menses.
3. Girls who have pain for at least one or two days after menses.
4. Lower abdominal, pelvic pain, lower back pain, cramps, medial & anterior thigh pain
lasting 8-12 hrs.
5. Regular menstrual cycle.
6. According to the WALIDD score.
7. Subject willing the participate this study. |
|
| ExclusionCriteria |
| Details |
1. Having secondary dysmenorrhea.
2. Having Urogynecologic diseases, metabolic diseases, neuropsychiatric condition.
3. Any pelvic surgery.
4. Abnormal bleeding.
5. Girls taking oral contraceptive pills due to any hormonal problem. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Waildd score( WORKING ABILITY LOCATION AND INTENSITY OF DAYS OF DYSMENORRHEA)
2-PSS- PERCIEVED STRESS SCALE
3- VAS- VISUAL ANALOG SCALE
4- SF 36- short form 36 |
these will be taken at the time of screening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
15/01/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea is one of the common gynaecological condition in young adolescent girls. It affects the daily activities and quality of life (QoL). Most of the girls experience pain and faces different mood swings during phase of menstruation. A few correlation studies have been done on factors associated with dysmenorrhea on BMI-QoL, physical activities, anxiety, and depression with QoL. Also there is less study of correlations, intensity of pain, degree of stress and QoL with severity of primary dysmenorrhea in collage going girls. So the need arise to found the correlation of above factors. |