| CTRI Number |
CTRI/2024/11/076697 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An experimental study comparing the effects of gym ball exercise, pressure biofeedback exercise, and deep breathing exercises on pain and function in Parul University college-bound students with primary dysmenorrhea |
|
Scientific Title of Study
|
Effects of Gym Ball exercise versus Pressure Biofeedback exercise along with Deep Breathing exercise on Pain and Function in Primary Dysmenorrhea in Parul University college going Students – An Experimental 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 |
Aishwarya Rathva |
| Designation |
student |
| Affiliation |
Parul institute of physiotherapy, Parul University |
| Address |
Room no. 309, second floor, parul institute of physiotherapy, parul
university, post limda, Waghodia, Gujarat, India
parul university, post limda, Waghodia, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
7622071776 |
| Fax |
|
| Email |
arathva28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nilesh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
Parul institute of physiotherapy, Parul University |
| Address |
Room no. 309, second floor, parul institute of physiotherapy, parul
university, post limda, Waghodia, Gujarat, India
parul university, post limda, Waghodia, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
9913589719 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversityac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nilesh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
Parul institute of physiotherapy, Parul University |
| Address |
Room no. 309, second floor, parul institute of physiotherapy, parul
university, post limda, Waghodia, Gujarat, India
parul university, post limda, Waghodia, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
9913589719 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversityac.in |
|
|
Source of Monetary or Material Support
|
| Parul institute of physiotherapy, at-post-limda, waghodiya, gujarat, pincode- 391760,india
|
|
|
Primary Sponsor
|
| Name |
Aishwarya Rathva |
| Address |
Room no. 309, second floor, parul institute of physiotherapy, parul
university, post limda, Waghodia, Gujarat, India |
| 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 |
| Aishwarya rathva |
parul institute of physiotherapy |
Room no. 309, second
floor, parul institute of
physiotherapy, parul
university, post limda,
Waghodia, Gujarat,
India
Vadodara
GUJARAT |
7622071776
arathva28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
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 |
gym ball exercises |
1.Knee tucks- 10 repetition
2.back extension - 10 repetition
3.Bridge 10 repetition
4.Plank 10 repetition
5.Stability ball crunch
6.Deep breathing exercise 10 repetitions,
total intervention time - 40 minutes,
3 Days a week for 4 weeks |
| Comparator Agent |
pressure biofeedback exercises |
1.Drawing in maneuver 10 repetition
2.Drawing in maneuver with SLR 10 repetition
3.Deep breathing exercise 10 repetition,
total intervention time - 30 minutes,
3 Days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Age between 20 to 25
2.study include girls with primary dysmenorrhea
3.WaLIDD Score Between Moderate to Mild
4.Persistent primary dysmenorrhea of more than 2 months
|
|
| ExclusionCriteria |
| Details |
1.Girls With Secondary Dysmenorrhea
2.musculoskeletal or neurological disorders, chronic low back pain or sacroiliac dysfunction, diabetes, polycystic ovary disease, pelvic infection or pelvic pain and any other pelvic pathologies
3.Subjects using any medications (including hormonal contraception) for at least last 2 months
4.Developing irregular menstrual cycle
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WaLIDD score |
4 weeks, 4 days par week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS |
4 weeks, 4 days par week |
| iii. menstrual distress questionary |
4 weeks, 4 days par week |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
19/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/11/2024 |
| 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 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
|
Primary Dysmenorrhea is the most
prevalent menstrual problem in young females, which affects their daily
activities and Quality of life. Rates are as high as 67% to 90% for Those
aged between 17–24 years. 16–90% of
females of Reproductive age suffer from
Dysmenorrhea with 2–29% having pain severe enough to restrict them to bed Gym ball exercises
include exercises that are performed on a gym ball. The gym ball is
used by trainers in fitness programs and by therapist for injury rehabilitation
and prevention. This is due to an understanding of spinal stabilization and the
role of that it plays in dysmenorrhea. Pressure Biofeedback
units are clinically necessary to evaluate the effects of lumbar stabilization
and are suitable for use with lumbar stabilization exercises. Core strengthening exercises allows the
small intrinsic muscles around the lumbar spine to be conditioned to increase
performance; this training allows the isolation and strengthening of core
muscle groups.The
differences between the thicknesses of these muscles were related to a weakened
local muscle system, resulting in instability and dysmenorrhea. Deep Breathing Exercises (DBE) are
suggested as an alternative source of treatment for primary dysmenorrhea . Relaxation techniques provide us with excellent
methods that can be practiced with awareness anytime at our discretion . One specific respiratory maneuver in breathing is both
popularly and scientifically linked to Deep Breathing Relaxation There have been few studies and technique to improve
the dysmenorrhea but there are very few studies explaining the effect of gym ball
exercise on pain and function in primary dysmenorrhea. There have been few studies and technique to improve
the dysmenorrhea but there are very few studies explaining the effect of pressure
biofeedback exercise on pain and function in primary dysmenorrhea
|