| CTRI Number |
CTRI/2022/05/042827 [Registered on: 26/05/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Physiotherapy (Pilates exercises))] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga and core strengthening exercises on period pain in young females |
|
Scientific Title of Study
|
Effect of yoga and Pilates exercises on primary dysmenorrhea in young females |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHABNAM JOSHI |
| Designation |
CHAIRPERSON |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
ROOM NO-02,DEPARTMENT OF PHYSIOTHERAPY,GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
HARYANA,125001,INDIA
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHABNAM JOSHI |
| Designation |
CHAIRPERSON |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
ROOM NO-02,DEPARTMENT OF PHYSIOTHERAPY,GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
HARYANA,125001,INDIA
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ALKA PAWALIA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY,GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR
HARYANA,125001,INDIA
Hisar
HARYANA
125001
India |
| Phone |
9568349944 |
| Fax |
|
| Email |
alkapawalia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self (BABITA KUMARI)MPT Student,VPO Mangali dhani jattan dist and tesh Hisar,Haryana-125001 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY GURU JAMBHESHWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR,HAYANA,125001 |
| Type of Sponsor |
Other [[UNIVERSITY]] |
|
|
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 |
| BABITA KUMARI |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY HISAR |
OPD, Room no -04,DEPARTMENT OF
PHYSIOTHERAPY,
GURU JAMBHESHWAR
UNIVERSITY OF
SCIENCE AND
TECHNOLOGY, HISAR
Hisar
HARYANA
Hisar
HARYANA |
8053569973
babita676@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pilates exercises |
Pilates exercises like Shoulder bridging first exercises taught to Pilates beginners show how to use abdominals muscles, gain core strength,strenghtening glutes muscles and others exercises like single leg kick prone, side lying kick, single leg circles, single leg stretch ,Roll up and plank for core strength improving.
Simple yet effective exercises for strengthening the often weakened muscles. It also helps develops control of the core muscles. This exercise program will be performed 3 days a week with 10 repitations of 3 sets with 30 sec break in between the sets. The entire program will last for 4 weeks
|
| Intervention |
yoga therapy |
The intervention consists of 8 postures poses from the following categories will be used -Supine,prone,seated,forward bend, Backward bend. Before doing yoga Bhramari pranayama for 3-5 minutes will be done by the subjects
The yoga program will be performed 3 days a week with 10 repitations having 3 sets and 30 sec in between the sets. During yoga session importance of yoga asana will be stressed. The entire program will lasts for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Age group : 18-30 years females
Moderate to severe pain intensity on NPRS SCALE
Females with regular menstrual cycles
Individual with BMI (18.5-29.9 Kg/m2)
Able to perform exercises. |
|
| ExclusionCriteria |
| Details |
Age should not be less than 18 and more than 30 years
Secondary dysmenorrhea females
Acute or chronic pelvic pathology
Subjects having regular exercise or sports activities
Who cannot perform exercises?
Not willing to participate in the study
Being under medication/steroids or therapy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale score for pain |
Outcomes measured at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Premenstrual syndrome scale score for selection criteria of primary dysmenorrhea
WaLiDD Scale score for quality of life
Perceived stress scale score for stress |
Outcomes measured at baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
31/05/2022 |
| 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="1"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet ,will be done after the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Email of the study investigators
- For how long will this data be available start date provided 01-10-2022 and end date provided 01-02-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
BACKGROUND: Dysmenorrhea comes from Greek word means painful menstrual cycle .It also defines as the painful cramps in the abdominal area during the menstrual cycle. Dysmenorrhea is the lower abdominal or pelvic pain that radiate to the lower back and the thighs. Dysmenorrhea in young adults is usually primary or can be called as functional as cramping pain in the lower abdomen occurring just before or during the menstruation. The Secondary dysmenorrhea is with an existing pelvic disease such as endometriosis which also includes menses pain. Various yoga asana have also been proven to be beneficial in decreasing the various symptoms related to primary dysmenorrhea and Pilates exercise as a combination of strengthening the core also helps in reducing the condition. AIM: To compare the effect of yoga and Pilates exercises on primary dysmenorrhea in young females. PROCEDURE: The baseline data is taken using the Premenstrual syndrome scale questionnaire , Numeric pain rating scale, the perceived stress scale and the working ability, location, intensity, days of pain, dysmenorrhea (WaLiDD) score scale. The study has two groups one is yoga and Pilates exercises, both the group has treatment protocol of 3 days a week for 4 weeks in which the selected exercises are performed on the subjects for 30 minutes with the break included. Present study aimed at find the effect of different yoga posture with the form of bhramari pranayama and the Pilates exercises on primary dysmenorrhea in young females and to relieve pain, improve quality of life and lesser the stress. so at last we compare both the treatment protocol of the two groups as recruited in the study and which protocol is effective in between the two groups. |