CTRI Number |
CTRI/2021/02/031538 [Registered on: 25/02/2021] Trial Registered Prospectively |
Last Modified On: |
12/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Physiotherapy (including YOGA)] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of yoga and exercise on pain, muscle performance, stress and quality of life in primary dysmenorrhea. |
Scientific Title of Study
|
A comparative study of yoga and structured exercises on pain, muscle performance, stress and quality of life in primary dysmenorrhea |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shivani Ahuja PT |
Designation |
Post Graduate student |
Affiliation |
Amar Jyoti Institute of Physiotherapy |
Address |
2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy
Karkardooma, Vikas marg, New Delhi
East DELHI 110092 India |
Phone |
9968370588 |
Fax |
|
Email |
shivani.ahuja50@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jeyanthi S PT |
Designation |
Associate Professor |
Affiliation |
Amar Jyoti Institute of Physiotherapy |
Address |
2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy
Karkardooma, Vikas marg, New Delhi
East DELHI 110092 India |
Phone |
9958158815 |
Fax |
|
Email |
jeyanthi.s@ajipt.org |
|
Details of Contact Person Public Query
|
Name |
Dr Jeyanthi S PT |
Designation |
Associate Professor |
Affiliation |
Amar Jyoti Institute of Physiotherapy |
Address |
2nd floor, Physiotherapy department, Amar Jyoti Institute of Physiotherapy
Karkardooma, Vikas marg, New Delhi
East DELHI 110092 India |
Phone |
9958158815 |
Fax |
|
Email |
jeyanthi.s@ajipt.org |
|
Source of Monetary or Material Support
|
SELF Amar jyoti institute of physiotherapy, Karkardooma, Vikas marg, New delhi-110092 |
|
Primary Sponsor
|
Name |
Amar jyoti institute of physiotherapy |
Address |
karkardooma, Vikas marg, New Delhi-110092 |
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 |
Shivani Ahuja |
Amar jyoti institute of physiotherapy |
2nd floor, Physiotherapy department, Amar jyoti institute of physiotherapy, Karkardooma, Vikas marg, New Delhi - 110092 East DELHI |
9968370588
shivani.ahuja50@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Amar Jyoti Institutional Review Board |
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 |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
Yoga to Group 1 and Structured Exercise to Group 2 |
In this study we will compare yoga and structured exercises which are two alternative methods that can be used to manage symptoms of primary dysmenorrhea. We will be assessing strength of the abdominal muscles using pressure biofeedback unit, muscle power by front power abdominal test, flexibility using sit and reach test, endurance using abdominal static endurance test and beiring sorensen test. We will use short form 36 questionnaire to assess quality of life, visual analog scale to assess pain intensity and perceived stress scale 10 to assess stress levels in the participants with primary dysmenorrhea. Participants in yoga group will perform asanas like uttanpadasana, uttanasana, sasankasana, salabhasana, chakkichalanasana and dhanurasana. Participants in structured exercise group will perform curl ups, pelvic bridging, plank exercises, trunk extension,bilateral knee to chest, hamstring stretching. After the treatment two post tests using the outcome measures mentioned above will be conducted on the third day of second and third menstrual cycle. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Female |
Details |
WaLIDD Score more than or equal to 1.
Only female subjects with regular menstrual cycles (i.e. 25 to 35 days).
Pain intensity of 4 or above in visual analog scale.
Students with only primary dysmenorrhea.
Willing to participate in the study voluntarily by signing informed consent.
Working knowledge of english. |
|
ExclusionCriteria |
Details |
Students who are not willing to participate.
Using pharmacological or non-pharmacological methods for pain relief during study.
Irregular menstrual cycles.
History of regular exercises or yoga 3 days/week.
History of any gynecological disorders or secondary dysmenorrhea .
History of any musculoskeletal/neurological problems like disc prolapse, etc.
History of recent fracture, strain or sprain. |
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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 |
Visual analog scale to assess pain intensity. |
Assessed on Day 3 of first, second and third menstrual cycle. It will be assessed three times. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pressure biofeedback unit
to measure transversus abdominis muscle strength.
Sit and reach test to assess flexibility.
Front power abdominal test to assess muscle power.
Abdominal static endurance test and beiring sorensen test to assess muscle endurance.
Perceived stress scale - 10 to measure stress levels.
Short form 36 questionnaire to assess quality of life. |
Assessed on Day 3 of first, second and third menstrual cycle. It will be assessed three times. |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/03/2021 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Primary dysmenorrhea is defined as painful menses in women with normal pelvic anatomy and regular ovulatory cycles that usually begins during puberty or adolescent phase. Primary dysmenorrhea affects the women at the age of 16-25 years. Menstrual pain starts after 6 to 12 months after menarche, once the cycles are regular. Symptoms last for about 1 - 3 days of menstruation. Primary dymenorrhea is characterized by cramps, aches or dull pain in the supra-pubic region with or without radiation to lower back, abdomen, medial thigh or upper leg. The chief etiological factors as described by previous researches have been psychic and emotional, fatigue, postural defects and weak abdominal muscles. Hollow back and poor abdominal support lead to increased pressure on pelvic organs and a probable impairment of circulation. Therefore, development of the muscles of the abdominal wall is generally recognized because of the role it plays in maintaining a correct body posture and in supporting the organs in the abdominal cavity. Through this study we will try to explore the abdominal muscle strength, power and endurance in women with primary dysmenorrhea. Also in this study we will explore the effect of alternate treatment technique (ie Yoga and structured exercises) to reduce pain, improve muscle performance, and quality of life in primary dysmenorrhea. Subjects will be allocated randomly into two training groups (yoga and structured exercises). Then a pre - test will be performed on the third day of the menstrual cycle before beginning with the intervention. Pre - test will involve testing the levels of pain, muscle performance (strength, power, flexibility and endurance), stress and quality of life. Study involves 3 week long intervention period. Then 2 post tests will be conducted on the third day of second and third menstrual cycles. |