| CTRI Number |
CTRI/2024/09/073891 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA)
Other (Specify) [yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of relaxation and yoga on primary dysmenorrhea |
|
Scientific Title of Study
|
Effectiveness of Yoga versus Relaxation
Technique on symptoms and quality of life in
Primary dysmenorrhea -A Randomized
Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Nisar |
| Designation |
UG student |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Dr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7045572841 |
| Fax |
|
| Email |
nisarpalak79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Khot |
| Designation |
Assistant professor,Community physiotherapy |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Dr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9130210294 |
| Fax |
|
| Email |
aditi.khot@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Khot |
| Designation |
Assistant professor,Community physiotherapy |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Dr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra.
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9130210294 |
| Fax |
|
| Email |
aditi.khot@pmtpims.org |
|
|
Source of Monetary or Material Support
|
| Dr. APJ Abdul Kalam College Of physiotherapyCommunity Physiotherapy DepartmentDr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Dr. APJ Abdul Kalam College of Physiotherapy |
| Address |
Community Physiotherapy DepartmentDr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra. |
| 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 Palak Nisar |
Pravara Institute of Medical Sciences |
Community Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy,
Pravara Institute of Medical Sciences,
Loni – 413736, Maharashtra.
Ahmadnagar
MAHARASHTRA |
7045572841
nisarpalak79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
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 |
yoga session |
For Yoga:
2 months
5 days during the Menstruation
20 - 25 mins session
Including warm up
Yoga asanas and cool down period
Warm up for 5 mins
head to toe full body streches
Followed by
Matsyasana 3reps 2 set with 10 sec hold duration 5 mins
Balasana 3reps 2 set with 10sec hold
Duration : 5 mins .
Bhadrasana 3reps 2set with 10 sec hold
Duration 5 mins.
For cool down: 5 mins
End session with
Shavasana
hold this asana for 5 mins |
| Comparator Agent |
relaxation techniques |
For Relaxation :
2 months
5 days during the Menstruation
20 mins session
To sit on a chair as comfortably as possible Keep your body loose, light and free.
Be calm and comfortable.
Keep the eye closed.
Avoid stray thoughts .
Avoid extra movements of the body.
During the part of the exercise cycle tense the muscle tightly and hold for slow
count of 5 seconds.
During the relation part of exercise cycle relaxes the muscle quickly and
completely .
let themind relax and appreciate how relaxed the muscle is feeling
for 10 seconds.
Try to keep all other muscles relaxed as during exercise.
As we exercise from head to toe Observe changes like tightness and the
development of light and soothing sensations.
Relax by taking three deep breaths inhaling through nose and exhaling through
mouth after each step Now make the body completely loose, light and free. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
(1) Participants within age group of 19years - 25years
(2) Participants with positive symptoms of Primary Dysmenorrhea
(3) Participants willing to participate in this study.
(4) Participants who are non-athlete
(5) Participants with no history of severe mental or physical condition
(6) Participants with no history of joint motion, muscle and bone disease that reduces the
ability to perform exercise.
(7) Participants having regular menstrual cycle. |
|
| ExclusionCriteria |
| Details |
(1) Participants with known pelvic pathology.
(2) Participants under medication
(3) Participants who are not willing to participate
(4) Participants under going regular exercise.
(5) Participants who are not able to tolerate physical exercise
(6) Participant who have undergone recent surgery.(7) Participants with chronic disease such as diabetes, hypertension, cardiac disease,
infectious disease, reproductive system disease.
(8) Participants who are pregnant
(9) Participants who have undergone gynecological surgery
(10) Participants who are athlete |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-QSF)
(2) Premenstrual Syndrome Questionnaire (PMSQ) |
week 0 and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-QSF)
|
week 0 and week 8 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/09/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
| . Procedure- Protocol is prepared and ethical clearance will be obtained from the IEC and after CTRI registration. All the participants will be included according to the inclusion and exclusion criteria. The informed written consent and demographic data will be taken from participants regarding the procedure prior to the study and 70 participants with age between 19years to 25 years will be included in study. Detailed history will be obtained and pre-assessment for primary dysmenorrhea will be carried out for all the participants for symptoms of primary dysmenorrhea by Premenstrual syndrome questionnaire (PMSQ) and quality of life will be assessed by Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF). The participants will be divided in 2 groups where group A (35 participants) will undergo Yoga and group B (35 participants) will receive Jacobson relaxation technique. All the groups will undergo physical activities mentioned during their menstruation period for 5 days two session a day with adequate rest period. The duration of each session will be 20 minutes. The study will be continued for about for about 2 months. Participants will be reassessed for their symptoms using Premenstrual syndrome questionnaire (PMSQ) and Quality of life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) |
|