| CTRI Number |
CTRI/2025/03/082861 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Exercises and Breathing Exercises with Kinesio Taping in Pre-Menstrual pain |
|
Scientific Title of Study
|
Effect of Pelvic Floor Strengthening and breathing exercises with Kinesio Taping in Pre-Menstrual pain in young females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yamuni bhandari |
| Designation |
PhD Research Scholar |
| Affiliation |
Jayoti Vidyapeeth Womens University |
| Address |
Jayoti Vidyapeeth Womens University, Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122
Jayoti Vidyapeeth Womens University, Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122
Jaipur
RAJASTHAN
303122
India |
| Phone |
8077905869 |
| Fax |
|
| Email |
yamunibhandari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Ankit Bhargava |
| Designation |
Dean/Director |
| Affiliation |
Jayoti Vidyapeeth Womens University Jaipur |
| Address |
Faculty of Physiotherapy and
Diagnostics
Jayoti Vidyapeeth Womens University Jaipur
Vedant Gyan Valley VILL Jharna 303122
Jaipur
RAJASTHAN
303122
India |
| Phone |
9590501545 |
| Fax |
|
| Email |
physioankit01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yamuni bhandari |
| Designation |
PhD Research Scholar |
| Affiliation |
Jayoti Vidyapeeth Womens University Jaipur |
| Address |
Jayoti Vidyapeeth Womens University, Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122
Jayoti Vidyapeeth Womens University, Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122
Jaipur
RAJASTHAN
303122
India |
| Phone |
8077905869 |
| Fax |
|
| Email |
yamunibhandari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jayoti Vidyapeeth Womens University, Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122, India |
|
|
Primary Sponsor
|
| Name |
Yamuni Bhandari |
| Address |
Jayoti Vidyapeeth Womens University Vedant Gyan Valley Vill Jharna Jaipur (Rajasthan) 303122 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ProfDr Ankit Bhargava |
Jayoti Vidyapeeth Womens University Vedant Gyan Valley Vill Jharna Jaipur (Rajasthan) 303122 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yamuni Bhandari |
Jayoti Vidyapeeth Womens University |
Department of Physiotherapy and Diagnostics,Room no.12, Suryansh Arogya Shala, Jaipur
Vedant Gyan Valley VILL Jharna
303122, India
Jaipur
RAJASTHAN |
8077905869
yamunibhandari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy females with Pre Menstrual pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
The subjects will be randomly divided into two groups:Group A-Kinesio taping, pelvic strengthening exercises and breathing exercises. Group b taping and breathing exercises. |
A written consent will be signed by the subjects who fulfils the inclusion criteria. The pain intensity will be checked prior to intervention by numerical Pain rating scale (NPRS) and participants will be instructed to fill the questionnaire before the intervention and then this questionnaire will be again filled in 1.5 months in between the intervention and then on 3 month of intervention. In Group A Kinesio taping will be applied 2 days prior to expected date of menstrual cycle for 4 days and then next taping will be done in next month 2 days prior to menstruation. Thus taping is done once a month for 3 months along with pelvic floor strengthening and deep breathing exercises.In Group B, the taping will be applied 2 days prior to menstruation n kept for 4 days then the procedure is repeated every week till 3 months along with breathing exercises.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Age group 15-30s years
2.Females suffering from pre-menstrual symptoms
3.In Numerical pain rating scale (NPRS) females having 5 or above score
4.Nulliparous females
|
|
| ExclusionCriteria |
| Details |
1.Females having irregular menstrual cycle
2.Underlying conditions related to gynaecological origin
3.Not on any medications
4.Females having any musculoskeletal conditions
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating scale NPRS |
baseline (day0)
week 6
week 12 (final assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pre Menstrual Questionnare |
baseline (day0)
week 6
week 12 (final assessment) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/03/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A Menstrual disorder which is defined as the
presence of painful cramps of uterine origin occurs during menstruation is
called as Dysmenorrhea. Various studies has also shown that pelvic floor muscles
training considerably improves the quality of life of the women, which
consecutively improves their physical, mental and social functioning.Deep breathing exercise that has relaxing effect
can also increase formation of endorphins in the control system. Thus by muscle
relaxation deep breathing exercises can make the patient more comfortable. The purpose of this study was to compare the
effects of Kinesio taping, pelvic floor strengthening exercises and breathing exercises,
that are being clinically applied for menstrual pain and premenstrual syndrome,
to investigate the efficacy taping and PFM exercises as methods for alleviating
menstrual pain and premenstrual syndrome. |