| CTRI Number |
CTRI/2023/08/056438 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises on painful menstruation |
|
Scientific Title of Study
|
Effect of Pilates with relaxation exercises on pain, psychological status and quality of life in young adult females with primary dysmenorrhea- A Pilot 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 |
Dr Yash Pratap |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No E003, Department of Physiotherapy, Galgotias University
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9268504629 |
| Fax |
|
| Email |
yash.pratap@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yash Pratap |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No E003, Department of Physiotherapy, Galgotias University
UTTAR PRADESH
203201
India |
| Phone |
9268504629 |
| Fax |
|
| Email |
yash.pratap@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Sisodiya |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E003, Department of Physiotherapy, Galgotias University
same as above
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9536841270 |
| Fax |
|
| Email |
priyasisodiya173@mail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University,
Plot No 2, Sector 17a, Opposite Buddha International Circuit, Greater Noida, Uttar Pradesh India 203201 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
E003, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opp. Buddha International Circuit, Yamuna Expy, Greater Noida |
| Type of Sponsor |
Research institution |
|
|
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 |
| Priya Sisodiya |
Galgotias University |
Room No E003, Galgotias University, Plot No 2, Sector 17A, Greater Noida, Opp. Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH |
9536841270
priyasisodiya173@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee |
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 |
Hot fomentation
|
All patients in the control group will receive hot fomentation three times per weekly for six weeks. |
| Intervention |
Pilates exercises
Relaxation exercises |
All patients will receive
conventional physiotherapy
treatment. Also the participants in the intervention group will receive all these exercises 1.Single leg stretch
2.Double leg stretch
3.Bridging
4.The roll up
5.The hundred
6.Plank
In Relaxation exercises should be done in sitting.
1.Deep breathing
2.Diaphragmatic breathing
Duration: 6week (35-40min) 3 days/week
They will be told its voluntary and they can withdraw anytime from the study and it won’t affect |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Moderate or severe premenstrual pain or during menses pain measured by WaLLID score
Had moderate and severe depression as measured by Hamilton rating depression scale.
Who have a regular cycle of menstruation (25-30 days) past six month .
Who didn’t take analgesic or taking a maximum of 1 drug.
|
|
| ExclusionCriteria |
| Details |
Were already practicing another exercise like running swimming or fitness center.
Were diagnosis to have PMS and UTI Infection on treatment Were unable to participate in the study due to the health deviations Subject having any history of regular exercises
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS SCORE
WALLID SCORE
Q-LES-Q-SF
HAMILTON DEPRESSION SCALE |
Baseline, 4th week and 6 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/08/2023 |
| Date of Study Completion (India) |
10/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Introduction: Primary dysmenorrhea, also known as menstrual cramps, is a common gynecological condition affecting young adult females. It is characterized by painful menstruation without any underlying pelvic pathology. This condition can significantly impact the quality of life, causing physical discomfort, emotional distress, and negatively affecting daily activities. While pain medications are often used for relief, there is a growing interest in alternative therapeutic approaches like exercise and relaxation techniques. The present pilot study aims to investigate the potential benefits of combining Pilates with relaxation exercises in alleviating pain, improving psychological status, and enhancing the quality of life in young adult females with primary dysmenorrhea. Methods: The pilot study will a small sample of young adult females (n=30) aged 18 to 25 years who were diagnosed with primary dysmenorrhea. Participants were recruited through local clinics and social media platforms. The study design was a single-arm, pre-test, and post-test intervention. The participants underwent an eight-week intervention consisting of twice-weekly sessions of Pilates combined with relaxation exercises. The Pilates exercises will focus on strengthening the core, improving flexibility, and enhancing overall body awareness. The relaxation exercises will include breathing techniques, meditation, and progressive muscle relaxation. Pain intensity, psychological status, and quality of life will be assessed using standardized questionnaires before and after the intervention. Results:After the eight-week intervention, the data will be taken from the participants. The combination of Pilates and relaxation exercises seemed might have a positive impact on pain management, possibly through improved blood circulation, reduced muscle tension, and enhanced mind-body connection. Moreover, the intervention might lead notable improvements in psychological status, as evidenced by reduced anxiety and depressive symptoms. Participant’s feeling with stress related to dysmenorrhea will be assessed. Furthermore, the effects of intervention on the quality of life of young adult females with primary dysmenorrhea. The participants experiences on physical functioning, limitations in daily activities during menstruation, and an overall enhancement in their well-being. These findings might suggest that incorporating Pilates and relaxation exercises into the management of primary dysmenorrhea could have broader implications in promoting a healthier lifestyle and overall wellness for young women.
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