| CTRI Number |
CTRI/2025/05/087670 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Effect of Aerobic Exercises, Relaxation Technique and Myofascial Release on sleep quality and Premenstrual Syndrome (PMS) Symptoms among college students in Delhi NCR. |
|
Scientific Title of Study
|
The Impact of Aerobic Exercises, Progressive Relaxation Technique, and Myofascial Release Technique on sleep quality and Premenstrual Syndrome (PMS) symptoms among college students experiencing Premenstrual Syndrome in Delhi NCR. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahanvi Tuteja |
| Designation |
Student |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
8750406315 |
| Fax |
|
| Email |
jaani02aqua@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Kataria |
| Designation |
Associate Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
09654441104 |
| Fax |
|
| Email |
Jyoti.kataria@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanshika Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI
110019
India |
| Phone |
9136001477 |
| Fax |
|
| Email |
vanshikaagarwal@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institute of Physiotherapy, Chandiwala Estate, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019
India |
|
|
Primary Sponsor
|
| Name |
Jahanvi Tuteja |
| Address |
Chandiwala Estate, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Jyoti Kataria |
Banarsidas Chandiwala Institute of Physiotherapy |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Metro Station, Ma Anandmayee Marg, Near Govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi
South
DELHI |
9654441104
Jyoti.kataria@bcip.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banarsidas Chandiwala Institute of Physiotherapy Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Aerobic Exercises
2.Progressive Relaxation Technique
3.Myofascial Release Technique |
1.Aerobic exercises improves oxygen consumption by large muscles of group, and the exercise program includes three components: warm up period, aerobic exercise program and cool down period.
2.Progressive relaxation therapy (PRT) is a method of relaxation that focuses on the mind-body connection. By tightening a specific group of muscles and then relaxing it, it helps the patient to be aware of her body and its physical sensations.
3.Myofascial Release Technique (MRT) is a technique that aims to mobilize soft tissue, increase fascial mobility, reducing adhesions and pain. The technique involves applying slow and continuous pressure directly or indirectly to the fascia layers.
The intervention will take place thrice a week for 2 menstrual cycle. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1)Female of age group between 18-25 years of age.
2)Experiencing premenstrual symptoms for at least 3 months.
3)A score of more than 27 on the PMS Scale.
4)Regular menstrual cycle for 12 months. |
|
| ExclusionCriteria |
| Details |
1.Irregular and infrequent menstrual cycle.
2.Individuals with chronic diseases (e.g., heart diseases, thyroid)
3.Individuals receiving hormone therapy.
4.Pregnant individuals.
5.Involved in athletic activity
6.Taking Pain relieving medication or any other continuous use of medication
7.Individuals with neurological or psychological disorders.
8.Individuals with urinary, genital, endocrinological diseases, gastrointestinal disorders any infectious disease.
9.Individuals who underwent hysterectomy surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pittsburgh Sleep Quality Index (PSQI)
2)Shortened Premenstrual Assessment Form |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Premenstrual syndrome (PMS) is a common condition experienced by women of
reproductive age. It is characterized by a range of behavioural, physical, and
psychological symptoms that occur during the luteal phase of the menstrual
cycle, typically 7 to 10 days prior to the start of menstrual cycle and ends
with the onset of the secretory phase, due to hormonal changes. Premenstrual symptoms might cause several difficulties for women including
impairment in physical functioning and psychological health. This study aims to
evaluate the impact of Aerobic exercises, Progressive Relaxation Therapy (PRT) and
Myofascial Release (MFR) in improving sleep quality and managing PMS symptoms. The findings could
contribute to the development of evidence-based, non-pharmacological strategies
for PMS management, ultimately enhancing overall well-being and academic
success. |