| CTRI Number |
CTRI/2023/10/058858 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of physiotherapy exercises for girls with severe menstrual pain |
|
Scientific Title of Study
|
The Effectiveness of therapeutic exercise and physiotherapy health education on pain and quality of life among girls with primary dysmenorrhea - a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhivyasree |
| Designation |
PG student, Masters of Obstetrics and Gynaecology physiotherapy |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
M.P.T OBG classroom, second floor, Mother Theresa Postgraduate and Research Institute of Health Sciences, government of Puducherry institutions, Indira nagar, gorimedu, puducherry
M.P.T OBG classroom, second floor, Mother Theresa Postgraduate and Research Institute of Health Sciences, government of Puducherry institutions, Indira nagar, gorimedu, puducherry
Pondicherry
PONDICHERRY
605013
India |
| Phone |
8608811599 |
| Fax |
|
| Email |
dhivyasreept@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Beulah Jebakani D |
| Designation |
HOD & Associate Professor |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
Cabin 1 (staff room), second floor, Mother Theresa Postgraduate and Research Institute of Health sciences, government of Puducherry Institutions, Indira nagar, gorimedu, puducherry
Cabin 1 (staff room), second floor, Mother Theresa Postgraduate and Research Institute of Health sciences, government of Puducherry Institutions, Indira nagar, gorimedu, puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9585525141 |
| Fax |
|
| Email |
Beulahjebakani@mtpgrihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dhivyasree |
| Designation |
PG student, Masters of Obstetrics and Gynaecology physiotherapy |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
M.P.T OBG classroom, second floor, Mother Theresa Postgraduate and Research Institute of Health sciences, government of Puducherry institutions, Indira nagar, gorimedu, puducherry
M.P.T OBG classroom, second floor, Mother Theresa Postgraduate and Research Institute of Health sciences, government of Puducherry institutions, Indira nagar, gorimedu, puducherry
Pondicherry
PONDICHERRY
605013
India |
| Phone |
8608811599 |
| Fax |
|
| Email |
dhivyasreept@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ethical clearance- department of obstetrics and gynaecology, Indira Gandhi medical college and research institute, Government hospital of Puducherry |
| Self financed |
| Study setting - Barathidasan Government College for Women, muthiyalpet, Puducherry |
|
|
Primary Sponsor
|
| Name |
Dhivyasree |
| Address |
31, middle street, new saram, puducherry |
| Type of Sponsor |
Other [Self financed ] |
|
|
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 |
| Dhivyasree |
Barathidasan government college for women |
Department of commerce, Department of corporate secretariat, Department of Home science, Barathidasan Government College for Women, Mahatma Gandhi road, muthiyalpet, Puducherry
Pondicherry
PONDICHERRY |
8608811599
dhivyasreept@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Barathidasan Government College For Women |
Approved |
| Indira Gandhi Medical college and research institute |
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 |
Routine physiotherapy care/ usual care |
It includes upper limb and lower limb stretching, and relaxation for 20 minutes given for three alternate days a week for 8 weeks |
| Intervention |
Therapeutic exercise |
It includes upper limb and lower limb stretching, strengthening exercise, aerobics, pelvic floor exercises and relaxation for 50 minutes given three alternate days for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried women age of 18 to 22 years with regular menstrual cycle
1.WaLIDD scale score of 5 and above
2. The individuals who had the menstruation cramps of at least 3-5 days (moderate to very severe)
3.Can read and understand English and Tamil language
4.Subjects who are willing to participate in study and able to do exercise.
|
|
| ExclusionCriteria |
| Details |
1.Married women , athlete or girls who are exercising regularly
2.Secondary dysmenorrhea
3.Abnormal or irregular menstrual cycle
4.Motor limitation
5.Women taking ocp or NSAIDS
6. WaLIDD score below 5
6.women taking pain killers |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain - Visual Analog Scale;
Severity of Dysmenorrhoea - WaLIDD scale
|
At baseline, post intervention at the end of 1st and 2nd periods
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Quality of Life Enjoyment & Satisfaction Questionnaire - short Form (Q-LES-Q-SF) |
At baseline, post intervention at the end of 1st & 2nd periods
|
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/10/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
Studies show that there is a positive correlation between primary dysmenorrhea and absenteeism as well as compromised Quality of Life (QOL). Women are using different strategies to overcome the symptoms from using heat, oral contraceptives, NSAIDS, and other home treatment. A study conducted in 2019 in Puducherry shows that primary dysmenorrhea is highly prevalent and it affects the quality of life [11]. There is a need to study the non-pharmacological management strategies for PD to reduce pain and improve students’ quality of life. Various researchers have studied the effect of aerobic exercise, stretching, strength training and relaxation training and dietary supplements to reduce the symptoms of PD. With the high rate of prevalence of primary dysmenorrhea and its impact on QOL and absenteeism, there is a need to determine the magnitude of PD and to know its impact on student’s life and to work on the management of PD for better quality of life and reduce pain and absenteeism. |