| CTRI Number |
CTRI/2021/04/032569 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Gym ball exercise on dysmenorrhoea.(during menstrual period) |
|
Scientific Title of Study
|
Effect of Gym ball exercise on dysmenorrhoea among nursing students in a selected college at Mangaluru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Azabu |
| Designation |
M.Sc. Student |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Department of Obstetrics and Gynaecological Nursing.
Nitte Usha Institute of Nursing Sciences, Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka.
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
08794291944 |
| Fax |
08242203163 |
| Email |
azabukriibve@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Philomena Fernandes |
| Designation |
Professor |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Department of Obstetrics and Gynaecological Nursing.
Nitte Usha Institute of Nursing Sciences, Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka.
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
9449207845 |
| Fax |
08242203163 |
| Email |
philomena@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Philomena Fernandes |
| Designation |
Professor |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Department of Obstetrics and Gynaecological Nursing.
Nitte Usha Institute of Nursing Sciences, Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka.
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
9449207845 |
| Fax |
08242203163 |
| Email |
philomena@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Self funded and support from NITTE University, Deralakatte, Mangaluru. |
|
|
Primary Sponsor
|
| Name |
Azabu |
| Address |
Nitte Usha Institute of Nursing Sciences, Kotekar Beeri Road, Paneer, Deralakatte, Mangaluru, Karnataka |
| 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 |
| Azabu |
Nitte Usha Institute of Nursing Sciences Girls Hostel. |
Paneer Campus- Dhriti, Unati, Aditi Hostels , Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA |
08794291944
08242203163
azabukriibve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dysmenorrhoea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gym Ball exercise for 3 weeks. |
Gym Ball exercise for 3 weeks, 3 times in a week (Monday, Wednesday and Friday)for 50 minutes. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
1.Residing in nursing hostels at Paneer campus, Mangaluru.
2.Age group of 18-22 years.
3.Suffering from dysmenorrhea with moderate to severe pain based on the Visual analogue Scale.
4.Having regular menstrual cycle (28-30 days) with a duration of 3-6 days.
5.With the history of moderate to severe dysmenorrhoea (for at least 3 times in the past 6 months).
|
|
| ExclusionCriteria |
| Details |
1.Suffering with Gynaecological disorder and undergoing treatment.
2.Under hormonal therapy.
3.With restricted physical activity due to illness.
4.Diagnosed with musculoskeletal or neuromuscular problems.
5.Taking over the counter medications.
6.Using any other alternative therapies (yoga, acupuncture, massage, homeopathy).
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
H1:There will be significant difference between pre and post interventional mean pain score among experimental group.
H2:There will be significant association between the pre interventional pain scores of dysmenorrhea and selected demographic variables.
|
5 Weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hâ‚‚: The mean post interventional pain score in the experimental group will be lower than the post mean pain score in the control group. |
5 weeks. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/04/2021 |
| 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="21"
Months="3"
Days="15" |
|
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
|
Dysmenorrhoea has various physical and mental problems usually lower abdominal pain, lower back pain, dizziness, headache, and fatigue. Especially 50% women of childbearing age suffers from dysmenorrhoea where 45-90% suffers from primary dysmenorrhoea. Gym ball exercise (knee tucks, hamstring curls, and back extension) has been known to relieve pain. Hamstring curls using gym ball helps to strengthen gluteus maximus, gluteus minimus, and Gluteus Medius muscles. It also strengthens the abdominal muscles such as transverse abdominis, internal oblique, and external oblique .Back extension in gym ball builds
strength and stability in lower back, gluteus, and hamstrings. It stretches and
strengthens the core muscles by improving the blood supply, which helps to
reduce the menstrual pain. Knee tucks in gym ball help to strengthen the muscle
around the abdomen, legs, arms, and back region. It also improves balance,
stability, and blood supply which helps to ease menstrual pain. It improves blood supply and nutrient supply to the lower abdomen and lower back region which helps to relieve menstrual cramps. Based upon the findings of existing literature it was realize that there is an opportunity to explore the effectiveness of gym ball exercise on dysmenorrhoea which is one of the less expensive and easy technique to reduce dysmenorrhoea. |