| CTRI Number |
CTRI/2021/12/038544 [Registered on: 09/12/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [comparative study ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To Check Effects Of Suryanamskar Against Gym Ball Exercises With K Taping On Pain And Symptoms In women With Painful Menstruation |
|
Scientific Title of Study
|
Effects Of Suryanamskar Versus Gym Ball Exercises With K Taping On Pain And Symptoms In Primary Dysmenorrhea: A Comparative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini Jadhav |
| Designation |
M.P.Th. |
| Affiliation |
D.Y.Patil college of physiotherapy |
| Address |
krishna keval township krishna keval society MNIOP sector iris wing third floor flat no 311 NIBM road Kondhawa
Sant tukaram nagar near YCM hospital third floor
Pune
MAHARASHTRA
411048
India |
| Phone |
87766797566 |
| Fax |
|
| Email |
tejaswinijadhav63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Kulkarni |
| Designation |
Associate Proffesor |
| Affiliation |
D.Y.Patil college of physiotherapy |
| Address |
Dr. D.Y. Patil college of Physiotherapy,Muskuloskeletal department, Third floor, Sant tukaram nagar, pimpri,pune.
Sant tukaram nagar near YCM hospital third floor
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Tejaswini Jadhav |
| Designation |
M.P.Th. |
| Affiliation |
D.Y.Patil college of physiotherapy |
| Address |
krishna keval township krishna keval society MNIOP sector iris wing third floor flat no 311 NIBM road Kondhawa
Sant tukaram nagar near YCM hospital third floor
Pune
MAHARASHTRA
411048
India |
| Phone |
87766797566 |
| Fax |
|
| Email |
tejaswinijadhav63@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y patil college of physiotherapy pimpri |
|
|
Primary Sponsor
|
| Name |
DYPatil College Of Physiotherapy |
| Address |
D.Y.Patil College Of Physiotherapy Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Tejaswini Jadhav |
Dr. D.Y. Patil College Of Physiotherapy |
Dr. D.Y. Patil college of physiotherapy, 3rd floor,Sant tukaram nagar,near YCM hospital,pimpri,411018.
Pune
MAHARASHTRA |
87766797566
tejaswinijadhav63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
K-Tape |
Given on first day within 12 hours |
| Comparator Agent |
Suryanamskar |
Given on fourth day of menses
thrice in a week for two months
progression on day one five repetitions given and with every session one suryanamaskar is added. |
| Comparator Agent |
Swiss ball |
given on fourth day
thrice in a week for two months
10 sec hold 10 repetitions
holds are increased till 30 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1) Age group between 18yrs to 25yrs.
2)Females moderate to severe PD acc. to Mc Gill Pain Questionnaire 3) Pain during last three menstrual cycles
4) Nulliparous women
5) Not taking any other medication or treatment during the intervention.
|
|
| ExclusionCriteria |
| Details |
1) Regular use of NSAIDs during the treatment.
2) Secondary Dysmenorrhea
3) Use of Intrauterine or oral Contraceptives
4) Females doing daily exercises
5) Conception/Pregnancy during intervention.
6) Any gynecological condition such as PCOD.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| menstrual symptom questionnaire |
25 items in the questionnaire
Scoring:type of dysmenorrhea will indicate the order of scoring
if spasmodic the scoring is 1 to 5
if congestive the reverse scoring
primary outcome is taken as preassessment before starting an intervention, second assessment will be taken after second month of menses and thereafter third month of intervention.ie; after 4 weeks and eight weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mc Gill Pain Questionnaire |
above 25 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2021 |
| Date of Study Completion (India) |
23/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
international journal of gynecology and obstetrics
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will be performed on females within age group of 18 years to 25 years with primary dysmenorrhea. the intervention will be start on the first day of menses K- Tape is applied within 12 hours of menses. exercises for both the groups are started on the fourth day of menses. in group A Suryanamskar is given & in group B Swiss ball exercises are given. after one month of intervention MDQ & Mc Gill Pain Questionnaire is given to Check the effect of given intervention Same after second month of intervention and in third month carryover effect will be checked in the participated females. |