| CTRI Number |
CTRI/2024/01/061748 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of breathing exercise in menstrual pain |
|
Scientific Title of Study
|
Effectiveness of Diaphragmatic Breathing on Pain Level in Primary Dysmenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima Samna Nisar |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
Yenepoya physiotherapy department, Kinya, Derlakatte, 6th floor, Pharmacy block
Yenepoya Physiotherapy OPD, 7th floor, opd 7 Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09483040273 |
| Fax |
|
| Email |
fathimashamna1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sivakumar |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
Yenepoya Physiotherapy Department, Yenepoya Deemed to be University, Kinya, Derlakatte Mangalore
6th floor, Physiotherapy block
Yenepoya Physiotherapy OPD, YMCH, 7th floor OPD 7, Derlakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09483040273 |
| Fax |
|
| Email |
mrsivakumar@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sivakumar |
| Designation |
associate professor |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
Yenepoya Physiotherapy department Kinya Derlakatte Mangalore
6th floor Physiotherapy block
Yenepoya Physiotherapy OPD, YMCH, 7th floor, OPD 7, Derlakatte, Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09483040273 |
| Fax |
|
| Email |
mrsivakumar@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, 6th floor Physiotherapy block, Kinya, Derlakatte, Mangalore |
|
|
Primary Sponsor
|
| Name |
Fathima Samna Nisar |
| Address |
post graduate student at yenepoya physiotherapy college kinya
derlakatte mangalore 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 |
| Fathima Samna Nisar |
Yenepoya medical college hospital |
physiotherapy department, 6th floor, Kinya, Derlakatte
Dakshina Kannada
KARNATAKA |
09483040273
fathimashamna1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diaphragmatic breathing exercise and moist heat application |
diaphragmatic
breathing exercise -
it will be done with 3 seconds of inhalation
followed by 4 seconds of exhalation, and moist heat application (Temperature: 50°-60°C)
twice a day for 20 minutes and during the first 5 days of the menstrual cycle |
| Comparator Agent |
Moist heat application |
apply moist heat (Temp: 50°-60°C) twice a day for 20 minutes during first 5 days of the cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Subjects with moderate to severe pain
Regular menstrual cycle |
|
| ExclusionCriteria |
| Details |
Subjects who take pain medications
Any underlying gynecological, cardiovascular, musculoskeletal or endocrinological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain will be measured using Numerical Pain Rating Scale |
7 points (pre, post and for 5 days after intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain & Disability using Shortform McGill pain questionnaire |
at baseline & at completion of the study (3 months) |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
27/01/2024 |
| 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="1"
Months="0"
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
|
This study focuses on determining the effectiveness of diaphragmatic breathing exercise on pain level in primary dysmennorhea. Samples will be divided into intervention and control group. The samples in the intervention group will be asked to do diaphragmatic breathing exercise along with moist heat application and control group will be asked to do only moist heat application for 5 days during the beginning of menstrual cycle and will be assessed after 3 months |