| CTRI Number |
CTRI/2026/02/104286 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of musculoskeletal and psychological outcomes in breastfeeding and bottle feeding women |
|
Scientific Title of Study
|
Comparison between myofascial trigger points cervical mobility lumbar flexibility psychological well being and sleep quality in breastfeeding and bottle feeding women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kashish Chaudhary |
| Designation |
Post Graduate Physiotherapy Student |
| Affiliation |
Manav Rachna International Institute of Research ans Studies |
| Address |
Manav Rachna International Institute of Research and Studies Sector 43 Aravali Hills Surajkund Road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9810677377 |
| Fax |
|
| Email |
kc121098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kashish Chaudhary |
| Designation |
Post Graduate Physiotherapy Student |
| Affiliation |
Manav Rachna International Institute of Research ans Studies |
| Address |
Manav Rachna International Institute of Research and Studies Sector 43 Aravali Hills Surajkund Road Faridabad Haryana
HARYANA
121004
India |
| Phone |
9810677377 |
| Fax |
|
| Email |
kc121098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kashish Chaudhary |
| Designation |
Post Graduate Physiotherapy Student |
| Affiliation |
Manav Rachna International Institute of Research ans Studies |
| Address |
Manav Rachna International Institute of Research and Studies Sector 43 Aravali Hills Surajkund Road Faridabad Haryana
HARYANA
121004
India |
| Phone |
9810677377 |
| Fax |
|
| Email |
kc121098@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarvodaya Hospital Sector 8 Faridabad Haryana 121006 YMCA Road |
|
|
Primary Sponsor
|
| Name |
Kashish Chaudhary |
| Address |
Manav Rachna International Institute of Research and Studies Sector 43 Aravali Hills Surajkund Road Faridabad Haryana |
| 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 Zaheen Ahamad Iqubal |
Sarvodaya Hospital |
Pediatrics Department Sarvodaya Hospital, sector-8, Faridabad, Haryana, 121006
Faridabad
HARYANA |
8447393967
zaheeniqbal.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department ethical committee Department of physiotherapy School of allied health sciences Manav rachna international institute of research and studies Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lactating Postpartum Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Predominantly bottle feeding |
Myofascial trigger points cervical mobility lumbar flexibility psychological well being and sleep quality will be assessed using different tools and tests
It will take 30 minute on each participant |
| Intervention |
Predominantly breastfeeding |
Myofascial trigger points cervical mobility lumbar flexibility psychological well being and sleep quality will be assessed using different tools and tests
It will take 30 minute on each participant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women three to six months after delivery who is predominantly breastfeeding or predominantly bottle feeding or women fluent in English or women who were physically active or women able to give informed consent or willing to participate |
|
| ExclusionCriteria |
| Details |
History of neurological condition like stroke epilepsy or orthopedic condition like chronic low back pain or systemic condition like diabetes mellitus or psychiatrist illness like depression or currently pregnant women or inability to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of myofascial trigger point prevalence cervical range of motion lumbar flexibility psychological well being scores and sleep quality scores in breastfeeding and bottle feeding women |
3 to 6 months postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
09/03/2026 |
| 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="3"
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
|
The primary aim of this study is to compare the presence of myofascial trigger points cervical mobility and lumbar flexibility among predominantly breastfeeding and predominantly bottle feeding women along with how the psychological well being and sleep quality affects the two groups it is a comparative analytical cross sectional study targeting pastpartum women to assess and compare their musculoskeletal as well as mental health this study will assist in enhancing the treatment approach and corrective measures for the postpartum lactating women |