| CTRI Number |
CTRI/2024/11/076434 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercises for post partum depression |
|
Scientific Title of Study
|
The effect of mindfulness training Versus moderate aerobic training in improving postpartum blues among primiparous mothers – An experimental study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nageswari |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room No 315, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishika Masih |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E 004, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
easwar8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nageswari |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room No 315, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias university, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nageswari |
Galgotias university |
E 004, E block, Ground floor, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Gautam Buddha Nagar
UTTAR PRADESH |
9843073406
nagesmpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post natal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mindfulness training |
8 weeks |
| Comparator Agent |
moderate aerobic training |
8 weeks |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous mothers only as they shows many changes after their first delivery like depression and anxiety |
|
| ExclusionCriteria |
| Details |
Multiparous mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the depression level |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving the quality of life |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/11/2024 |
| 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="0"
Months="0"
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
|
Postpartum
blues or depression (PPD) is a significant mental health issue affecting many
new mothers, particularly primiparous mothers who are experiencing childbirth
for the first time. The condition can lead to severe emotional distress,
impacting both the mother and her ability to care for her newborn. Traditional
treatments for PPD often include pharmacotherapy and psychotherapy, but there
is growing interest in alternative and complementary approaches, such as
mindfulness training and moderate aerobic exercise |