| CTRI Number |
CTRI/2023/03/050836 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Evaluation of Effectiveness of Video Intervention for awareness on postpartum depression] |
| Study Design |
Other |
|
Public Title of Study
|
Study on Awareness and Management based Health Action using Video Intervention for Postpartum Depression among mothers attending immunization clinic in a tertiary medical college hospital |
|
Scientific Title of Study
|
Study on Awareness and Management based
Health Action using video intervention
(SAMBHA V) for Postpartum depression among
mothers attending immunization clinic in a tertiary
medical college hospital |
| Trial Acronym |
SAMBHAV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Latha K |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9611732837 |
| Fax |
|
| Email |
latha12k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latha K |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9611732837 |
| Fax |
|
| Email |
latha12k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Latha K |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Department of Mental Health Education Ground Floor Dr M V Govindaswamy Block Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9611732837 |
| Fax |
|
| Email |
latha12k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ( ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Latha K |
Immunization Clinics, Field Practice Area Ramaiah Medical College Hospital |
M S Ramaiah Medical College and Hospital M S Ramaiah Nagar MSRIT Post Bangalore 560054
Bangalore
KARNATAKA |
9611732837
latha12k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neuro Sciences (NIMHANS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum Mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effectiveness of video intervention for awareness and management of postpartum depression |
A video of 10 min duration will be developed and showed to the participants. A pretest and a post test will be conducted along with feedback. Later this video will be used as one of means for health education. |
| Comparator Agent |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. All post-partum mothers less than 6 months after childbirth attending immunization clinic.
2. Post-partum women who are willing to give consent and is able to understand and speak in Kannada or English
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of video intervention intended to improve the awareness about Postpartum Depression among the mothers and help in early identification & effective management with better outcomes for the self-Care, prevent recurrence during subsequent pregnancy or child birth, and aids in child care & cognitive development |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The video intervention can be useful to be showed to all the expectant mothers and mothers attending immunization clinics for creating awareness on post-partum depression |
1 year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/11/2023 |
| 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="2"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study attempts to develop and assess the effectiveness of a video-based educational intervention to improve awareness on Postpartum Depression among mothers attending immunization clinics. The developed educational video series intends for early identification and intervention, selfcare and management, prevention of recurrence among mothers with PPD. It will also be useful to reduce the stigma and bridge the treatment gap. The final outcome of the study is aimed towards a better maternal mental health, improved help-seeking, child care and cognitive development. The developed video intervention can further be used as an educational tool to improve perinatal mental health literacy among expectant mothers, mothers, families and also for capacity building and training of health professionals and healthcare workers. |