| CTRI Number |
CTRI/2025/01/079049 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [New Parent Support group ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial evaluating the effect of new parent support group on development of postpartum depression (PPD) and on level of postpartum bonding in mothers |
|
Scientific Title of Study
|
A randomized control trial evaluating the effect of new parent support group on development of postpartum depression (PPD) and on level of postpartum bonding in mothers of selected hospitals of central Gujarat |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jalpa Prajapati |
| Designation |
PhD Scholar |
| Affiliation |
Manikaka Topawala Institute of Nursing, Charotar University of Science and Technology |
| Address |
Room No-117
Department of Obstetrics & Gynecological Nursing,
Manikaka Topawala Institute of Nursing,Charusat University Changa, Anand GUJARAT India
Anand
GUJARAT
388421
India |
| Phone |
9586936357 |
| Fax |
|
| Email |
jalpaprajapati.nur@charusat.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Tiwari |
| Designation |
Associate Professor & HOD Obstetrics and Gynecological Nursing |
| Affiliation |
Manikaka Topawala Institute of Nursing, Charotar University of Science and Technology |
| Address |
Room no 109, Head of Department - Obstetrics & Gynecological Nursing department, Manikaka Topawala Institute of Nursing
Charusat University Changa Anand GUJARAT India
Anand
GUJARAT
388421
India |
| Phone |
8141060265 |
| Fax |
|
| Email |
anjalitiwari.nur@charusat.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Jalpa Prajapati |
| Designation |
PhD Scholar |
| Affiliation |
Manikaka Topawala Institute of Nursing, Charotar University of Science and Technology |
| Address |
Room No-117 Department of Obstetrics & Gynecological Nursing, Manikaka Topawala Institute of Nursing
Charusat University Changa, Anand GUJARAT
Anand
GUJARAT
388421
India |
| Phone |
9586936357 |
| Fax |
|
| Email |
jalpaprajapati.nur@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| Chaturbhai Gangadas General Hospital,SH 61, Uttarsanda, Gujarat 387370 India
|
| CHRF Hospital, CHARUSAT CAPUS, PETLAD, Changa, Anand, Gujarat 388421 India
|
| Dr. N.D. Desai Hospital,College Rd, Nalanda Nagar, Chalali, Nadiad, Gujarat 387003, India |
| Himalaya Hospital, Opp. Spring wood flats, Anand - Lambhvel road, B/h Zydus Hospital, Anand, Gujarat 388001 India
|
| Shraddha Hospital, Singalav Road, Borsad, Gujarat 388540 India
|
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| Type of Sponsor |
Other [Nill] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nipa Modi |
Aum Hospital & ICU |
Vendor char rasta, nr. Pioneer highschool, Patel Colony, Anand, Gujarat 388001
Anand
GUJARAT |
9426406834
drnipamodi@gmail.com |
| Dr Anilbhai K Gajjar |
Chaturbhai Gangadas General Hospital |
Obstetrics & Gynaec OPD, SH 61, Uttarsanda
Anand
GUJARAT |
9825650106
dr_anilgajjar@yahoo.co.in |
| Mr Dilip Patel |
CHRF Hospital |
Roon no 3 HR Department, Ground floor
Anand
GUJARAT |
02697265502
chrf@charusat.ac.in |
| Dr Arun H Vyas |
Dr. N.D. Desai Hospital |
College Rd, Nalanda Nagar, Chalali, Nadiad, Gujarat 387003
Kheda
GUJARAT |
9979405150
dean.medical@ddu.ac.in |
| Dr Sanjay Brahmbhatt |
Himalaya Hospital |
Opp. Spring wood flats, Anand - Lambhvel road, B/h Zydus Hospital, Anand, Gujarat 388001
Anand
GUJARAT |
7573998100
cashlesshimalaya@gmail.com |
| Dr Jay Soni |
Shraddha Hospital |
Sy No 1518,Singalav Road, Borsad, Gujarat 388540
Anand
GUJARAT |
9904472012
hr.shraddhaborsad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| AUM Hospital & ICU |
No Objection Certificate |
| Chaturbhai Gangadas General Hospital |
No Objection Certificate |
| CHRF,CHARUSATHospital |
No Objection Certificate |
| Dr. N D Desai Hospital |
No Objection Certificate |
| Himalaya Hospital |
No Objection Certificate |
| Institutional ethics committee CHARUSAT (IEC-CHARUSAT) |
Approved |
| Institutional ethics committee CHARUSAT (IEC-CHARUSAT) |
Approved |
| Shraddha Hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Arm |
Participants in this arm will not received New Parent Supportgroup intervention |
| Intervention |
New Parent Support Group |
In three week (21 Days) duration, first day of each week investigator will meet participants in person for 60 min duration.
Remaining 6 days of week, intervention will be continuing through whats app group
On Day 1 Introduction of researcher & Group members and Motivating mothers to share their child birth experience
Each week focuses on a specific educational topic:
During Week 1: Postpartum mental health awareness.
During Week 2: Positive mental health and self-care.
During Week 3: Positive parenthood and balancing personal life with self-care.
Mothers are guided through demonstrations of specific breathing exercises (Pranayama), including:
Anulom Vilom: 10 cycles per side.
Omkar: 10 counts for two cycles.
and Bhramari: 10 counts for two cycles.
Participants are also introduced to the Happy Moment Activity Log, which is a tool designed to help mothers document moments of happiness throughout the week
Day 2
Educational materials are shared covers a different topic week wise:
For Week 1: Breastfeeding education.
For Week 2: Kangaroo Mother Care (KMC) and thermoregulation.
For Week 3: Postpartum dietary guidance.
Mothers receive reminders about practicing Pranayama and completing their Happy Moment Activity Log.
Day 3
Motivational quotes about motherhood are shared in the WhatsApp group Mothers are encouraged to engage in specific activities:
Week 1: Share a selfie with their baby.
Week 2: Share a recipe for one of their favorite dishes.
Week 3: Share a voice note of a conversation with their baby.
Day 4
The WhatsApp group continues as the medium for sharing educational materials, focusing on the following themes:
Week 1: Myths and misconceptions about newborn care.
Week 2: Immunization.
Week 3: Family planning and healthcare.
Participants are reminded to maintain their Pranayama practice and update their Happy Moment Activity Log.
Day 5
Sharing of Motivational quotes. Mothers are encouraged to reflect on their interests & share:
Week 1: A daily activity they enjoy, such as walking, listening to music, or visiting a temple.
Week 2: A photo of themselves enjoying the morning sunshine.
Week 3: Their aspirations for the career their child might pursue in the future.
Day 6
Educational materials continue to be disseminated on:
Week 1: Managing minor postpartum ailments.
Week 2: Postnatal exercises.
Week 3: Lifestyle and recreational habits for overall well-being.
Reminders about Pranayama and the Happy Moment Activity Log are reiterated to reinforce consistency.
Day 7
The final day of each week includes motivational quotes & Mothers are encouraged to share:
Week 1: A family photo with the baby.
Week 2: A favourite or happy moment from their pregnancy.
Week 3: A voice note of themselves talking to their baby.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
-Have a singleton delivery within past 7 days through either normal or assisted vaginal delivery
-Are having postpartum blue as measured by EPDS score between 6-9.
-Are willing to participate in the study.
-Have access to their own smart phones device.
|
|
| ExclusionCriteria |
| Details |
- Who are clinically diagnosed with any psychological disorders
-Who are under any treatment involving use of antipsychotic drugs.
-Who have undergone operative delivery within past 7 days
-Who have had a still birth within past 7 days
-Who have had delivered baby with any malformation/deformity / disorder within past 7 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant change in levels of development of post partum depression & in levels of post partum bonding among postnatal mothers. |
21 Days Intervention duration |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| Date of Study Completion (India) |
27/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A randomized control trial will be conducted on evaluating the effect of new parent support group on development of postpartum depression (PPD) and on level of postpartum bonding in mothers of selected hospitals of central Gujarat. Post partum blue is the most common complication postpartum affecting majority women. If blue symptoms lasts for longer duration turns into postpartum depression which contributing greatly to maternal mortality and morbidity, but the care availed is very low among the women who suffer from post partum depression. New Parent suport group is intervention cycle for 21 days duration will have significant impact over development of post partum depression and level of postpartum bonding .
|