| CTRI Number |
CTRI/2026/03/105410 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [multimodal educational intervention on breastfeeding self-efficacy and body image perception. ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of a nurse-led educational program on body image and breastfeeding confidence among first-time pregnant mothers. |
|
Scientific Title of Study
|
Effect of nurse led multimodal educational intervention protocol on maternal body image perception and breastfeeding self efficacy among primigravida mothers in IMS & SUM hospital Bhubaneswar. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ref. no/IEC/IMS.SH/SOA/2026/1268 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arnashree das |
| Designation |
M.Sc. nursing |
| Affiliation |
Sum nursing college |
| Address |
SUM Nursing College (Department of Obstetrics & Gynaecological Nursing)
Institute of Medical Sciences & SUM Hospital
Siksha ‘O’ Anusandhan (Deemed to be University)
K-8, Kalinga Nagar, PO: Ghatikia
Bhubaneswar, Odisha – 751003
India
Khordha
ORISSA
751003
India |
| Phone |
8101763368 |
| Fax |
|
| Email |
arnashreedas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Pratibha Khosla |
| Designation |
Associate professor |
| Affiliation |
Sum nursing college |
| Address |
SUM Nursing College (Department of Obstetrics & Gynaecological Nursing)
Institute of Medical Sciences & SUM Hospital
Siksha ‘O’ Anusandhan (Deemed to be University)
K-8, Kalinga Nagar, PO: Ghatikia
Bhubaneswar, Odisha – 751003
India
Khordha
ORISSA
751003
India |
| Phone |
9337555461 |
| Fax |
|
| Email |
pratibhakhosla@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arnashree das |
| Designation |
M.Sc. nursing |
| Affiliation |
Sum nursing college |
| Address |
SUM Nursing College (Department of Obstetrics & Gynaecological Nursing)
Institute of Medical Sciences & SUM Hospital
Siksha ‘O’ Anusandhan (Deemed to be University)
K-8, Kalinga Nagar, PO: Ghatikia
Bhubaneswar, Odisha – 751003
India
Khordha
ORISSA
751003
India |
| Phone |
8101763368 |
| Fax |
|
| Email |
arnashreedas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Arnashree Das |
| Address |
SUM Nursing College (Department of Obstetrics & Gynaecological Nursing)
Institute of Medical Sciences & SUM Hospital
Siksha ‘O’ Anusandhan (Deemed to be University)
K-8, Kalinga Nagar, PO: Ghatikia
Bhubaneswar, Odisha – 751003
India. |
| 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 |
| Arnashree Das |
IMS & SUM Hospital |
Department of Obstetrics and Gynaecology, Antenatal OPD, IMS & SUM Hospital, K8 Kalinganagar, Bhubaneswar, Odisha – 751003
Khordha
ORISSA |
8101763368
arnashreedas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnancy related condition antenatal period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led multimodal educational intervention on breast feeding self efficacy & body image perception. |
Experimental Group:
Participants will receive a nurse-led multimodal educational intervention protocol consisting of three structured sessions delivered during the third trimester of pregnancy (approximately 28–40 weeks gestation). Each session will last about 15–30 minutes and will include interactive lectures, group discussion, demonstration with visual aids, guided visualization, and relaxation exercises aimed at improving maternal body image perception and breastfeeding self-efficacy. The total duration of the intervention will be approximately 3 weeks (one session per week).
Control Group:
Participants will receive routine antenatal care as per hospital protocol without the structured multimodal educational intervention. |
| Comparator Agent |
routine antenatal care |
Participants in the control group will receive routine antenatal care as per hospital protocol, including standard health education on nutrition, personal hygiene, danger signs of pregnancy, and general breastfeeding advice provided during regular antenatal visits. No structured multimodal educational intervention will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primigravida mothers in third trimester (28-40/42 Weeks) of pregnancy.
2.Primigravida Mothers attending antenatal clinics in IMS & SUM hospital at Bhubaneswar.
3.Primigravida Mothers who are willing to participate and give the wriiten consent.
4.Primigravida Mothers who are able to read, write, or understand Odia/Hindi/English.
Yes, the participation is voluntary. |
|
| ExclusionCriteria |
| Details |
1.Primigravida mothers with high-risk pregnancies or medical complications.
2. Primigravida Mothers with known psychiatric illnesses or on psychiatric medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Breastfeeding self-efficacy score measured using the Breastfeeding Self-Efficacy Scale–Short Form (BSES-SF) .Maternal body image perception score measured using standardized body image scale |
Breastfeeding self-efficacy will be measured after 6 weeks of postpatum period. body image perception will be measured immediately after 2nd session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
02/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomized controlled trial aims to evaluate the effectiveness of a nurse-led multimodal educational intervention protocol on maternal body image perception and breastfeeding self-efficacy among primigravida mothers at IMS & SUM Hospital, Bhubaneswar. Pregnancy and the postpartum period are associated with significant physical and psychological changes that may influence maternal body image and confidence in breastfeeding. Improving breastfeeding self-efficacy during pregnancy may enhance successful breastfeeding practices in the postpartum period. Eligible primigravida mothers in the antenatal period will be randomly allocated into intervention and control groups using the lottery method. The intervention group will receive a structured nurse-led multimodal educational program during pregnancy, while the control group will receive routine antenatal health education. Baseline assessment will be conducted during the antenatal period prior to the intervention. Follow-up assessment will be conducted at 6 weeks postpartum. The primary outcome will be breastfeeding self-efficacy measured using a standardized scale. Secondary outcomes include maternal body image perception, change in pre- and post-intervention scores, and correlation between maternal body image perception and breastfeeding self-efficacy. The study aims to generate evidence on the effectiveness of structured nursing interventions in improving maternal psychological well-being and breastfeeding confidence. |