- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423534
Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
May 16, 2024 updated by: Mahmoud Khedr, Alexandria University
Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness.
Breastfeeding is how a mother and infant make their initial touch.
Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hail, Saudi Arabia
- Recruiting
- Faculty of Nursing, Hail university
-
Contact:
- Asmaa Ali
- Phone Number: 543132470
- Email: a.alabd@uoh.edu.sa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
- Primigravida mothers during last three trimester and 1 month after delivery
- No problems during pregnant and have a healthy baby
- Primigravida mothers who are not contraindicated to breastfeeding
Exclusion Criteria:
- Multigravida mothers and pregnant women during first and second trimester
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study GROUP
Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest).
During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy
|
Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.
Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
|
|
Active Comparator: Control group
The control group was selected first and received a brochure leaflet delivered by the researcher.
They didn't receive the health educational program
|
Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.
Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A preformatted structured questionnaire
Time Frame: 3 months
|
It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.
|
3 months
|
|
Self-Efficacy Scale - Short-Form (BSES-SF)
Time Frame: 3 months
|
It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study.
The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2024
Primary Completion (Estimated)
July 15, 2024
Study Completion (Estimated)
August 10, 2024
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 21, 2024
Study Record Updates
Last Update Posted (Actual)
May 21, 2024
Last Update Submitted That Met QC Criteria
May 16, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- H-2024-126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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