- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705932
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breastfeeding is recognized as the optimal method of infant feeding and provides substantial health benefits for both infants and mothers. The World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first six months, and continued breastfeeding with appropriate complementary feeding up to two years of age or beyond. Despite these recommendations, exclusive breastfeeding rates remain below desired levels worldwide.
Successful breastfeeding is influenced by multiple psychological, educational, and sociocultural factors. Primiparous mothers frequently experience uncertainty, anxiety, inadequate confidence, and misconceptions regarding breastfeeding. Breastfeeding myths, such as concerns about insufficient milk supply or beliefs that certain maternal characteristics determine breastfeeding success, may negatively affect breastfeeding practices and continuation. Maternal anxiety has also been associated with reduced breastfeeding confidence and motivation.
Advances in information and communication technologies have created new opportunities for delivering breastfeeding education. Video-assisted educational interventions provide standardized, visually supported, and repeatedly accessible learning materials that may improve knowledge acquisition, reinforce practical skills, and increase maternal confidence. However, evidence regarding the effectiveness of structured video-assisted breastfeeding education on breastfeeding motivation, breastfeeding myths, and maternal state anxiety among primiparous women remains limited.
This study is designed as a parallel-group randomized controlled trial conducted in Family Health Centers in Iğdır Province, Türkiye. Eligible primiparous pregnant women will be randomly allocated to either a video-assisted breastfeeding education group or a routine care group. The educational intervention consists of three expert-developed video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths. Videos will be delivered weekly via WhatsApp during late pregnancy. Participants may view the videos as often as desired, and researchers will obtain feedback after each module through telephone or WhatsApp communication.
Women allocated to the control group will receive routine breastfeeding education provided within standard antenatal and postnatal healthcare services. Outcome assessments will be conducted before the intervention during pregnancy and again at eight weeks postpartum. The study aims to determine whether video-assisted breastfeeding education can improve breastfeeding-related psychological and behavioral outcomes compared with routine care alone.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 years or older.
- Primiparous pregnant women.
- Gestational age between 32 and 36 weeks.
- Planning to breastfeed after delivery.
- Singleton pregnancy.
- Able to read and write in Turkish.
- Using WhatsApp.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- High-risk pregnancy or serious obstetric complications.
- Newborns with serious congenital anomalies or medical conditions requiring treatment and separation from the mother (e.g., dysphagia).
- Mothers with severe nipple abnormalities that may prevent breastfeeding.
- Withdrawal of informed consent at any stage of the study.
Study Plan
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: intervention arm
Participants assigned to the intervention group will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants may watch the videos as often as needed and will receive follow-up through telephone or WhatsApp after each module to address questions and obtain feedback.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
|
Participants will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules developed based on current evidence and expert opinion.
The modules cover breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants will be able to watch the videos repeatedly at their convenience.
After each module, researchers will contact participants via telephone or WhatsApp to obtain feedback and answer questions.
|
|
No Intervention: Control Arm
Participants assigned to the control group will receive routine antenatal and postnatal care, including standard breastfeeding education provided by healthcare professionals.
No additional video-assisted educational intervention will be provided.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Motivation
Time Frame: Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
|
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale to evaluate the effect of the video-assisted breastfeeding education program among primiparous women.
|
Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BilecikSeyhEU-KDH-GA-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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