- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369947
The Effect of Artificial-Intelligence-Assisted Videos on Breastfeeding Self-Efficacy, Motivation, and LATCH Scores in First-Time Mothers
January 28, 2026 updated by: Elif Dogan, Istanbul University - Cerrahpasa
The Effect of Watching Artificial-Intelligence-Assisted Breastfeeding Videos on Breastfeeding Self-Efficacy, Motivation, and LATCH Scores in First-Time Mothers: A Randomized Controlled Trial
As of 2024, nearly half (48%) of infants under six months worldwide are exclusively breastfed, approaching the global target of 50%.
Building on this progress, the World Health Organization has extended the target to 60% by 2030, emphasizing the need for innovative, scalable, and supportive interventions to strengthen breastfeeding practices.
Breastfeeding has well-established benefits for infant growth, immunity, and long-term health, while also reducing maternal postpartum complications and chronic disease risks.
Early postpartum support, particularly within the first hours after birth, is critical for successful and sustained breastfeeding.
However, in busy clinical settings, providing continuous and individualized support can be challenging, especially for primiparous women who may experience low confidence, pain, and insufficient guidance.
This randomized controlled trial aims to evaluate the effect of an artificial intelligence (AI)-supported relaxing breastfeeding video on breastfeeding self-efficacy, breastfeeding motivation, and LATCH scores among primiparous women.
Unlike instructional videos, the AI-based video is designed to promote emotional relaxation, instinctive breastfeeding perception, and maternal confidence during the early postpartum period.
The study adopts a two-arm randomized controlled experimental design.
The population consists of primiparous women who deliver vaginally at Ağrı Training and Research Hospital postpartum unit between February and June 2026.
A priori power analysis (α=0.05, power=0.95) indicated a minimum sample size of 38 participants; considering a 20% attrition rate, a total of 46 women (23 per group) will be recruited.
Eligible participants include primiparous, Turkish-speaking women without postpartum or neonatal complications.
Women who undergo cesarean delivery, have medical or psychiatric conditions preventing breastfeeding, or whose newborns require intensive care will be excluded.
Participants will be randomized into intervention and control groups using an online randomization tool.
All participants will receive a standardized 5-minute breastfeeding education based on the Turkish Ministry of Health breastfeeding counseling guidelines.
In addition to standard care, the intervention group will watch a 10-minute AI-supported relaxing video at the 2nd and 6th postpartum hours during breastfeeding.
The video will be displayed via tablet while the mother is in a comfortable breastfeeding position.
The control group will receive standard care only.
The AI-generated video will be produced using Kling AI, a generative video platform that enables controlled text-to-video workflows.
To ensure ethical and cultural sensitivity, the video will not include real human or animal breastfeeding images.
Instead, it will feature abstract, metaphorical visuals (e.g., pastel silhouettes, minimalist line art, or flat illustrations) that convey calmness, bonding, rhythm, and instinctive closeness.
The final version will be selected following expert review and pilot testing with three postpartum women.
Low-level white noise (<60 dB) will accompany the video to enhance maternal relaxation and infant comfort.
Data collection tools include a demographic information form, the Breastfeeding Self-Efficacy Scale-Short Form, the Primipara Breastfeeding Motivation Scale, and the LATCH Breastfeeding Assessment Tool.
Breastfeeding observations and LATCH scoring will be conducted by an independent midwife blinded to group allocation.
Statistical analyses will include descriptive statistics, paired and between-group comparisons, and repeated-measures analyses where appropriate.
Ethical approval will be obtained from the relevant institutional ethics committee, and written informed consent will be secured from all participants.
The findings are expected to contribute novel evidence on the role of AI-supported emotional and relaxing digital interventions in enhancing early postpartum breastfeeding outcomes and maternal confidence.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
46
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 Contact
- Name: Elif DOGAN
- Phone Number: +90 539 601 15 88
- Email: elifdogann18@gmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul University - Cerrahpasa
-
Contact:
- Elif DOGAN
- Phone Number: +90 539 601 15 88
- Email: elifdogann18@gmail.com
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Primiparous
- Single pregnancy
- Vaginal delivery
- No complications during the postpartum period
- No visual or auditory communication problems
- Women who speak and read Turkish.
Exclusion Criteria:
- Women who had a cesarean delivery
- Women with severe psychiatric conditions or impaired consciousness
- Women with conditions preventing breastfeeding (e.g., nipple problems, anatomical absence of the breast)
- Women requiring emergency surgical/medical intervention
- Presence of conditions preventing the newborn from breastfeeding (such as cleft palate/lip)
- Newborn admission to the NICU or presence of serious congenital anomalies
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental : AI-Assisted Breastfeeding Video Group
|
The intervention consists of an AI-supported relaxing breastfeeding video designed to enhance maternal calmness, confidence, and instinctive breastfeeding perception during the early postpartum period.
The video is generated using Kling AI through controlled text-to-video workflows.
To ensure ethical safety and cultural sensitivity, the content does not include real human or animal breastfeeding images.
Instead, it features abstract and metaphorical visuals (e.g., pastel silhouettes, minimalist line-art, or flat illustrations) symbolizing bonding, rhythm, and closeness.
The final version is selected following expert review and pilot testing.
The video lasts 10 minutes and includes low-level white noise (<60 dB) to support maternal relaxation and infant comfort.
Participants in the intervention group watch the video twice, at the 2nd and 6th postpartum hours, via tablet while breastfeeding in a comfortable position, in addition to standard breastfeeding care.
|
|
No Intervention: No Intervention : Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Effectiveness (LATCH Score)
Time Frame: 2 hours postpartum and 6 hours postpartum
|
Breastfeeding effectiveness will be evaluated using the LATCH Breastfeeding Assessment Tool, which assesses latch, audible swallowing, nipple type, maternal comfort, and positioning/hold.
Each domain is scored from 0 to 2, with total scores ranging from 0 to 10; higher scores indicate more effective breastfeeding.
|
2 hours postpartum and 6 hours postpartum
|
|
Breastfeeding Motivation
Time Frame: Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum
|
Breastfeeding motivation will be measured using the Primipara Breastfeeding Motivation Scale (PBMS), assessing maternal motivation across four domains: value of breastfeeding, self-efficacy, perceived midwife support, and success expectancy.
Higher scores indicate greater breastfeeding motivation.
The scale, consisting of 29 items and 29-203 points, is interpreted as indicating that women's motivation to breastfeed increases as their scores increase.
|
Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum
|
|
Breastfeeding Self-Efficacy
Time Frame: Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum
|
Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a validated 14-item Likert-type scale measuring maternal confidence in breastfeeding behaviors.
The lowest possible score on the scale is 14, and the highest possible score is 70.
A higher score indicates greater breastfeeding self-efficacy.
|
Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum
|
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 (Estimated)
February 15, 2026
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
July 15, 2026
Study Registration Dates
First Submitted
January 18, 2026
First Submitted That Met QC Criteria
January 18, 2026
First Posted (Actual)
January 27, 2026
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/559
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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