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BreastfeedingNCT07369947

The Effect of Artificial-Intelligence-Assisted Videos on Breastfeeding Self-Efficacy, Motivation, and LATCH Scores in First-Time Mothers

A study testing AI-Assisted Breastfeeding Video in people with Breastfeeding and Artificial Intelligence (AI), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
AI-Assisted Breastfeeding Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2026to 27 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Primiparous
  • Single pregnancy
  • Vaginal delivery
  • No complications during the postpartum period
  • No visual or auditory communication problems
  • Women who speak and read Turkish.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University - Cerrahpasa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
AI-Assisted Breastfeeding Video
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Assisted Breastfeeding VideoProcedure or surgery

    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.

Study groups in NCT07369947
Study groupRoleWhat they receive
Experimental : AI-Assisted Breastfeeding Video GroupExperimentalNot described
Receives: Procedure: AI-Assisted Breastfeeding Video
No Intervention : Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breastfeeding Motivation

    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.

    Measured: Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum

  2. Breastfeeding Self-Efficacy

    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.

    Measured: Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum

  3. Breastfeeding Effectiveness (LATCH Score)

    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.

    Measured: 2 hours postpartum and 6 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start15 Feb 2026
  3. Primary completion27 Jun 2026
  4. Study completion27 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07369947
Sponsor's protocol ID
2025/559
Status last verified
Jan 2026
First submitted
18 Jan 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-Assisted Breastfeeding Video in people with Breastfeeding and Artificial Intelligence (AI), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Motivation (time frame: Baseline (prior to intervention), 2 hours postpartum, and 6 hours postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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