Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal AttachmentNCT07487337
BREASTFEEDING SELF-EFFICACY AND MATERNAL ATTACHMENT IN WOMEN WITH PERCEIVED INSUFFICIENT MILK
A study testing Animation Film Intervention in people with Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal Attachment, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of an animation film on breastfeeding self-efficacy and maternal attachment levels in women with perceived insufficient milk. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal Attachment
- What is being tested?
- Animation Film Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2025to 23 Aug 2025
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Women who experienced a high-risk pregnancy or labor process Women with a history of abortion or curettage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital Physical Therapy Additional Service Building
Istanbul, Gazi̇osmanpaşa, 34065
About this study
Official title: THE EFFECT OF AN ANIMATION FILM ON BREASTFEEDING SELF-EFFICACY AND MATERNAL ATTACHMENT LEVELS OF WOMEN WITH PERCEIVED INSUFFICIENT MILK: A RANDOMIZED CONTROLLED TRIAL
This randomized controlled study aims to evaluate the effect of an animation film on breastfeeding self-efficacy and maternal attachment levels in women with perceived insufficient milk. Women who perceive their breast milk as insufficient often experience decreased breastfeeding confidence and difficulties in mother-infant bonding. The animation film developed within the scope of the study provides information and supportive guidance about breastfeeding. The findings of this study are expected to contribute to improving breastfeeding self-efficacy and strengthening maternal attachment.
- Being tested
- Animation Film Intervention
- Keywords
- Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal Attachment, Breastfeeding Education, Animation-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation Film InterventionBehavioural
Women who had a score of 25 or higher on the Perceived Insufficient Milk Scale were included in the study and randomly assigned to the intervention group. Baseline assessments were conducted using the Woman Information Form, Breastfeeding Self-Efficacy Scale, and Postpartum Bonding Scale before the intervention. Participants then watched an animation film developed to address perceived insufficient milk. Follow-up assessments using the same scales were conducted at the first week and at the first month
| Study group | Role | What they receive |
|---|---|---|
| Animation Film Group Routine Care Group | Experimental | Women who had a score of 25 or higher on the Perceived Insufficient Milk Scale were included in the study and randomly assigned to the intervention group. Baseline assessments were conducted using the Woman Information Form, Breastfeeding Self-Efficacy Scale, and Postpartum Bonding Scale before the intervention. Participants then watched an animation film developed to address perceived insufficient milk. Follow-up assessments using the same scales were conducted at the first week and at the first month Receives: Behavioral: Animation Film Intervention |
| Kontrol Grubu | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
Breastfeeding self-efficacy levels were evaluated using the Breastfeeding Self-Efficacy Scale.
Measured: Baseline, first week, and first month.
Secondary outcomes (1)
Maternal Attachment
Maternal attachment levels were evaluated using the Postpartum Bonding Scale.
Measured: Baseline, first week, and first month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start23 May 2025
- Primary completion23 Aug 2025
- Study completion23 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal AttachmentStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the intervention group or the control group. Women in the intervention group watched an animation film developed to support breastfeeding, while the control group received routine care. Breastfeeding self-efficacy and maternal attachment levels were evaluated in both groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ESMA KESKİN, BSc, MSc Student, Study chair, Istinye University, Department of Midwifery, Istanbul, TurkeyREFİKA GENÇ KOYUCU, PhD, Study director, Istinye University, Department of Midwifery, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487337
- Sponsor's protocol ID
- 24-321
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF AN ANIMATION FILM ON BREASTFEEDING SELF-EFFICACY AND MATERNAL ATTACHMENT LEVELS OF WOMEN WITH PERCEIVED INSUFFICIENT MILK: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07487337
- Acronym / sponsor ID
- 24-321
- Keywords
- Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal Attachment, Breastfeeding Education, Animation-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 23 Aug 2025 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled study aims to evaluate the effect of an animation film on breastfeeding self-efficacy and maternal attachment levels in women with perceived insufficient milk. Women who perceive their breast milk as insufficient often experience decreased breastfeeding confidence and difficulties in mother-infant bonding. The animation film developed within the scope of the study provides information and supportive guidance about breastfeeding. The findings of this study are expected to contribute to improving breastfeeding self-efficacy and strengthening maternal attachment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the intervention group or the control group. Women in the intervention group watched an animation film developed to support breastfeeding, while the control group received routine care. Breastfeeding self-efficacy and maternal attachment levels were evaluated in both groups.
| Arm | Type | Receives |
|---|---|---|
| Animation Film Group Routine Care Group | Experimental | Behavioral: Animation Film InterventionWomen who had a score of 25 or higher on the Perceived Insufficient Milk Scale were included in the study and randomly assigned to the intervention group. Baseline assessments were conducted using the Woman Information Form, Breastfeeding Self-Efficacy Scale, and Postpartum Bonding Scale before the intervention. Participants then watched an animation film developed to address perceived insufficient milk. Follow-up assessments using the same scales were conducted at the first week and at the first month |
| Kontrol Grubu | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Women who experienced a high-risk pregnancy or labor process Women with a history of abortion or curettage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation Film InterventionWomen who had a score of 25 or higher on the Perceived Insufficient Milk Scale were included in the study and randomly assigned to the intervention group. Baseline assessments were conducted using the Woman Information Form, Breastfeeding Self-Efficacy Scale, and Postpartum Bonding Scale before the intervention. Participants then watched an animation film developed to address perceived insufficient milk. Follow-up assessments using the same scales were conducted at the first week and at the first month | Behavioural | Animation Film Group Routine Care Group |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: Baseline, first week, and first month.
Breastfeeding self-efficacy levels were evaluated using the Breastfeeding Self-Efficacy Scale.
1 secondary outcome
Maternal Attachment
Time frame: Baseline, first week, and first month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESMA KESKİN, BSc, MSc Student study chair
Istinye University, Department of Midwifery, Istanbul, Turkey
REFİKA GENÇ KOYUCU, PhD study director
Istinye University, Department of Midwifery, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation Film Intervention in people with Perceived Insufficient Milk, Breastfeeding Self-Efficacy, Maternal Attachment, run by Istinye University 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 0 inclusion and 1 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 23 Mar 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 Self-Efficacy (time frame: Baseline, first week, and first month.). 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 23 Mar 2026.