- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487337
BREASTFEEDING SELF-EFFICACY AND MATERNAL ATTACHMENT IN WOMEN WITH PERCEIVED INSUFFICIENT MILK
THE EFFECT OF AN ANIMATION FILM ON BREASTFEEDING SELF-EFFICACY AND MATERNAL ATTACHMENT LEVELS OF WOMEN WITH PERCEIVED INSUFFICIENT MILK: A RANDOMIZED CONTROLLED TRIAL
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gazi̇osmanpaşa
-
Istanbul, Gazi̇osmanpaşa, Turkey (Türkiye), 34065
- Gaziosmanpaşa Training and Research Hospital Physical Therapy Additional Service Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Women without communication problems Pregnant women at 37 weeks of gestation or later attending the pregnancy school Healthy women aged between 18 and 49 years Women with a score of 25 or higher on the Perceived Insufficient Milk Scale Women without chronic diseases (such as cardiovascular diseases, Diabetes Mellitus, hypertension, etc.) Women without psychiatric disorders (such as major depression, psychosis, etc.)
Exclusion Criteria:
Women who experienced a high-risk pregnancy or labor process Women with a history of abortion or curettage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animation Film Group Routine Care Group
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
|
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
|
|
No Intervention: Kontrol Grubu
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy
Time Frame: Baseline, first week, and first month.
|
Breastfeeding self-efficacy levels were evaluated using the Breastfeeding Self-Efficacy Scale.
|
Baseline, first week, and first month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Attachment
Time Frame: Baseline, first week, and first month.
|
Maternal attachment levels were evaluated using the Postpartum Bonding Scale.
|
Baseline, first week, and first month.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ESMA KESKİN, BSc, MSc Student, Istinye University, Department of Midwifery, Istanbul, Turkey
- Study Director: REFİKA GENÇ KOYUCU, PhD, Istinye University, Department of Midwifery, Istanbul, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 24-321
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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