- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355674
Adolescent Mother and Breastfeeding Education
Effect of Breastfeeding Education Given to Adolescent Mothers With Lactation Simulation Model on Maternal Breastfeeding Self-Efficacy, Maternal Infant Attachment, and Infant Anthropometric Measurements
In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.
In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sanliurfa, Turkey (Türkiye)
- Harran University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Giving birth vaginally between the 37th and 40th gestational weeks,
- Being under 18 years of age,
- Primigravida,
- Not having any systemic/chronic diseases,
- Willing to breastfeed,
- Having received breastfeeding counseling provided by the hospital,
- Being able to speak Turkish, and
- Adolescent mothers in the postnatal 1st and 2nd weeks will be included in the study.
Exclusion Criteria:
- Mothers giving birth before the 37th gestational week or after the 40th gestational week,
- Those with barriers hindering effective communication,
- Those unable to speak Turkish,
- Mothers who have not received breastfeeding counseling from the hospital,
- Non-breastfeeding mothers,
- Those experiencing interruptions in breastfeeding due to seasonal work or any other reason,
- Those supplementing breastfeeding with formula,
- Adolescent mothers who discontinue breastfeeding education provided through LSM will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breastfeeding education group
Adolescent mothers included in the breastfeeding education group will receive practical breastfeeding training using the lactation simulation model and newborn baby mannequin for 1.5-2 hours conducted by the researchers. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. |
The Lactation Simulation Model (LSM) is a high-fidelity simulator designed for interactive education, which educators can utilize for practical and wearable breastfeeding training.
It is wearable like a shirt and is secured onto the chest by passing it over the shoulders and fastening it with a safety belt from the back.
This allows the safety belt to be adjusted according to different body types and weights.
|
|
No Intervention: Control group
Adolescent mothers in the control group will continue with routine breastfeeding and follow-up at the family health center. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postnatal Breastfeeding Self-Efficacy Scale-Short Form
Time Frame: 4 months
|
The short form of the scale consists of a total of 14 items and is a 5-point Likert scale.
Scores on the scale can range from 14 to 70 points.
A higher score indicates higher maternal breastfeeding self-efficacy.
|
4 months
|
|
Maternal-Infant Attachment Scale
Time Frame: 4 months
|
The scale consists of a total of eight items rated on a four-point Likert scale.
An increase in scores on the scale indicates an improvement in mother-infant attachment.
|
4 months
|
Collaborators and Investigators
Sponsor
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
- HRÜ/23.21.12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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