- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660965
The Effect of Podcast Breastfeeding Training on Mothers of Preterm Infants
The Effect of Podcast Breastfeeding Training on Breastfeeding Outcomes of Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dilek Küçük Alemdar, Professor
- Phone Number: +905468435840
- Email: dilekkucukalemdar@gmail.com
Study Locations
-
-
Ordu
-
Merkez, Ordu, Turkey (Türkiye), 52200
- Recruiting
- Ordu University
-
Contact:
- Dilek Küçük Alemdar
- Email: dilekkucukalemdar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The mother must volunteer to participate in the study,
- The mother must be 18 years of age or older
- After being accepted into the study, the mother must express her intention to breastfeed her baby
- The mother must be able to speak and read Turkish
- The mother's baby being between 32 and 37 weeks gestation
Exclusion Criteria:
- Illegal drug and tobacco use by the mother
- The mother's use of alcohol during pregnancy and after childbirth
- Active tuberculosis in the mother
- The presence of Herpes simplex virus lesions on the mother's breast
- The presence of a maternal psychiatric disorder
- Having prior experience breastfeeding a preterm infant
- Having a condition that prevents breastfeeding
- Mothers who have had multiple births.
Study Plan
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: Podcast group
A podcast series on breastfeeding education will be shared with the mothers in the experimental group via a digital platform (WhatsApp).
The content will cover: breastfeeding preterm infants, why breast milk is important, the composition of breast milk and its importance for preterm infants, and the benefits of breast milk for preterm infants, the breastfeeding process at YYBÜ, conditions for expressing and storing milk, challenges encountered during breastfeeding and their solutions, ways to increase milk production, seeking support for breastfeeding at YYBÜ, the role of breast milk in the nutrition of preterm infants, and recommendations for breastfeeding.
Daily follow-up calls will be conducted to monitor whether the mothers are listening to the podcasts.
|
A podcast series on breastfeeding education will be shared with the mothers in the experimental group via a digital platform (WhatsApp).
The content will cover: breastfeeding preterm infants, why breast milk is important, the composition of breast milk and its importance for preterm infants, and the benefits of breast milk for preterm infants, the breastfeeding process at YYBÜ, conditions for expressing and storing milk, challenges encountered during breastfeeding and their solutions, ways to increase milk production, seeking support for breastfeeding at YYBÜ, the role of breast milk in the nutrition of preterm infants, and recommendations for breastfeeding.
Daily follow-up calls will be conducted to monitor whether the mothers are listening to the podcasts.
|
|
No Intervention: Control group
Mothers in the control group will receive only the standard breastfeeding education provided as part of the hospital protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Awareness Scale
Time Frame: One day after admission to the hospital. One day before discharge from the hospital.
|
This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period.
The scale is unidimensional and was developed using a 5-point Likert scale.
Responses to the scale items range from (1) Never to (5) Always.
The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.
|
One day after admission to the hospital. One day before discharge from the hospital.
|
|
Breastfeeding Motivation Scale (BMS)
Time Frame: One day after admission to the hospital. One day before discharge from the hospital.
|
The scale consists of 24 items and has 5 subscales.
There is no total score for the scale.
Subscale scores are calculated by taking the average of the subscale item scores.
As the score on a subscale increases, the motivation associated with that subscale also increases.
For multiparous mothers, the scale consists of 24 items and six factors, while for primiparous mothers, it consists of 23 items and five subfactors.
The 24-item scale can be used for both multiparous and primiparous mothers.
|
One day after admission to the hospital. One day before discharge from the hospital.
|
|
Breastfeeding Self-Efficacy Scale (Short Form)
Time Frame: One day after admission to the hospital. One day before discharge from the hospital.
|
The Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert-type scale, with responses rated as follows: 1 = "Not at all confident," 2 = "Not very confident," 3 = "Sometimes confident," 4 = "Confident," and 5 = "Very confident."
The minimum score on the scale is 14, and the maximum is 70.
A higher score indicates higher breastfeeding self-efficacy.
The short form of the scale is easy to administer and accurately assesses self-efficacy.
|
One day after admission to the hospital. One day before discharge from the hospital.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inadequate Breastfeeding Perception Scale
Time Frame: One day after admission to the hospital. One day before discharge from the hospital.
|
It is a measure used to assess breastfeeding mothers' perceptions of insufficient milk supply. The first question asks the mother about her belief regarding whether she is feeding her baby sufficiently. The mother answers this question with "yes" or "no." The other questions on the scale are designed to measure the perception of milk insufficiency. Mothers are asked to rate these questions on a scale of 0 to 10. A score of "0" indicates that the milk is perceived as completely insufficient, while a score of "10" indicates that the milk is perceived as completely sufficient. A minimum score of 0 and a maximum score of 50 can be obtained on the scale. A higher total score indicates an increased perception of milk sufficiency. |
One day after admission to the hospital. One day before discharge from the hospital.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAEK250
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
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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