- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05562245
Motivational Interviewing-Based Breastfeeding Education
The Effect of Motivational Interviewing-Based Breastfeeding Education on Breastfeeding Motivation, Breastfeeding Success, and Breastfeeding Self-Efficacy Perceptions After Cesarean Section
The general purpose of this project is; to evaluate effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
The sub-aims of the study were to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding outcomes of primiparous mothers who gave birth by cesarean section.
The study will be conducted between September 2022- March 2023 at Konya a private hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was planned as a randomized controlled experimental study. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list.
A total of 80 primiparous mothers who gave birth by cesarean section, 40 in the experimental group and 40 in the control group, will be included in the study.
Pre-Test Information Collection Form at the 1st hour after Caesarean section, Postpartum 5-7. Day Follow-up Form, Postpartum 6th Week Follow-Up Form and Postpartum 3rd Month Follow-up Form, LATCH Breastfeeding Assessment Tool, Breastfeeding Self-Efficacy Short Form Scale, The Primipara Breastfeeding Motivation Scale, Confidence-sufficiency and importance a scale.
Breastfeeding education based on motivational interviewing will be held for mothers in the experimental group, 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. Routine breastfeeding training of the hospital will be given to mothers in the control group 1st hour after cesarean section and will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
The breastfeeding guide prepared by the researcher will be given to the mothers in the experimental and control groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey
- Medicana Konya Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer to participate in the study,
- Cesarean delivery,
- Does not have a condition that prevents breastfeeding,
- Married
- Primiparous,
- Not receiving general anesthesia,
- At least primary school graduate,
- 18 years and above,
- Do not have any chronic disease,
- The birth weight of the baby is 2500 g and above,
- Your baby's APGAR score is 7 and above in the 5th minute,
- Mothers whose babies do not have congenital and/or metabolic diseases will be included in the study.
Exclusion Criteria:
- Having multiple pregnancy and giving birth,
- Foreign nationals and do not speak Turkish,
- Having a history of preeclampsia, eclampsia and gestational diabetes,
- Mothers who develop complications during cesarean section and whose transfer to the service exceeds 1 hour (because breastfeeding will be delayed for the first hour),
- COVID-19 positive in the 1st hour after birth and having a condition that prevents breastfeeding,
- Those with a history of diagnosed mental or psychiatric illness will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
|
Motivational interviewing is basically a directive and client-centered psychosocial intervention used to help individuals discover and analyze ambivalent emotions related to their health behaviors, to learn new skills and to improve their existing skills. One of the main guiding principles in motivational interviewing is self-support and empowerment. The interviews consist of one to four sessions lasting between 7.5-60 minutes. A total of four motivational interviews will be held with the mothers in the experimental group. |
No Intervention: Control arm
1st hour after cesarean section will be made pre-tests and routine breastfeeding training of the hospital will be given to mothers in the control group.
Mothers will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LATCH Breastfeeding Assessment Tool
Time Frame: Change from LATCH Breastfeeding Assessment Tool at 3 months
|
The scale consists of five evaluation criteria and each item is evaluated between 0-2 points.
The score that can be obtained from the measurement tool can vary between 0-10.
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Change from LATCH Breastfeeding Assessment Tool at 3 months
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Breastfeeding Self-Efficacy Short Form Scale
Time Frame: Change from Breastfeeding Self-Efficacy Short Form Scale at 3 months
|
The scale consists of 33 items.
It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained
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Change from Breastfeeding Self-Efficacy Short Form Scale at 3 months
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The Primipara Breastfeeding Motivation Scale
Time Frame: Change from The Primipara Breastfeeding Motivation Scale at 3 months
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The Primipara Breastfeeding Motivation Scale: The scale consists of 29 items and is scored between 1-7.
It has a total of four sub-dimensions.
Evaluation is made by summing the scores obtained in each subgroup in the scale.
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Change from The Primipara Breastfeeding Motivation Scale at 3 months
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Confidence- sufficiency and importance a scale
Time Frame: Change from Confidence- sufficiency and importance a scale at 3 months
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It is a grading scale prepared in the form of a visual analog scale.
The score that can be obtained from the scale varies in the range of 0-10 points.
|
Change from Confidence- sufficiency and importance a scale at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of feeding the baby with only breast milk
Time Frame: 3 months
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1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month
|
3 months
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Total breastfeeding time
Time Frame: 3 months
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1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Halime Esra Meram, PhD, esrameran@selcuk.edu.tr
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
- 2022/28
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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