- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06362876
The Effect of Breastfeeding Counseling Based on Motivational Interviewing
The Effect of Breastfeeding Counseling Based on Motivational Interviewing Method in Women Having Cesarean Delivery
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey, 33180
- Mersin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between September 2023 and August 2024
- Living in Turkey
- Seeing the poster about the research on social media and applying for the research
- Those between the ages of 18-40,
- Native speaker of Turkish,
- 34-40 weeks of pregnancy. between weeks,
- First pregnancy,
- Having a singleton pregnancy,
- Determining the type of birth as planned cesarean section,
- Do not have any chronic disease or pregnancy complications,
- There is no obstacle to breastfeeding,
- Does not have any psychiatric disease,
- Not receiving any individual, special training or counseling other than standard training and counseling regarding breastfeeding during pregnancy,
- Women who are ambivalent about breastfeeding
Exclusion Criteria:
- Not attending at least one of the counseling sessions to be held,
- Under 34 weeks and over 40 weeks,
- Participating in another training or receiving counseling regarding breastfeeding,
- Those who have health problems during the education process,
- Mother or baby has a health problem that will affect breastfeeding processes in the postpartum period,
- Those who have situations that may interrupt breastfeeding (hospitalization, medication use, separation from the baby, etc.),
- Leaving messages unanswered during the research process, not answering phone calls at least 5 times a week, and not returning to the researcher,
- Women who developed a psychological condition or psychiatric disorder during the research process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Breastfeeding Counseling Based on Motivational Interviewing
Breastfeeding Counseling Based on Motivational Interviewing: An announcement was made on social media.
Women who were willing to participate in the research and met the inclusion criteria were informed about the research and an appointment was made with them and they were scheduled to log in.
All sessions were held with women individually and through online platforms.
Motivational Interview-Based Breastfeeding Training Hypnobreastfeeding training program consists of 6 sessions and 4 parts.
A total of 6 sessions were held with each woman, 3 implementation and 3 follow-ups.
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Breastfeeding Counseling Based on Motivational Interviewing Program The breastfeeding counseling based on motivational interviewing program consists of 6 sessions and 4 hours.
It includes information about breastfeeding, motivational preparation for the breastfeeding experience.
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Experimental: Standard Breastfeeding Consultancy
Standard Breastfeeding Consultancy: The standard breastfeeding counseling program was prepared by the researchers with reference to the Breastfeeding Counseling Handbook published by the Ministry of Health of the Republic of Turkey in 2015.
Training program consists of 6 sessions and 4 parts.
A total of 6 sessions were held with each woman, 3 implementation and 3 follow-ups.
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Standart Breastfeeding Consultancy The standard breastfeeding consultancy program consists of 6session and 4 hours.
It contains only information and applications about breastfeeding
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of breastfeeding self-efficacy
Time Frame: 34-40 weeks of pregnancy
|
Women's breastfeeding self-efficacy during pregnancy were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al.This scale consisting of 14 items is a 5 point Likert type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool. |
34-40 weeks of pregnancy
|
|
Level of breastfeeding self-efficacy
Time Frame: Postpartum 24-48 hours
|
Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. This scale consisting of 14 items is a 5 point Likert type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool. |
Postpartum 24-48 hours
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|
Level of breastfeeding self-efficacy
Time Frame: Postpartum 14. days
|
Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. This scale consisting of 14 items is a 5 point Likert type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool. |
Postpartum 14. days
|
|
Level of breastfeeding self-efficacy
Time Frame: Postpartum 1. month
|
Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. This scale consisting of 14 items is a 5 point Likert type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool. |
Postpartum 1. month
|
|
Level of breastfeeding self-efficacy
Time Frame: Postpartum 3. month
|
Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. This scale consisting of 14 items is a 5 point Likert type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool. |
Postpartum 3. month
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|
Breastfeeding Results Evaluation Form
Time Frame: Postpartum 24-48 hours
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The breastfeeding process evaluation form was created by researchers as a result of a literature review.
The breastfeeding results evaluation form consists of 13 questions.
It is a measurement tool that primarily determines individuals' current breastfeeding status, breastfeeding intentions in the first 6 months, breastfeeding confidence-sufficiency and breastfeeding importance scores.
Breastfeeding confidence-sufficiency and breastfeeding importance scores are in the range of 0-10, and it is accepted that the higher the score, the higher the importance and value given.
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Postpartum 24-48 hours
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Breastfeeding Results Evaluation Form
Time Frame: Postpartum 14. days
|
The breastfeeding process evaluation form was created by researchers as a result of a literature review.
The breastfeeding results evaluation form consists of 13 questions.
It is a measurement tool that primarily determines individuals' current breastfeeding status, breastfeeding intentions in the first 6 months, breastfeeding confidence-sufficiency and breastfeeding importance scores.
Breastfeeding confidence-sufficiency and breastfeeding importance scores are in the range of 0-10, and it is accepted that the higher the score, the higher the importance and value given.
|
Postpartum 14. days
|
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Breastfeeding Results Evaluation Form
Time Frame: Postpartum 1. month
|
The breastfeeding process evaluation form was created by researchers as a result of a literature review.
The breastfeeding results evaluation form consists of 13 questions.
It is a measurement tool that primarily determines individuals' current breastfeeding status, breastfeeding intentions in the first 6 months, breastfeeding confidence-sufficiency and breastfeeding importance scores.
Breastfeeding confidence-sufficiency and breastfeeding importance scores are in the range of 0-10, and it is accepted that the higher the score, the higher the importance and value given.
|
Postpartum 1. month
|
|
Breastfeeding Results Evaluation Form
Time Frame: Postpartum 3. month
|
The breastfeeding process evaluation form was created by researchers as a result of a literature review.
The breastfeeding results evaluation form consists of 13 questions.
It is a measurement tool that primarily determines individuals' current breastfeeding status, breastfeeding intentions in the first 6 months, breastfeeding confidence-sufficiency and breastfeeding importance scores.
Breastfeeding confidence-sufficiency and breastfeeding importance scores are in the range of 0-10, and it is accepted that the higher the score, the higher the importance and value given.
|
Postpartum 3. month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gozde Gokce Isbir, Professor, Mersin University
Publications and helpful links
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
- BAlis
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
product manufactured in and exported from the U.S.
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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