The Effect of Lactation Counseling on Breastfeeding Behaviors of Women

NCT ID: NCT05484076

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-29

Study Completion Date

2024-06-06

Brief Summary

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Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the article has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".

Detailed Description

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Breast milk is the main source of nutrition for newborns. Although breastfeeding is seen as a necessary process to meet the nutritional needs of babies in the early stages of life, it has a key role for a healthy generation in the long run. In this respect, the project has a unique value for a sustainable future in terms of its effects on the mother and baby in particular and on the social level in general. It is basically a human right that every baby has the potential for a healthy future by being fed with breast milk. In particular, the disruptions experienced in health services during the pandemic process have also significantly affected maternal and child health services. In this respect, another unique value is that it is a longitudinal study that includes innovative methods to be taken at the national level to quickly compensate for the lost momentum in breastfeeding during the pandemic process. Face-to-face counseling and training will start during pregnancy, and then continue as telehealth services. Continuity of counseling will increase the mother's compliance with breastfeeding. Behavior change, which will be developed individually, will also positively affect mother-infant harmony and family-spouse harmony, thus supporting the creation of a healthy development environment. Another unique value of the study is that it will provide data on the comparison of innovative education methods with traditional education methods. Thus the findings obtained will help to improve, regulate or build capacity of future initiatives.

The study was planned as a randomized controlled longitudinal study. The research is planned to be carried out between September 2022 and January 2023 in Çukurova University Medical Faculty Balcalı Training and Research Hospital pregnant outpatient clinic. The sample of the study will consist of 104 pregnant women, 52 of whom are in the experimental group and 52 in the control group, determined by power analysis. A training module will be created by taking expert opinions. The training module will consist of 5 sessions. Each session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer. Module sessions will have a dynamic structure that takes into account the needs of mother and baby during pregnancy and postpartum period. At 34-38 weeks of pregnancy, the first interviews are face-to-face at the hospital, the second interview is postpartum 1-5. day depending on the conditions, face-to-face or online, subsequent meetings will be held online. During the implementation phase, quantitative measurements of the research will be carried out by using the "Antenatal Pregnant Information Form", "Postnatal Mother Information Form", " The Infant Breastfeeding Assesment Tool", "Breastfeeding Motivation Scale", IOWA Infant Nutrition Attitude Scale" and " Mother-To-İnfant Bonding Scale".

the scope of the widespread effect of our research; The training booklet prepared with the expert opinion for the training process will be brought to the field.

Conditions

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Breastfeeding Mothers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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breastfeeding counseling

Pregnant women will be given breastfeeding counseling, which will take place in a total of five sessions at specified intervals.

Group Type EXPERIMENTAL

breastfeeding counseling

Intervention Type OTHER

A breastfeeding booklet will be created by the researchers by taking expert opinion. This booklet will explain everything about breastfeeding in five sessions.

At 34-38 weeks of pregnancy, the first interviews will be done face-to-face at the hospital. The second interview will be made face-to-face or online, depending on the conditions, in the first 1-5 days after the birth. Subsequent interviews (postpartum 1-4 weeks, postpartum 5-12 weeks, postpartum 13-24 weeks) will be held online. The scales used in the research will be applied twice, before and after the training.

control group

No training will be given to the control group. They will be asked to fill in the questionnaires included in our study at specified intervals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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breastfeeding counseling

A breastfeeding booklet will be created by the researchers by taking expert opinion. This booklet will explain everything about breastfeeding in five sessions.

At 34-38 weeks of pregnancy, the first interviews will be done face-to-face at the hospital. The second interview will be made face-to-face or online, depending on the conditions, in the first 1-5 days after the birth. Subsequent interviews (postpartum 1-4 weeks, postpartum 5-12 weeks, postpartum 13-24 weeks) will be held online. The scales used in the research will be applied twice, before and after the training.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being over 18 years old
* Not having received breastfeeding counseling before
* Being her first pregnancy
* Those who have a communication device that can use and download Teknolojik-Online systems (Smartphone, message, Google forms, zoom, whatsaap)
* Not having a vision-hearing problem
* Ability to read and write
* Last trimester (34 and above gestational weeks)
* Single pregnancy
* Giving birth at term (38-40 weeks)
* The newborn does not have health problems that require hospitalization

Exclusion Criteria

* Maternal (mastectomy, breast-milk infection and drug use, psychiatric diseases, etc.) preventing breastfeeding,
* Fetal (cleft palate, chromosomal anomalies, neurological diseases that may adversely affect breastfeeding, etc.)
* Unwillingness to continue research
* Having situations that require separation of mother and baby in the postpartum period
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziantep Islam Science and Technology University

OTHER

Sponsor Role lead

Responsible Party

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Tugce Sonmez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tuğçe sönmez, PhD

Role: PRINCIPAL_INVESTIGATOR

Tarsus University

Locations

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Tuğçe Sönmez

Toroslar, Mersin, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Sonmez T, Surucu SG, Vurgec BA. Effects of hybrid breastfeeding counseling on women's breastfeeding behaviors: a randomized controlled longitudinal study. BMC Pregnancy Childbirth. 2025 Jun 7;25(1):663. doi: 10.1186/s12884-025-07781-z.

Reference Type DERIVED
PMID: 40483454 (View on PubMed)

Other Identifiers

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200720asel

Identifier Type: -

Identifier Source: org_study_id

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