Clinical trial NCT05484076: The Effect of Lactation Counseling on Breastfeeding Behaviors of Women
Official title: The Effect of Lactation Counseling on Breastfeeding Behaviors of Women: A Randomized Controlled Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Mothers
Keywords: baby
breastfeeding
counseling
mother
telehealth
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antenatal Pregnant Information Form
timeFrame: 34-38 weeks of pregnancy
measure: Postnatal Mother Information Form
timeFrame: postpartum 1-5 day
measure: The Infant Breastfeeding Assesment Tool
timeFrame: postpartum first 6 months
measure: Breastfeeding Motivation Scale
timeFrame: postpartum first 6 months
measure: Iowa Infant Nutrition Attitude Scale
timeFrame: postpartum first 6 months
measure: Mother-To-İnfant Bonding Scale
timeFrame: postpartum first 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toroslar
country: Turkey
facility: Tuğçe Sönmez
state: Mersin
Study officials:
affiliation: Tarsus University
name: tuğçe sönmez, PhD
role: PRINCIPAL_INVESTIGATOR
References: