Clinical trial NCT05593536: Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status
Official title: Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: biological nurturing
breastfeeding
education
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status.

Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital between October 2022 and August 2023. F test at 90% effect power 0.25 medium effect level on the sample of the study analyzed using the Gpower (3.1.9.2) Programe. As a result of the analyze, it was planned to recruit 207 nulliparous pregnant women. According to the calculation made, there should be at least 69 people in each groups. Accordingly, 69 people in the experimental 1 group (biological nurturing), 69 people in the experimental 2 group (classical breastfeeding), 69 people should be included in the control group. Experimental 1 group and experimental 2 group will be given breastfeeding training on their first visit and after two weeks. Breastfeeding success in the postpartum period will be compared in all groups.


Eligibility criteria: Inclusion Criteria:

GROUP 1:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34- 36
* Those who are literate
* Those who have a smart phone and have the opportunity to benefit from teaching methods

GROUP 2:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34-36
* Those who are literate

GROUP 3:

* 18-35 age range
* Nulliparous Pregnancy
* Single Pregnancy
* Gestational week 34-36 gw
* Those who are literate

Exclusion Criteria:

GROUP1:

* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems

GROUP 2:

* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems

GROUP 3:

* Pregnant women who go to pregnancy school
* Presence of chronic disease
* Nipple problems
* Admission of the baby to the neonatal intensive care unit
* The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
* Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
* The presence of a disease in the mother that will prevent breastfeeding
* Pregnant women with vision and hearing problems

Primary outcomes:
measure: Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
timeFrame: Two weeks after the first training
measure: Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group
timeFrame: The first 24 hours of the postpartum period
measure: Higher ''LATCH Scale'' score in the biological nurturing group
timeFrame: The first 24 hours of the postpartum period
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
References:
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