Clinical trial NCT05342831: Biological Nutrition Technique Which is Used in Initiation of Breastfeeding
Official title: The Effect of Biological Nutrition Technique Which is Used in Initiation of Breastfeeding in Primiparas on Breastfeeding Success and on Self-Efficacy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Self Efficacy
Keywords: Primiparous
Midwifery
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 130
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.

Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control).

Detailed description: Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.

Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control). The mothers in the control group received routine hospital care. The mothers in the experimental group were taught the biological nurturing technique after the first breastfeeding and breastfeeding was provided according to the technique during the hospitalization. Pre-test data were obtained by applying LATCH and BSES-SF to the mothers in the experimental and control groups at the 1st hour after the first breastfeeding. LATCH was re-administered at the end of the 8th and 24th hour postpartum. Post-test data were obtained by administering LATCH and BSES at the end of the 48th hour postpartum.In statistical analysis; count, percentage distribution, arithmetic average, chi-square test, standard deviation, t-test in dependent and independent groups and ANOVA analysis in repeated measurements were used.

Eligibility criteria: Inclusion Criteria:

* Being 18 years and older,
* Having a full-term, single and healthy newborn,
* Having no known health problems
* Having no general anesthesia
* Implementation of planned cesarean delivery,
* Primiparous women who do not have a condition that prevents breastfeeding. Inclusion criteria of the research for infants

Exclusion Criteria:

• Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)

Primary outcomes:
measure: First Measurement:LATCH
timeFrame: Measurement at the second encounter (first 24 hours after birth) for each group.
measure: Second Measurement:Breastfeeding Self-Efficacy Scale Çeviri sonuçları Breastfeeding Self-Efficacy Scale
timeFrame: Measurement for each group at the third encounter (2th day after birth).
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş ISU
state: K.Maraş
Study officials:
affiliation: KahramanmaraşISU
name: Hatice Gül Öztaş
role: PRINCIPAL_INVESTIGATOR
affiliation: İnönü University
name: Yeşim Aksoy Derya
role: STUDY_DIRECTOR
References:
citation: Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.