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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05342831
Other study ID # KSUHATICEGULOZTAS001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2020
Est. completion date June 5, 2021

Study information

Verified date April 2022
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date June 5, 2021
Est. primary completion date February 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biological Nutrition Technique
Biological nutrition technique woman trying Biological feeding technique was applied after each breastfeeding. Breastfeeding self-efficacy and breastfeeding success were assessed at regular intervals.

Locations

Country Name City State
Turkey Kahramanmaras ISU Kahramanmaras K.Maras

Sponsors (1)

Lead Sponsor Collaborator
Hatice Gul OZTAS

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary First Measurement:LATCH Observation and evaluation of mothers' breastfeeding success is measured using the LATCH scale.The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.
L: (Latch on the brest)) A: (Audible Swallowing) T: (Type of Nipple) C: (Comfort of Breast/ Nipple) H: (Hold/ Position)
LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding.
Measurement at the second encounter (first 24 hours after birth) for each group.
Primary Second Measurement:Breastfeeding Self-Efficacy Scale Çeviri sonuçlari Breastfeeding Self-Efficacy Scale Breastfeeding self-efficacy levels and breastfeeding self-confidence of mothers are measured with the breastfeeding self-efficacy scale. The Breastfeeding Self-Efficacy Scale (short form) consists of 14 items that measure the mother's breastfeeding self-efficacy. The maximum score that can be obtained from the scale is 70, and the minimum score is 14. High scores from the scale indicate high breastfeeding self-efficacy. The scale is 5-point Likert type; 1 = Not at all sure, 2 = Not so sure, 3 = Sometimes I'm sure, 4 = I'm sure, 5 = I'm very sure. Measurement for each group at the third encounter (2th day after birth).
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