NCT05342831

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 4, 2022

Last Update Submit

April 20, 2022

Conditions

Keywords

PrimiparousMidwifery

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Second Measurement:Breastfeeding Self-Efficacy Scale Çeviri sonuçları 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).

Study Arms (2)

Experimental: experimental group

EXPERIMENTAL

Biological Nutrition Technique

Other: Biological Nutrition Technique

Assigned Interventions

NO INTERVENTION

standard care group

Interventions

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

Experimental: experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş ISU

Kahramanmaraş, K.Maraş, 46100, Turkey (Türkiye)

Location

Related 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 early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Hatice Gül Öztaş

    KahramanmaraşISU

    PRINCIPAL INVESTIGATOR
  • Yeşim Aksoy Derya

    İnönü University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 25, 2022

Study Start

February 5, 2020

Primary Completion

February 5, 2021

Study Completion

June 5, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

we don't share individual participant data with other researchers

Locations