NCT05221463

Brief Summary

Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success. Hypotheses Hypothesis 01: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns does not affect breastfeeding self-efficacy of mothers. Hypothesis 1: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases mothers' breastfeeding self-efficacy. Hypothesis 02: Video-assisted breast milk and breastfeeding education given to mothers of hospitalized newborns does not affect mothers' breastfeeding success. Hypothesis 2: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases the breastfeeding success of mothers. This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey. In the study, mothers who met the inclusion criteria were assigned to the education group (EG) (n=44) and the control group (CG) (n=44), some mothers did not continue the education program and left the study. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG. Video assisted breastfeeding training was given to the intervention group. Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made.Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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

June 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

January 22, 2022

Last Update Submit

February 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding self-efficacy change

    As assessed by the Postpartum Breastfeeding Self-Efficacy Scale-Brief Form.The scale assesses how competent mothers feel about breastfeeding. The lowest score that can be obtained from the scale is 14, and the highest score is 70. The higher the score, the higher the breastfeeding self-efficacy.

    At baseline and at the end of the 3nd day of study, breastfeeding self-efficacy was assessed

  • Breastfeeding success change

    As assessed by the LATCH (Latch on breast, Audible swallowing, Type of nipple, Comfort bresat/nipple, Hold) Breastfeeding Diagnostic Measurement Tool. The scale consists of five evaluation criteria \[L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)\]. Each item is evaluated between 0 and 2 points. A maximum of 10 points can be obtained from the scale. As the score obtained from the scale increases, the success of breastfeeding increases.

    At baseline and at the end of the 3nd day of study, breastfeeding success was assessed

Study Arms (2)

Educational group

EXPERIMENTAL

Video-assisted breastfeeding training was given to the educational group.

Behavioral: Video-assisted breastfeeding training

Control group

OTHER

Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made.

Behavioral: The hospital's routine general breastfeeding training

Interventions

Breastfeeding training was given to the experimental group for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and routinely used by nurses in breast milk training in neonatal units. During the training, mothers were allowed to watch breast milk and breastfeeding training videos. On the third day after the training, feedback was received from the applications in the video regarding the knowledge and skills of the mother, and the mother's questions were answered.

Educational group

The control group was given the hospital's general breastfeeding training for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and used routinely by nurses in breast milk training in neonatal units, and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made.

Control group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • wanting to participate
  • healthy
  • years and older
  • the baby is hospitalized and breastfed by the neonatologist is deemed appropriate
  • able to read and write
  • no psychiatric problems
  • mothers who speak Turkish

You may not qualify if:

  • unwilling to participate
  • patient
  • breast-feeding not approved by the neonatologist
  • having breast problems that prevent breastfeeding
  • mental, cognitive, psychiatric, hearing and vision problems
  • illiterate
  • mothers who do not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University Health, Application and Research Center

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Nazlı Baltacı, phD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • Esra Tural Büyük, phD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, phD

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 3, 2022

Study Start

June 1, 2021

Primary Completion

December 25, 2021

Study Completion

December 25, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from the corresponding author (E.T.B.) upon reasonable request.

Locations