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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05221463
Other study ID # 360
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 25, 2021

Study information

Verified date February 2022
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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. The education given to the mother by health care professionals; It has a great effect on the initiation and maintenance of breastfeeding, prevention of breast complications and successful breastfeeding. 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. 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. The universe of the study consisted of mothers who were hospitalized in the neonatal intensive care unit of the hospital where the study was conducted between 01.06.2021 and 25.12.2021 and came to breastfeed. Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples.In the calculation made by assuming that the evaluations to be made between two independent groups will have a large effect (d=0.80) on the Breastfeeding Self-Efficacy Scale-Short Shape scale scores (Tokat et al. 2010), in order to obtain 80% power (1-β) at the α=0.05 level. It was determined that there should be at least 36 people in each group. Considering that there may be losses during the research process, it was planned to recruit 44 people to each group. Three of the mothers (n=44) who met the inclusion criteria and were included in the training group (EG), and one of the mothers (n=44) who were included in the control group (KG) dropped out of the study by not continuing the training program. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG. The suitability of the mothers who came to the neonatal intensive care unit to breastfeed their babies was evaluated by the researcher. The mothers who were willing and able to participate in the study were given the necessary information about the study and their written consent was obtained. The study had an intervention and a control group. The researcher first gave video-assisted breastfeeding training to the intervention group for 3 days. 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. When these trainings were completed, other eligible mothers were included in the control group. The control group was given only the hospital's routine general breastfeeding training for 3 days and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made. First of all, sociodemographic and obstetric data of the mothers were collected by using the introductory information form, and information about the infants was obtained by the researcher from the infants' files. 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) before the training was given. Before starting this study, ethics committee approval was obtained from the Clinical Research Ethics Committee of a University in northern Turkey (decision dated 28/05/2021, numbered 2021/239) and written permission from the relevant institution where the study was conducted. In addition, the purpose of the study was explained to all participants before the data collection form was applied, and written informed consent was obtained from those who volunteered to participate in the study.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date December 25, 2021
Est. primary completion date December 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility Inclusion Criteria: - wanting to participate - healthy - 18 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video-assisted breastfeeding training
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.
The hospital's routine general breastfeeding training
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.

Locations

Country Name City State
Turkey Ondokuz Mayis University Health, Application and Research Center Samsun

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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