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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06035419
Other study ID # PAU SBF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2019
Est. completion date February 15, 2020

Study information

Verified date September 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Feeding the infant with breast milk in neonatal intensive care units is essential. However, breastfeeding can be adversely affected in this complex environment, especially for immigrant mothers. In order to ensure the success of breastfeeding in the neonatal intensive care unit, education and support of the mother are required. While doing this, structured and planned education programs should be implemented taking into account the individual characteristics of the mother (culture, age, etc.).This study aimed to evaluate the effect of education given to immigrant mothers on breastfeeding success of mothers. The study was a randomized controlled, single-blind clinical trial.


Description:

This study aimed to evaluate the effect of education given to immigrant mothers on breastfeeding success of mothers. Method: In this randomized-controlled, single-blind study, 80 immigrant mothers (40 intervention groups, 40 control groups) were recruited. The study included primiparous immigrant mothers whose mother tongue was not Turkish, whose baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of gestation, whose baby was fed orally, and whose suckling was not impaired. In the study, 40 participants were included in the experimental group and 40 participants in the control group. At the end of the study, Cohen's d was calculated to determine the effect size and was found to be 1.80. A simple randomization method was used to randomly assign the mothers included in the study to the experimental and control groups. To avoid bias in the study, a nurse who was not involved in the study made the LATCH scoring and evaluation of the suckling time and feeding style of the infants, without knowing which group the mothers were in. In addition, mothers to be included in the experimental and control groups were determined by a simple randomization method to prevent selection bias in the study. Mother-baby information form, Nutrition follow-up form, and LATCH were used to collect the study data. The mothers to be included in the study were informed by an interpreter before the study and their consent was obtained. It was ensured that the mothers in both groups answered the questions in the data collection forms through a translator. Information about the baby was taken from the patient's file. A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group. In the control group, no interventions were made except for the routine interventions of the clinic (unstructured training practices given by the individual effort of the nurse). The first of the parameters used to evaluate breastfeeding success is the mothers' LATCH score averages. LATCH scores of mothers were evaluated by observation. LATCH evaluations of the mothers in the experimental group were made at the first breastfeeding before the training and on the 1st, 2nd, and 3rd days after the training. The LATCH evaluations of the control group were made at the first breastfeeding and on the 1st, 2nd, and 3rd days. Another parameter examined to evaluate breastfeeding success is the suckling time of babies at each breastfeeding. The suckling time of the babies was measured with a stopwatch at each feeding. The last of the parameters to evaluate breastfeeding success is the feeding style of infants. Information about the feeding style of infants was obtained from the nurse observation form.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 15, 2020
Est. primary completion date February 7, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Immigrant mothers whose baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of gestation, whose baby was fed orally and who did not prevent suckling, whose mother tongue was not Turkish, and who volunteered to participate in the study. Exclusion Criteria: - Migrant mothers whose babies were hospitalized in the NICU before, whose baby was younger than 34 weeks of gestation, whose baby was not fed orally, who were not primiparous, and who did not volunteer to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
education
breastfeeding education for migrant mothers

Locations

Country Name City State
Turkey Pamukkale University Denizli Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary LATCH score LATCH was used to evaluate breastfeeding success. Each item is evaluated between 0-2 points. The total score that can be obtained from the vehicle is 10, and a high score means high breastfeeding success. Evaluation is done through observation. 3 days
Primary sucking time of babies To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding. 3 days
Primary feeding type of babies Information about the feeding style of infants was obtained from the nurse observation form. The characteristics for the type of nutrition are; breastfeeding only, spoon feeding only, spoon feeding and breastfeeding together. 3 days
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