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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06313034
Other study ID # GU-SBF-OPA-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date March 15, 2024

Study information

Verified date March 2024
Source Gümüshane University
Contact ÖZGE PALANCI AY
Phone 05428933629
Email ozge.plnci@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial.


Description:

The study will be conducted as a single-blind, randomized controlled trial with 80 mothers who gave birth vaginally. In the experimental group, just before discharge from the hospital (within the last 4 hours before discharge), on the 2nd-5th, 13th-17th, 30th-42nd days after birth. Breastfeeding training based on motivational interviewing technique will be given 4 times in total. The control group will continue to receive the current standard care and service of the relevant hospital and other postpartum health institutions. Hypotheses of the Research 1. The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the mother's breastfeeding motivation. are there?(H1) 2. Breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique has no effect on increasing the mother's breastfeeding self-efficacy. Does it have any effect?(H2) 3. The effect of breastfeeding education given to mothers who gave birth vaginally with motivational interviewing technique on increasing the level of mother-infant attachment. are there?(H3)


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: Maternal criteria; - Agreeing to participate in the research - Being 20 years or older - Having had a vaginal birth - being primiparous - Being at least a primary school graduate - Ability to speak Turkish - Not having any condition that would prevent communication - No medical breast problem Criteria for the baby; - Being born at term (38-41 gestational weeks) - There is no congenital anomaly such as cleft palate or lip of the newborn that may prevent sucking. - Birth weight over 2500 grams Exclusion Criteria: Maternal criteria; - Having a chronic disease that prevents breastfeeding - Having major breast problems that will prevent breastfeeding - The mother has a diagnosed psychiatric disease - Having 2 or more live newborns in this birth Criteria for the baby; - Premature birth (37th gestational week and before) - Having a congenital disease - Being in the risk group/being diagnosed with a disease in the newborn screening program

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Breastfeeding education based on motivational interviewing technique
Breastfeeding education based on motivational interviewing technique; Breast milk properties, benefits to mother and baby, breastfeeding positions, the relationship between breastfeeding and attachment, signs of hunger in the newborn, Breastfeeding frequency, duration and termination, Breast milk expressing methods, Expressions showing that the newborn has enough milk, Breast milk storage will cover the topics. These topics will be given based on motivational interviewing technique. According to the motivational interviewing technique, the mother's "intention, importance and confidence-sufficiency" regarding breastfeeding will be determined and firstly, an agenda will be created on "issues related to breastfeeding with the mother". Each session will be conducted by following the "open-ended questioning, verification, reflective listening and summarizing" approaches of the motivational interviewing technique.

Locations

Country Name City State
Turkey Gümüshane University Gümüshane

Sponsors (2)

Lead Sponsor Collaborator
Gümüshane University Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mother Introductory Information Form It was prepared in line with the literature. The form consists of a total of 27 questions, including information about socio-demographic information, obstetric, newborn characteristics.breastfeeding characteristics one day
Primary Primipara Breastfeeding Motivation Scale It was developed to determine the factors affecting breastfeeding motivation in primiparous women. The scale is a 7-point Likert type, consisting of a total of 29 items and 4 sub-dimensions. These sub-dimensions; the value placed on breastfeeding, self-efficacy, perceived midwife support and expectation of success. There is no cut-off value and total score in the evaluation of the scale. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases. Three months
Primary Breastfeeding Self-Efficacy Scale Short Form The scale is a 5-point Likert type and consists of 14 questions in total. The lowest score that can be obtained from the scale is 14 and the highest score is 70. High scores are interpreted as high breastfeeding self-efficacy. Three months
Primary Mother-Baby Attachment Scale The scale has a total of 8 items and is a 4-point Likert type. Responses are scored between 0-3. In the evaluation, items with positive emotion expressions (1, 4, 6.) were scored as 0, 1, 2, 3, while items with negative emotion expressions (2, 3, 5, 7, 8.) were scored as 3, 2, 1,0. It is scored as. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score obtained from the scale increases, the level of mother-infant attachment decreases Three months
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