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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05562245
Other study ID # 2022/28
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2022
Est. completion date October 10, 2023

Study information

Verified date January 2024
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The general purpose of this project is; to evaluate effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section. The sub-aims of the study were to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding outcomes of primiparous mothers who gave birth by cesarean section. The study will be conducted between September 2022- March 2023 at Konya a private hospital.


Description:

The research was planned as a randomized controlled experimental study. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. A total of 80 primiparous mothers who gave birth by cesarean section, 40 in the experimental group and 40 in the control group, will be included in the study. Pre-Test Information Collection Form at the 1st hour after Caesarean section, Postpartum 5-7. Day Follow-up Form, Postpartum 6th Week Follow-Up Form and Postpartum 3rd Month Follow-up Form, LATCH Breastfeeding Assessment Tool, Breastfeeding Self-Efficacy Short Form Scale, The Primipara Breastfeeding Motivation Scale, Confidence-sufficiency and importance a scale. Breastfeeding education based on motivational interviewing will be held for mothers in the experimental group, 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. Routine breastfeeding training of the hospital will be given to mothers in the control group 1st hour after cesarean section and will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month. At the end of the study, the results of the mothers in the experimental and control groups will be evaluated. The breastfeeding guide prepared by the researcher will be given to the mothers in the experimental and control groups.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 10, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteer to participate in the study, - Cesarean delivery, - Does not have a condition that prevents breastfeeding, - Married - Primiparous, - Not receiving general anesthesia, - At least primary school graduate, - 18 years and above, - Do not have any chronic disease, - The birth weight of the baby is 2500 g and above, - Your baby's APGAR score is 7 and above in the 5th minute, - Mothers whose babies do not have congenital and/or metabolic diseases will be included in the study. Exclusion Criteria: - Having multiple pregnancy and giving birth, - Foreign nationals and do not speak Turkish, - Having a history of preeclampsia, eclampsia and gestational diabetes, - Mothers who develop complications during cesarean section and whose transfer to the service exceeds 1 hour (because breastfeeding will be delayed for the first hour), - COVID-19 positive in the 1st hour after birth and having a condition that prevents breastfeeding, - Those with a history of diagnosed mental or psychiatric illness will not be included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motivational Interviewing-Based Breastfeeding Education
Motivational interviewing is basically a directive and client-centered psychosocial intervention used to help individuals discover and analyze ambivalent emotions related to their health behaviors, to learn new skills and to improve their existing skills. One of the main guiding principles in motivational interviewing is self-support and empowerment. The interviews consist of one to four sessions lasting between 7.5-60 minutes. A total of four motivational interviews will be held with the mothers in the experimental group.

Locations

Country Name City State
Turkey Medicana Konya Hospital Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary LATCH Breastfeeding Assessment Tool The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. Change from LATCH Breastfeeding Assessment Tool at 3 months
Primary Breastfeeding Self-Efficacy Short Form Scale The scale consists of 33 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained Change from Breastfeeding Self-Efficacy Short Form Scale at 3 months
Primary The Primipara Breastfeeding Motivation Scale The Primipara Breastfeeding Motivation Scale: The scale consists of 29 items and is scored between 1-7. It has a total of four sub-dimensions. Evaluation is made by summing the scores obtained in each subgroup in the scale. Change from The Primipara Breastfeeding Motivation Scale at 3 months
Primary Confidence- sufficiency and importance a scale It is a grading scale prepared in the form of a visual analog scale. The score that can be obtained from the scale varies in the range of 0-10 points. Change from Confidence- sufficiency and importance a scale at 3 months
Secondary Rate of feeding the baby with only breast milk 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month 3 months
Secondary Total breastfeeding time 1st hour after cesarean section, 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month 3 months
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