NCT05562245

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

September 19, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

September 19, 2022

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Rate of feeding the baby with only breast milk

    3 months

  • Total breastfeeding time

    3 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

1. 1st hour after cesarean section Pre-tests and motivational interviewing-based breastfeeding education 2. Postpartum 5-7th Day: When the mothers come to the hospital for control, a second motivational interviewing session will be held in the breastfeeding room and breastfeeding will be supported when necessary and a second measurement will be made. 3. Postpartum 6th Week: The third motivational interviewing session will be held by going to the mothers' homes, breastfeeding will be supported when necessary and a third measurement will be made. 4. Postpartum 3rd Month: In order to end the motivational interviewing, the fourth motivational interviewing session will be held by going to the mothers' homes and the fourth measurement will be made.

Other: Motivational Interviewing-Based Breastfeeding Education

Control arm

NO INTERVENTION

1st hour after cesarean section will be made pre-tests and routine breastfeeding training of the hospital will be given to mothers in the control group. Mothers will be followed up 5-7th days postpartum, postpartum 6th week, and postpartum 3rd month

Interventions

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum mothers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana Konya Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Halime Esra Meram, PhD

    esrameran@selcuk.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned in a randomized controlled experimental design to evaluate the effect of motivational interviewing-based breastfeeding education on breastfeeding motivation, breastfeeding success and breastfeeding self-efficacy perception of primiparous mothers after cesarean section.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 30, 2022

Study Start

September 19, 2022

Primary Completion

March 30, 2023

Study Completion

October 10, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations