NCT05663567

Brief Summary

The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy: A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design. In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature. Question 1: Is a solution-oriented approach effective in increasing mothers' breastfeeding self-efficacy?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

October 26, 2022

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Increasing mothers' "breastfeeding self-efficacy scale score"

    increase in breastfeeding success of lactating puerperant women (After the solution-oriented approach application, the breastfeeding self-efficacy scale The Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert-Type scale with 1= "I am not sure at all" and 5 = "I am always sure". As Bandura (1998) suggested, all items are positive. The minimum score that can be obtained from the scale is 14, and the maximum is 70.

    12 weeks

  • Increasing "Latch breastfeeding scale score"

    After the solution-oriented approach application, the latch breastfeeding scale will be evaluated. Each item is evaluated between 0-2 points. The total score that can be taken from the scale is 10. The measurement tool has no cut-off point and the higher the LATCH score, the higher the success of breastfeeding.

    12 weeks

Study Arms (3)

experimental group 1

EXPERIMENTAL

Implementing a solution-focused approach to support breastfeeding ONE TO ONE STUDY

Behavioral: solution oriented approach

experimental group 2

EXPERIMENTAL

Implementing a solution-focused approach to support breastfeeding GROUP STUDY

Behavioral: solution oriented approach

No Intervention

NO INTERVENTION

ROUTINE MAINTENANCE WILL BE DONE SOLUTION-FOCUSED APPROACH WILL NOT BE APPLIED.

Interventions

Implementing a solution-focused approach to support breastfeeding

experimental group 1experimental group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years old, literate,
  • Can speak Turkish,
  • Primiparous and at term and healthy delivery (38-42 weeks, 2500-4000g born, 5th minute APGAR score of 7 and above, no known congenital disease),
  • Women who do not have a chronic disease that prevents breastfeeding in their baby or in themselves
  • Does not have a systemic disease,
  • Those who have never received a planned breastfeeding training before,
  • Having a healthy pregnancy,
  • Planning to breastfeed,
  • Women who have internet access, devices with internet usage (smartphone, computer, tablet, etc.), who have Zoom and Google Meet video conferencing applications on these devices.
  • Women who can be reached within one week at the latest after giving birth

You may not qualify if:

  • Women who do not want to breastfeed
  • Women who have a disability to breastfeed
  • Expressing that they cannot continue to work until the end,
  • Women who did not participate and did not answer the post-test of the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmnagazi Universty

Eskişehir, Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • özlem CAGAN, PHD

    ocagan@ogu.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ESRA NUR KABAKCI, PHD

CONTACT

özlem CAGAN, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSİSTMENT

Study Record Dates

First Submitted

October 26, 2022

First Posted

December 23, 2022

Study Start

January 30, 2024

Primary Completion

April 26, 2024

Study Completion

April 30, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

After the research results are analyzed and published, access can be made.

Shared Documents
SAP, ICF
Time Frame
10.08.2023-10.08.2024
Access Criteria
Anyone who works in a similar field, who is interested in this field

Locations