NCT06713109

Brief Summary

The primary aim of this study was to investigate the effect of motivational interviewing technique on breastfeeding problems and loss. H1:The breastfeeding problems score of the mothers who received motivational interviewing was lower than the mothers who received standard care. H 2: The anxiety level score of mothers who received motivational interviewing is lower than that of mothers who received standard care. H3: The rate of exclusive breastfeeding of mothers who received motivational interviewing is higher than that of mothers who received standard care.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 7, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

breastfeedingmotivational interviewinganxiety

Outcome Measures

Primary Outcomes (2)

  • The effect of motivational interviewing on breastfeeding

    Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.

    three weeks from the start of the interview

  • The effect of motivational interviewing on anxiety

    Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.

    three weeks from the start of the interview

Study Arms (2)

arm1

NO INTERVENTION

Will receive standard breastfeeding training and after 3 weeks the final test will be administered

arm2

EXPERIMENTAL

A motivational interview will be conducted to get information about the breastfeeding problem and the level of loss and to try to support it with interviews.

Behavioral: Motivational interview techniques

Interventions

Motivational interviews will be conducted 4 times. As a result of these interviews, the breastfeeding problem or anxiety in the mother will be evaluated and the effectiveness of the interview will be solved.

arm2

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNursing mothers with a 1-month-old baby
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having a healthy 1-3 month old baby
  • Being identified as having a breastfeeding problem
  • To be at least primary school graduate
  • To be able to communicate by telephone
  • To come to the Family Health Centre for motivational talks

You may not qualify if:

  • Having a baby with anomalies
  • Having a baby younger than 1 month and older than 3 months
  • Having a medical illness that prevents breastfeeding
  • Communication problems
  • Not accepting motivational interviewing
  • The presence of any psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara Üniversitesi Pendik Eğitim Aile Sağlığı Merkezi

Istanbul, tuzla, 34860, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingAnxiety Disorders

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: breastfeeding problems anxiety motivational interviewing
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

November 7, 2024

First Posted

December 3, 2024

Study Start

September 1, 2024

Primary Completion

December 27, 2024

Study Completion

January 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations