NCT06971302

Brief Summary

Pregnant women followed at the Tece Family Health Center were contacted via telephone and informed about the study. Pregnant women who expressed interest in participating were assessed according to the inclusion and exclusion criteria using the "Eligibility Assessment Form" prepared by the researcher. Those who met the research criteria were randomly assigned to either the intervention or the control group. Before starting the Mindfulness-Based Breastfeeding Education, all participants in both groups were asked to complete the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale. The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher, both face-to-face and online, on predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make the content more memorable and easier to understand. After the final session of the six-week training program, the participants completed the Antenatal Breastfeeding Self-Efficacy Scale. Mothers were asked to inform the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale. No intervention was applied to the pregnant women in the control group. Six weeks after the first administration of the Antenatal Breastfeeding Self-Efficacy Scale, the same scale was administered again. Mothers were asked to notify the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following forms and scales were administered: Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool, and Mindful Breastfeeding Scale. In order to eliminate any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group after the data collection process had been completed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

August 8, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

April 17, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

minfulnessnursing carebreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding evaluated using the Antenatal Breastfeeding Self-Efficacy Scale

    The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher breastfeeding self-efficacy.

    during pregnancy, when the study was started and 6 weeks later

  • Breastfeeding evaluated using the Postnatal Breastfeeding Self-Efficacy Scale

    The lowest possible score on the scale is 14, and the highest possible score is 70. There is no cut-off point for the scale, and an increase in the score indicates higher Change from breastfeeding self-efficacy.

    Change from postpartum 1st and 8th week

Secondary Outcomes (1)

  • Breastfeeding evaluated using the Bristol Breastfeeding Assessment Tool

    Change from postpartum 1st and 8th week

Other Outcomes (1)

  • Breastfeeding evaluated using the Mindful Breastfeeding Scale

    Change from postpartum 1st and 8th week

Study Arms (2)

Control

NO INTERVENTION

Initially, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.No intervention was applied to the pregnant women in the control group. After the first application of the Prenatal Breastfeeding Self-Efficacy Scale, the same scale was applied again six weeks later. Participants were asked to notify the researcher when they gave birth. The following instruments were applied to mothers at 1 and 8 weeks postpartum: * Postpartum Mother-Baby Identifier Form, * Postpartum Breastfeeding Self-Efficacy Scale, * Bristol Breastfeeding Assessment Tool, and * Mindful Breastfeeding Scale. In order to eliminate possible ethical concerns regarding the control group, breastfeeding education was provided to mothers in the control group after the data collection process was completed.

Mindfulness based breastfeeding education

EXPERIMENTAL

Before the Mindfulness-Based Breastfeeding Education began, the pregnant women were administered the Informed Consent Form, the Pregnant Women's Descriptive Characteristics For.The Mindfulness-Based Breastfeeding Education was delivered to the pregnant women in the intervention group by the researcher both face-to-face and online on the predetermined days and times. The training was supported with visual presentations, videos, and models prepared by the researcher to make it memorable and easy to understand. After the final session of the six-week training program, the Antenatal Breastfeeding Self-Efficacy Scale was administered to the participants. The mothers were asked to inform the researcher when they gave birth. In the 1st and 8th weeks postpartum, the following forms and scales were administered to the mothers: * Postpartum Mother-Infant Descriptive Form, * Postnatal Breastfeeding Self-Efficacy Scale, * Bristol Breastfeeding Assessment Tool, * Mindful Breastfeeding Scale.

Other: Mindfullnes Based Breastfeeding Education

Interventions

Pregnant women in the intervention group will receive mindfulness-based breastfeeding training, conducted face-to-face and online by the researcher at designated days and times. The intervention group will undergo a total of 12 sessions of mindfulness-based breastfeeding training over a six-week period. The training will be made memorable and easy to understand through the support of visual presentations, videos, and models prepared by the researcher.

Mindfulness based breastfeeding education

Eligibility Criteria

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

You may qualify if:

  • For pregnant women:
  • Who are 18 years or older,
  • Who are literate,
  • Who are in their 24th to 28th week of pregnancy,
  • Who are expecting a singleton pregnancy,
  • Who are willing to participate in the study,
  • Whose breastfeeding self-efficacy score is below 57,
  • Who agree to home visits postpartum for interviews,
  • Who do not have any health issues that would prevent breastfeeding,
  • Who do not have any communication barriers.

You may not qualify if:

  • For pregnant women who:
  • Are under 18 years old,
  • Are illiterate,
  • Have a gestational age less than 24 weeks or greater than 28 weeks,
  • Have a multiple pregnancy,
  • Do not wish to breastfeed,
  • Have any health issues that would prevent breastfeeding (such as mastectomy, medication use, HIV, etc.),
  • Do not speak Turkish,
  • Have any psychiatric issues,
  • Have a breastfeeding self-efficacy score higher than 57,
  • Cannot attend more than two sessions for any reason during the study period,
  • Are illiterate,
  • Do not sign the Informed Consent Form,
  • Do not agree to home visits postpartum for interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • DUYGU VEFİKULUÇAY YILMAZ, PROF

    Mersin University Faculty of Nursing

    STUDY CHAIR
  • ÖZGE DALGALAR, MASTER

    Mersin University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomize control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist nurse

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 14, 2025

Study Start

August 8, 2024

Primary Completion

March 25, 2025

Study Completion

August 12, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations