Effect of Mindfulness Based Breastfeeding Education on Mothers' Breastfeeding Parameters

NCT ID: NCT06971302

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2025-08-12

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.

Detailed Description

The content of the Mindfulness-Based Breastfeeding Education was developed by the researchers based on a comprehensive review of the relevant literature. To evaluate the appropriateness of the educational content, feedback was obtained from expert faculty members with academic experience in breastfeeding and/or mindfulness-related studies.

A list of pregnant women being followed at the Tece Family Health Center was compiled, and those who were interested in participating were provided with general information about the study. Additionally, the researcher shared her contact information with these pregnant women.

Pregnant women who expressed willingness to participate and contacted the researcher were assessed for eligibility using a "Eligibility Assessment Form" prepared by the researcher. Those who met the inclusion criteria were randomly assigned to either the intervention or the control group. The participants were then asked to complete the Informed Consent Form, Pregnant Women's Descriptive Characteristics Form, and the Antenatal Breastfeeding Self-Efficacy Scale.

To facilitate communication with the intervention group, a WhatsApp group was created. Taking into account the needs of the participants and previous studies, appropriate days and times were scheduled for the six-week Mindfulness-Based Breastfeeding Education Program, consisting of weekly two-hour sessions. Participants in the intervention group were divided into subgroups of no more than seven individuals each.

In total, the intervention group received 12 sessions of mindfulness-based breastfeeding education, delivered according to the scheduled days and times. To minimize participant dropout, the program was delivered over six weeks, with the first three weeks conducted online and the remaining three weeks conducted face-to-face, each session lasting two hours.

The educational content covered the following themes: introduction to mindfulness, awareness of the body and the "automatic pilot" mode, mindful communication, coping with difficult emotions and situations, integrating mindfulness into daily life, the postpartum period, and the themes of closure and new beginnings. Mindfulness practices were integrated into the breastfeeding experience under each theme.

No intervention was applied to the control group during the six-week period. At the end of the six weeks, both the intervention and control groups completed the Antenatal Breastfeeding Self-Efficacy Scale once again.

After childbirth, mothers whose newborns did not meet the inclusion criteria were excluded from the sample, and new participants were recruited accordingly. IIn the 1st and 8th weeks postpartum, the Postpartum Mother-Infant Descriptive Form, Postnatal Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Assessment Tool (BBAT), and the Mindful Breastfeeding Scale (MIND-BFS) were administered to both the intervention and control groups.

To address any potential ethical concerns related to the control group, breastfeeding education was provided to the mothers in the control group following the completion of data collection.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mindfulness based breastfeeding education

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.

Group Type: EXPERIMENTAL

Mindfullnes Based Breastfeeding Education

Intervention Type: OTHER

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.

Interventions

Mindfullnes Based Breastfeeding Education

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Ozge Dalgalar

Specialist nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DUYGU VEFİKULUÇAY YILMAZ, PROF

Role: STUDY_CHAIR

Mersin University Faculty of Nursing

ÖZGE DALGALAR, MASTER

Role: PRINCIPAL_INVESTIGATOR

Mersin University Faculty of Nursing

Locations

Turkey, Mersin University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

78017789/050.01.04/2621454

Identifier Type: -

Identifier Source: org_study_id