The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding

The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding. The Mindful breastfeeding program intervention will be compared to the group receiving basic breastfeeding education. The main hypothesis is that pregnant women included in the mindful breastfeeding program have higher postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Feeding; Mindfulness; Psychological Well-Being
• Intervention / Treatment: Behavioral: Mindful Breastfeeding Program

Detailed Description

The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding.

There will be two groups in the study:

The web-based "Mindful Breastfeeding Program" (mindfulness-based breastfeeding program) consisting of 8 sessions in total, 2 sessions per week for 4 weeks, will be applied to the pregnant women who make up the intervention group. During the research, a QR code supported website will be established in order to support the awareness practices of the participants at home. While doing mindfulness practices at home, participants will be able to benefit from the short training videos on the website or the audio recordings prepared by the researcher with his own voice.

Only one session online breastfeeding training will be given to the control group and the training brochure for this training will be delivered to the participants via whatsapp.

A total of 40 pregnant women, 20 in the intervention group and 20 in the control group, will form the sample of the study. The main hypothesis is that the postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy of pregnant women included in the mindful breastfeeding program is higher than the pregnant women who participated in the single-session basic breastfeeding training.

Statistical analysis of the data obtained from the research will be made using SPSS (Statistical Packet for Social Science) for Windows 25.0 program.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özge Şiir Dağlar, PhD student; Phone Number: +90 544 226 45 85; Email: ozgesiirdaglar@gmail.com
• Study Contact Backup: Name: İlkay Güngör Satılmış, Associate professor; Phone Number: +90 535 646 47 68; Email: ilkay1979@yahoo.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa
    • Contact: Özge Şiir Dağlar, PhD student; Phone Number: +90 544 226 45 85; Email: ozgesiirdaglar@gmail.com
    • Contact: İlkay Güngör Satılmış, Associate professor; Phone Number: +90 535 646 47 68; Email: ilkay1979@yahoo.com
    • Principal Investigator: İlkay Güngör Satılmış, associate professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Research

• Able to communicate in Turkish,
• Being literate,
• Over 18 years old,
• Having primigravida,
• Conceiving naturally,
• Gestational week between 28-32 weeks,
• Having a single baby (no multiple pregnancy),
• Intention to breastfeed their baby after birth,
• The mother and her baby do not have any health problems,
• Having a smart phone and wireless internet,
• All pregnant women who score below 5 points in the depression sub-dimension, below 4 points in the anxiety sub-dimension, and below 8 points in the stress sub-dimension according to DASS-21 will be included in the sample.

Exclusion Criteria

• If the participant states that he/she wants to withdraw from the research,
• Not attending at least two training sessions,
• Premature birth (before 37 weeks of pregnancy),
• Not breastfeeding the baby after birth,
• Not participating in the post-test,
• Failure to complete the follow-up period for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention Group; A web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks. Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program. A web site with written material, video and audio recordings will be created and presented to the participants as a support element. In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period.	Behavioral: Mindful Breastfeeding Program; A web-based "Mindful Breastfeeding Program", which is applied to pregnant women in groups of 5, consisting of 8 sessions, 2 sessions per week for 4 weeks. Mindful breastfeeding program will consist of breastfeeding education, introduction to the concept of mindfulness, mindful breastfeeding, practical suggestions to pregnant women by the researcher, providing a discussion environment for them to share their experiences, and homework on the content of the program. A web site with written material, video and audio recordings will be created and presented to the participants as a support element. In order for them to use mindfulness practices in their daily lives, motivational WhatsApp short messages will be sent by the researcher daily during the training, weekly during the post-training period, and daily in the postpartum period.
No Intervention: Control Group; Only one session online breastfeeding training will be given and the training brochure for this training will be delivered to the participants via whatsapp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mindful Breastfeeding Scale	Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Breast Feeding Adaptation Scale	Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Self-Efficacy Scale	Mindful breastfeeding program at 1 month postpartum in intervention group and control group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Information Form		Mindful breastfeeding program pre-intervention in intervention group and control group.
Antenatal Breastfeeding Self-Efficacy Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindfulness Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindfulness Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Evaluation Form	A form developed by the researcher to evaluate the breastfeeding status of mothers in the first 7 days after birth (average between 3-5 days).	Mindful breastfeeding program within the first 7 days postpartum in the intervention group and control group.
System Usability Scale	The usability of the website will be evaluated by the participants in the intervention group at the last session of the training program using the System Usability Scale (SUS).	Immediately after intervention in the Mindful breastfeeding program intervention group.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Health Institutes of Turkey

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Breast Feeding; Psychological Well-Being
• Other Study ID Numbers: IUC-OSDaglar-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No