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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05682014
• Other study ID #: IUC-OSDaglar-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Özge Siir Daglar, PhD student
• Phone: +90 544 226 45 85
• Email: ozgesiirdaglar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding
• Mindfulness
• Psychological Well-Being

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Health Institutes of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mindful Breastfeeding Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Primary	Breast Feeding Adaptation Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Primary	Postpartum Breastfeeding Self-Efficacy Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Secondary	Sociodemographic Information Form		Mindful breastfeeding program pre-intervention in intervention group and control group.
Secondary	Antenatal Breastfeeding Self-Efficacy Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Secondary	Depression, Anxiety, Stress Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Secondary	Depression, Anxiety, Stress Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Secondary	Mindfulness Scale		Mindful breastfeeding program pre-intervention in intervention group and control group.
Secondary	Mindfulness Scale		Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Secondary	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.
Secondary	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.