Clinical trial NCT05682014: The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding
Official title: The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mindfulness
Breast Feeding
Psychological Well-Being
Keywords: Mindfulness
Breast Feeding
Psychological Well-Being
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2023-01-12
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random sampling method will be used in the research. Randomization Pregnant women will be evaluated in terms of their eligibility for the study, a list of pregnant women included in the study will be created and divided into two groups. The assignment of pregnant women to the intervention and control groups in the study will be realized by assigning a number to each of the participants, forming a number group for the intervention group, and planning the numbers outside of this group as the control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mindful Breastfeeding Scale
timeFrame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
measure: Breast Feeding Adaptation Scale
timeFrame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
measure: Postpartum Breastfeeding Self-Efficacy Scale
timeFrame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Secondary outcomes:
measure: Sociodemographic Information Form
timeFrame: Mindful breastfeeding program pre-intervention in intervention group and control group.
measure: Antenatal Breastfeeding Self-Efficacy Scale
timeFrame: Mindful breastfeeding program pre-intervention in intervention group and control group.
measure: Depression, Anxiety, Stress Scale
timeFrame: Mindful breastfeeding program pre-intervention in intervention group and control group.
measure: Depression, Anxiety, Stress Scale
timeFrame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
measure: Mindfulness Scale
timeFrame: Mindful breastfeeding program pre-intervention in intervention group and control group.
measure: Mindfulness Scale
timeFrame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
measure: Postpartum Breastfeeding Evaluation Form
timeFrame: Mindful breastfeeding program within the first 7 days postpartum in the intervention group and control group.
measure: System Usability Scale
timeFrame: Immediately after intervention in the Mindful breastfeeding program intervention group.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: