NCT05682014

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

December 27, 2022

Last Update Submit

August 29, 2023

Conditions

Keywords

MindfulnessBreast FeedingPsychological Well-Being

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (2)

İntervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

İntervention Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingPsychological Well-Being

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPersonal Satisfaction

Central Study Contacts

Özge Şiir Dağlar, PhD student

CONTACT

İlkay Güngör Satılmış, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

November 1, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations