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

August 29, 2023 updated by: Özge Şiir Dağlar, Istanbul University - Cerrahpasa (IUC)
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • İstanbul University-Cerrahpaşa
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mindful Breastfeeding Scale
Time Frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Breast Feeding Adaptation Scale
Time Frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Self-Efficacy Scale
Time Frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindful breastfeeding program at 1 month postpartum in intervention group and control group.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic Information Form
Time Frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindful breastfeeding program pre-intervention in intervention group and control group.
Antenatal Breastfeeding Self-Efficacy Scale
Time Frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Time Frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindful breastfeeding program pre-intervention in intervention group and control group.
Depression, Anxiety, Stress Scale
Time Frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindfulness Scale
Time Frame: Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindful breastfeeding program pre-intervention in intervention group and control group.
Mindfulness Scale
Time Frame: Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Mindful breastfeeding program at 1 month postpartum in intervention group and control group.
Postpartum Breastfeeding Evaluation Form
Time Frame: Mindful breastfeeding program within the first 7 days postpartum in the intervention group and control group.
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
Time Frame: Immediately after intervention in the Mindful breastfeeding program intervention group.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Institutes of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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