The Effect of Breastfeeding Education Given by Pecha Kucha Method

September 23, 2024 updated by: Filiz Ünal Toprak, Saglik Bilimleri Universitesi

The Effect of Antenatal Breastfeeding Education Given by Pecha Kucha Method on Postpartum Breastfeeding Self-Efficacy, Infant Feeding Attitude and Breastfeeding Satisfaction: a Randomized Controlled Study

To evaluate the effect of breastfeeding education given with Pecha Kucha method in the prenatal period on breastfeeding self-efficacy, infant feeding attitude and breastfeeding satisfaction in the postpartum period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings should be given starting from the prenatal period. In this study, breastfeeding training will be given to pregnant women with pecha kucha method in the prenatal period and the effect of breastfeeding training on postpartum breastfeeding self-efficacy, infant feeding attitude and breastfeeding satisfaction will be evaluated.

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 (Actual)

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.
75

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 Locations

  • Turkey
      • Ankara, Turkey, 6010
        • Ankara Etlik City Hospital

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteered to participate in the research,
  • To be able to speak and understand Turkish,
  • Over 18 years of age,
  • At least primary school graduate,
  • Gestational week 38 weeks and above
  • No chronic illness,
  • Pregnant women without communication barriers will be included in the study.

Exclusion Criteria:

  • Have a medical indication that prevents breastfeeding,
  • Multiple pregnancies,
  • A person with a mental illness,
  • Not wanting to continue the research process,
  • The one who still hasn't given birth 2 weeks after the training,
  • Not having their baby with them after childbirth,
  • Pregnant women who cannot be reached during the follow-up period will be excluded from the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Pecha Kucha Group
Pregnant women who meet the inclusion criteria assigned to the Pecha Kucha group will be informed about the study and their written and verbal consent will be obtained. Pregnant women will be asked to fill out the 'Introductory Characteristics Information Form', the 'Antenatal Breastfeeding Self-Efficacy Scale Short Form' and the 'Infant Feeding Attitude Scale (IOWA)' before the training at the first encounter, and then breastfeeding training prepared by the Pecha Kucha method will be given. 2 weeks after the training, she will be followed up by phone and asked to answer the Pospartum Breastfeeding Self-Efficacy Scale Short Form, Infant Feeding Attitude Scale (IOWA) and Visual Comparison Scale Satisfaction (VAS-M) scale. 4 weeks after the training, she will be asked to answer the Pospartum Breastfeeding Self-Efficacy Scale Short Form, Infant Feeding Attitude Scale (IOWA) and Visual Comparison Scale Satisfaction (VAS-M) scale.
Other: Pecha Kucha method
The Pecha Kucha method will be prepared in the form of a presentation consisting of 20 slides each shown for 20 seconds. The Pecha Kucha presentation lasts 6 minutes and 40 seconds, and most slides present only images. This method is planned to be used in breastfeeding education as it will be more memorable because it contains more visual, auditory and short information.
No Intervention: Control Group
Pregnant women who meet the inclusion criteria and who are assigned to the control group will be informed about the study and their written and verbal consent will be obtained. Pregnant women will be asked to fill out the 'Descriptive Characteristics Information Form', 'Antenatal Breastfeeding Self-Efficacy Scale Short Form' and 'Infant Feeding Attitude Scale (IOWA)' at the first encounter. After 2 weeks, she will be followed up by telephone and asked to answer the Pospartum Breastfeeding Self-Efficacy Scale Short Form, Infant Feeding Attitude Scale (IOWA) and Visual Comparison Scale Satisfaction (VAS-M). After 4 weeks, she will be asked to answer the Pospartum Breastfeeding Self-Efficacy Scale Short Form, Infant Feeding Attitude Scale (IOWA) and Visual Comparison Scale Satisfaction (VAS-M).

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
Measure Description
Time Frame
Antenatal and Pospartum Breastfeeding Self-Efficacy Scale Short Form
Time Frame: 0,2 and 4 weeks
The scale can be administered in prenatal and postnatal periods and measures how competent women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure, not very sure, sometimes sure, sure, very sure. The lowest score that can be obtained from all the evaluation scores of the scale is 14 and the highest score is 70. A low total score on the scale indicates a low perception of breastfeeding self-efficacy. In the original scale, the Cronbach's alpha reliability coefficient of the prenatal form was 0.87 and the Cronbach's alpha reliability coefficient of the postnatal form was 0.86.
0,2 and 4 weeks

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
Visual Assessment Scale - Satisfaction (VAS - S)
Time Frame: 2 and 4 weeks
The VAS is also used to measure other components besides pain, such as satisfaction.In our study, the VAS will also be used to assess mothers' breastfeeding satisfaction levels. The Visual Assessment Scale - Satisfaction (VAS-S) is a 10 cm ruler with the expression "Not satisfied" on one end and "Very satisfied" on the other end. The mother is asked to rate her satisfaction with breastfeeding after the training from 1 to 10. High scores on the scale indicate that the satisfaction of the recipients is also high.
2 and 4 weeks
Infant Feeding Attitude Scale (IOWA)
Time Frame: 0,2 and 4 weeks
Women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of infant feeding method. The scale consists of 17 items on a 5-point Likert scale ranging from (strongly disagree) to (strongly agree). While 9 items in the scale are positive about breastfeeding, 8 items contain positive statements about formula feeding. Formula feeding items are reverse scored. The total attitude score ranged from 17 points (reflecting a positive attitude towards bottle feeding) to 85 points (reflecting a positive attitude towards breastfeeding). Cronbach Alpha internal consistency coefficient was 0.71 and the scale was found to be reliable.
0,2 and 4 weeks

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.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zehra Bicav, Saglık Bilimleri University
  • Principal Investigator: Filiz Ünal Toprak, PhD, Saglık Bilimleri University
  • Principal Investigator: Ceren Ceyda İşbuğa, Ankara Etlik City Hospital

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 (Actual)

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.
July 11, 2024

Primary Completion (Actual)

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.
September 11, 2024

Study Completion (Actual)

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.
September 15, 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).
July 25, 2024

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.
July 25, 2024

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.
July 30, 2024

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 25, 2024

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.
September 23, 2024

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.
September 1, 2024

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.
  • SBU-EBE-ZB-02

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

product manufactured in and exported from the U.S.

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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