Breastfeeding Education Prepared with Virtual Reality Technology

February 18, 2025 updated by: ipek turhan, TC Erciyes University

The Effect of Antenatal Breastfeeding Education Prepared with Virtual Reality Technology on Breastfeeding Self-Efficacy and Breastfeeding Success of Primiparous Mothers

The breastfeeding software developed with the primiparous study was transferred to virtual reality glasses. This study will be applied to pregnant women and its effect on breastfeeding success and breastfeeding self-efficacy will be investigated.

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

The goal of this clinical trial is to To learn The Effect Of Pre-Natal Breastfeeding Education Prepared Wıth Virtual Reality Technology On The Breastfeeding Self-Efficiency And Breastfeeding Success Of Primiparous Mothers in The study will be delivered to 60 healthy primiparous pregnant women.The breastfeeding software developed with the primary study was transferred to virtual reality glasses. It will also be implemented in this study. The main questions it aims to answer are:

  • Prenatal breastfeeding education prepared with virtual reality technology positively affects the breastfeeding self-efficacy of primiparous mothers.
  • Prenatal breastfeeding education prepared with virtual reality technology positively affects the breastfeeding of primiparous mothers.

Participants will Pregnant women in the intervention group will be given breastfeeding training prepared with virtual reality technology and will fill out questionnaires and scales will be filled in on the first and seventh days after birth. Questionnaires will be filled in by pregnant women in the control group, and the scales will be filled out only on the first and seventh days.

Researchers will compare breastfeeding education given with virtual reality glasses with the control group to see whether it has an effect on breastfeeding success and breastfeeding self-efficacy.

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.
59

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

Study Locations

  • Turkey
    • Kayseri
      • Kayseri̇, Kayseri, Turkey, 38000
        • Ipek Turhan

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:

  • Between the ages of 18 and 35
  • literate,
  • Pregnant women who are at 37 weeks of gestation and above,
  • Those with healthy pregnancies (singleton pregnancy, no systemic/chronic disease, etc.) -Primiparous pregnant women-
  • Vaginal birth planned,
  • planning to breastfeed,
  • Those who do not have any problems with their breasts that would make breastfeeding difficult (collapsed, missing tip, wound on the nipple, etc.),
  • Pregnant women who do not have vision, hearing or communication problems
  • Pregnant women who do not have any problems will be included in the study.

Exclusion Criteria:

  • Occurrence of a situation that prevents sucking
  • Baby with congenital anomalies

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: 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: intervention group
The effect of breastfeeding education given with virtual reality glasses on breastfeeding success and breastfeeding self-efficacy will be evaluated. The education given during pregnancy will be evaluated on the first and seventh days after birth.
Other: virtual reality glasses
The breastfeeding software developed will be applied in this group.
No Intervention: control group
Breastfeeding success and breastfeeding self-efficacy of women included in this group during pregnancy will be evaluated on the first and seventh days after birth.

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
breastfeeding success
Time Frame: 4-5 week
LACTH BREASTFEEDING ASSESSMENT SCALE This measurement tool consists of five evaluation criteria and is a combination of the first letters of the English equivalents of these criteria. Each item is evaluated between 0 and 2 points. The total score that can be obtained from the measurement tool is 10. The measurement tool has no cutoff point. It is understood that the higher the LATCH score, the higher the breastfeeding success.
4-5 week
breastfeeding self-efficacy
Time Frame: 4-5 week
breastfeeding self-efficacy scale The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short Form was conducted by Aluş Tokat and Okumuş in 2009 . This scale evaluates how competent mothers feel regarding breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of the options: Not at all sure , Very not sure , Sometimes sure , Sure and Very sure . The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.
4-5 week

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.
TC Erciyes University

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: ipek turhan, master, Kayseri 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.
November 1, 2023

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.
May 1, 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.
January 1, 2025

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 21, 2023

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.
January 19, 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.
January 29, 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.
March 25, 2025

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.
February 18, 2025

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.
February 1, 2025

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.
  • ErciyesU-SBF-IT-01

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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