Integrated Sensory Supported Virtual Reality and Gamified Digital Breastfeeding Education

December 7, 2024 updated by: ipek turhan

Effects of Integrative Sensory-Supported Virtual Reality and Gamified Digital Breastfeeding Education on Mothers' Breastfeeding Success, Self-Efficacy and Adaptation

Breastfeeding is the most ideal form of nutrition that concerns the health of mother and baby. The World Health Organization (WHO) recommends that breastfeeding should be started within the first hour after birth. Although breastfeeding has many benefits, research shows that breastfeeding rates are not at the desired level. Breastfeeding self-efficacy, success and adaptation become important to increase breastfeeding rates. In order to provide these components related to breastfeeding, breastfeeding education must be given starting from prenatal period. Education methods have taken different forms in line with the developing technology and the needs of the generation. WHO states that information and communication technology is an opportunity to support breastfeeding. Virtual reality and online learning applications also positively affect learning. New teaching methods, which are increasingly used today, make learning easier and can be used easily in virtual environments. Providing learning by doing in a realistic environment is important for successful breastfeeding and gaining breastfeeding skills and competence. In order to gain breastfeeding skills, the mother can experience breastfeeding during pregnancy using virtual reality technology. While breastfeeding skills are gained through virtual reality, information about breastfeeding can be provided through gamified digital training. With the game, the student actively participates in education. Active participation of the student in gamification ensures that knowledge becomes permanent. It is thought that the effect of the integrative sense can be used to facilitate postpartum remembering of these trainings.

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

Breastfeeding is the key to sustainable development. The second and third goals of the Sustainable Development Goals, a strategy plan to increase the development levels of countries by 2030 at the United Nations (UN) Sustainable Development Summit, are directly related to breastfeeding. The second of the Sustainable Development Goals is "Eradicate Hunger", while the third article directly related to breastfeeding is "Healthy Individuals". Breastfeeding is the only practice that will prevent hunger and malnutrition in the newborn and infancy period. Increasing breastfeeding can make positive contributions to the health of newborns, infants and children . Breastfeeding is the most ideal form of nutrition regarding the health of mothers and infants. The World Health Organization (WHO) recommends that breastfeeding should be initiated within the first hour after birth . Although breastfeeding has many benefits, studies show that breastfeeding rates are not at the desired level. The UNICEF 2019 report states that breastfeeding within the first hour following birth is 43%, and exclusive breastfeeding for the first six months is 41% . The Turkey Demographic and Health Survey 2018 breastfeeding and breastfeeding data show that 98% of children born in the last two years in Turkey were breastfed for any period of time. The percentage of breastfeeding within the first hour after birth is 71. Breastfeeding results are not at the targeted level due to the mother's attitude, lack of knowledge, incorrect breastfeeding methods, breast problems such as breast fullness, breast abscess, nipple pain and mastitis. Educating and supporting women about breastfeeding is very important in terms of increasing breastfeeding rates . For this reason, breastfeeding education should be started before birth and postpartum problems should be detected and resolved early. Receiving breastfeeding education positively affects breastfeeding success. WHO states that information communication technology is an opportunity to support breastfeeding. With the developing technology in recent years, mobile applications and the internet have become a source of health information. The development of mobile health technology increases patients' health knowledge and awareness and reduces the workload in the health field . It is seen that traditional methods cannot be successful in education due to reasons such as the increasing population, the distance of health institutions, and the inability of health workers and patients to spare time for health education. However, web-based training has advantages such as using visual and auditory methods together, updating the training content, not requiring transportation to the hospital, reaching different people simultaneously, reducing workload and costs . With developing technology, breastfeeding training has begun to be provided with technology-based methods. Since the learner is usually in a passive role in traditional training, critical thinking, problem-solving skills and the sense of living in the moment may not develop . Although the level of knowledge and learning is higher in breastfeeding training where visual materials are used compared to plain narration, breastfeeding skills cannot be developed and competence cannot be achieved . However, new teaching methods, which are increasingly used today, make learning easier and can be easily used in virtual environments. At the same time, virtual reality and online learning applications also positively affect learning . Recently, gamification has been used in online learning trainings to make trainings more interesting. Gamification is the process of presenting information by turning it into a game. Gamified teaching makes the learning process more attractive and increases motivation. With the game, the student actively participates in the training. The active participation of the student in gamification ensures that the knowledge becomes permanent. Studies have shown that web-based trainings increase breastfeeding self-efficacy and that continuing with breastfeeding support is also useful and up-to-date. Web-based trainings are interesting and effective compared to formal education. Combining these trainings with gamification will increase motivation and permanence of knowledge. However, breastfeeding is a psychomotor skill . Evidence-based guidelines recommend practical trainings to support breastfeeding . Learning by doing in a realistic environment

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.
105

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, Turkey, 38000
        • Kayseri City Hospital
        • Sub-Investigator:
          • Mürüvvet Başer, prof.dr
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Özlem Kaplan, Dr
        • Sub-Investigator:
          • Özlem Ülkü Bulut, Dr
        • Sub-Investigator:
          • Hüseyin Aksoy, Ast. Prof
        • Sub-Investigator:
          • Ali Saz, Dr

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:

  • literate,
  • healthy (no systemic/chronic disease, diagnosed psychiatric or neurological disease, no risky pregnancies, etc.)
  • primiparous pregnant women with singleton pregnancies,
  • planning to breastfeed,
  • having an internet-connected smart phone/tablet/computer and being able to use it actively,
  • competent enough to play games and having no problems with their hands, no breast problems that would make breastfeeding difficult (indentation, missing nipple, sore nipple, etc.),
  • no vision, hearing or communication problems,
  • pregnant women who are not allergic to lemon or lemon oil

Exclusion Criteria:

  • the occurrence of a situation that prevents sucking
  • the baby is not healthy

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: Treatment
  • 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.
Other: intervention group 1
Receiving breastfeeding skills training and gamified digital foundation training with virtual reality.
Other: virtual reality and digital education
Breastfeeding education through virtual reality and digital education
Other: intervention group 2
With virtual reality breastfeeding skills training, gamified digital-based breastfeeding training will be provided, and in addition, there will be a lemon oil scent in the environment during virtual reality breastfeeding skills training and in the postpartum period.
Other: virtual reality and digital education
Breastfeeding education through virtual reality and digital education
Other: virtual reality and digital education and lemon scent
virtual reality and digital education and lemon scent inhalation
No Intervention: control group
No training or intervention will be applied and will receive the hospital's standard treatment, care and education.

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 Self-Efficacy Scale
Time Frame: first day postpartum and thirtieth day postpartum
The Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, in 2003, Dennis reduced the scale to 14 items and developed the Breastfeeding Self-Efficacy Scale Short Form. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short Form was conducted by Aluş Tokat and Okumuş (2010). This scale evaluates how competent mothers feel about breastfeeding. The 14-item scale includes a 5-point Likert-type assessment consisting of the options Not at all sure (1), Not very sure (2), Sometimes sure (3), Sure (4) and Very sure (5). The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score obtained from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied in both the antenatal and postnatal periods. The difference between the antenatal form and the postnatal form of the scale is the use of the expression "future tense" in the scale items.
first day postpartum and thirtieth day postpartum
LATCH Diagnostic Scale
Time Frame: first day postpartum
The LATCH Breastfeeding Assessment Tool was created in 1986 by resembling the APGAR scoring system in terms of scoring method. The scale was developed to objectively diagnose breastfeeding, identify breastfeeding problems, plan training, create a common language among healthcare professionals, and be used in research. The scale, which is quick and easy to evaluate, consists of five evaluation criteria. Each item is evaluated between 0 and 2 points. The total possible score is 10 and there is no cut-off point. As the score increases, it is understood that breastfeeding success is high. .
first day postpartum
Breastfeeding Adaptation Scale
Time Frame: first day postpartum and thirtieth day postpartum
The Breastfeeding Adaptation Scale was developed by Sun Hee Kim (2009). The Turkish validity and reliability were made by Dinçel and Özdilek (2021). Scale items were rated with a 5-point Likert (1 point: Strongly disagree, 2 points: Disagree, 3 points: Undecided, 4 points: Agree, 5 points: Strongly agree). The items in the 6th sub-dimension of the scale, "breastfeeding discomfort", are reverse coded. The score that can be obtained from the scale varies between 27-135. An increase in the total score indicates a high level of breastfeeding adaptation.
first day postpartum and thirtieth day postpartum

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.
ipek turhan

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 (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.
December 1, 2024

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.
November 1, 2025

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.
November 1, 2026

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 3, 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.
December 3, 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.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 12, 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.
December 7, 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.
December 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.
  • ErciyesU-SBF-IT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since the study has not started, it is not planned to be shared at the moment for the confidentiality of the study idea.

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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