Breast FeedingNCT06722053
Integrated Sensory Supported Virtual Reality and Gamified Digital Breastfeeding Education
A study testing virtual reality and digital education and virtual reality and digital education and lemon scent in people with Breast Feeding, run by ipek turhan at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- virtual reality and digital education and virtual reality and digital education and lemon scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- the occurrence of a situation that prevents sucking
- the baby is not healthy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kayseri, 38000
ipek turhan, master, 5535443381, ipekturhan38@gmail.com
Mürüvvet Başer, prof.dr, 5333805614, mbaser@erciyes.edu.tr
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Feeding
- Being tested
- virtual reality and digital education, virtual reality and digital education and lemon scent
- Keywords
- breasfeeding, virtual reality, gamification
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality and digital educationOther
Breastfeeding education through virtual reality and digital education
virtual reality and digital education and lemon scentOther
virtual reality and digital education and lemon scent inhalation
| Study group | Role | What they receive |
|---|---|---|
| intervention group 1 | Other | Receiving breastfeeding skills training and gamified digital foundation training with virtual reality. Receives: Other: virtual reality and digital education |
| intervention group 2 | Other | 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. Receives: Other: virtual reality and digital education; Other: virtual reality and digital education and lemon scent |
| control group | No intervention | No training or intervention will be applied and will receive the hospital's standard treatment, care and education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale
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.
Measured: first day postpartum and thirtieth day postpartum
LATCH Diagnostic Scale
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. .
Measured: first day postpartum
Breastfeeding Adaptation Scale
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.
Measured: first day postpartum and thirtieth day postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two intervention groups and one control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ipek turhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ipek turhan, TC Erciyes University
- Investigators
- ipek turhan, master, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722053
- Sponsor's protocol ID
- ErciyesU-SBF-IT-02
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the study has not started, it is not planned to be shared at the moment for the confidentiality of the study idea.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrative Sensory-Supported Virtual Reality and Gamified Digital Breastfeeding Education on Mothers' Breastfeeding Success, Self-Efficacy and Adaptation
- ClinicalTrials.gov ID
- NCT06722053
- Acronym / sponsor ID
- ErciyesU-SBF-IT-02
- Conditions
- Breast Feeding
- Keywords
- breasfeeding, virtual reality, gamification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- ipek turhanUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There are two intervention groups and one control group.
| Arm | Type | Receives |
|---|---|---|
| intervention group 1 | Other | Other: virtual reality and digital educationReceiving breastfeeding skills training and gamified digital foundation training with virtual reality. |
| intervention group 2 | Other | Other: virtual reality and digital education, Other: virtual reality and digital education and lemon scentWith 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. |
| control group | No intervention | –No training or intervention will be applied and will receive the hospital's standard treatment, care and education. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- the occurrence of a situation that prevents sucking
- the baby is not healthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality and digital educationBreastfeeding education through virtual reality and digital education | Other | intervention group 1, intervention group 2 |
| virtual reality and digital education and lemon scentvirtual reality and digital education and lemon scent inhalation | Other | intervention group 2 |
Primary outcome
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.
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. .
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No. Since the study has not started, it is not planned to be shared at the moment for the confidentiality of the study idea.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ipek turhan, master principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and digital education and virtual reality and digital education and lemon scent in people with Breast Feeding, run by ipek turhan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ipek turhan, master (+90 5535443381, ipekturhan38@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy Scale (time frame: first day postpartum and thirtieth day postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.