Breast FeedingNCT06229574
Breastfeeding Education Prepared With Virtual Reality Technology
A study testing virtual reality glasses in people with Breast Feeding, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. 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 glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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,
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- 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.
Who cannot join
- Occurrence of a situation that prevents sucking
- Baby with congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Feeding
- Being tested
- virtual reality glasses
- Keywords
- Breast Milk, Breast-feeding, Breastfeeding Education, Virtual Reality
- 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 glassesOther
The breastfeeding software developed will be applied in this group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Other: virtual reality glasses |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding success
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.
Measured: 4-5 week
breastfeeding self-efficacy
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.
Measured: 4-5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 Jan 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research will be conducted as an experimental single-blind study with a randomized control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ipek turhan, TC Erciyes University
- Investigators
- ipek turhan, master, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229574
- Sponsor's protocol ID
- ErciyesU-SBF-IT-01
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antenatal Breastfeeding Education Prepared With Virtual Reality Technology on Breastfeeding Self-Efficacy and Breastfeeding Success of Primiparous Mothers
- ClinicalTrials.gov ID
- NCT06229574
- Acronym / sponsor ID
- ErciyesU-SBF-IT-01
- Conditions
- Breast Feeding
- Keywords
- Breast Milk, Breast-feeding, Breastfeeding Education, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 29 Jan 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The research will be conducted as an experimental single-blind study with a randomized control group.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: virtual reality glassesThe 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (2 listed)
- Occurrence of a situation that prevents sucking
- Baby with congenital anomalies
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 glassesThe breastfeeding software developed will be applied in this group. | Other | intervention group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 glasses in people with Breast Feeding, run by TC Erciyes University 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 9 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: finished, as of the sponsor's last update on 20 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breastfeeding success (time frame: 4-5 week). The study lists 2 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 20 Feb 2025.