Virtual RealityNCT06164223
Breast Milk Expression With Virtual Reality
A study testing VR Baby Pump in people with Virtual Reality and Breast Milk Expression, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's breast milk expression experience, transition process, and milk amount. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Breast Milk Expression
- What is being tested?
- VR Baby Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 31 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having given birth before the 37th week of pregnancy
- The baby is in the neonatal intensive care unit
- Being on postpartum day 0
- Being milked
- Being a citizen of the Republic of Türkiye,
Who cannot join
- Loss of the newborn
- Leaving the newborn from the intensive care unit before the second postpartum day
- The mother has a condition that prevents breastfeeding
- The mother states that she feels discomfort (nausea, disorientation, etc.) when the application begins.
- Those with vision and hearing problems
- Those with a psychiatric diagnosis
- Those who are not capable of using virtual reality glasses
- Those who watched the video while only one breast was being pumped (those who watched only 15 minutes)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University
Muğla, 05396544446
Meltem Ozkaya, +90 5396544446, meltemozkaya66@gmail.com
Oznur Korukcu, +90 5053856, oznurkorukcu@akdeniz.edu.tr
About this study
Official title: The Effect of the "VR Baby-Pump" Application Applied to Mothers Who Gave Birth Preterm on Their Breast Milk Expression Experience, Transition Process, and Milk Quantity: Randomized Controlled Study
The study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's breast milk expression experience, transition process, and milk amount. In the study, the effectiveness of the VRBaby-Pump application will be evaluated based on evidence using the Breastfeeding Experience and Transition to Motherhood Scale. Stratified and block randomization methods will be used in the study. The study data will be collected from mothers who gave birth preterm at the Perinatology clinic of Health Sciences University (SBU) Antalya Training and Research Hospital between September and December 2023.
Read the detailed description
Preterm labor is defined as births that occur before the 37th week of pregnancy is completed. While every 15 million babies worldwide are born prematurely, it is stated that 15 out of every 100 babies are premature in our country. Breast milk is the best source of nutrition for all newborn babies to complete their growth and development, and it is recommended that they be fed only with breast milk for the first six months; On the other hand, the rate of premature babies being exclusively breastfed for the first six months is quite low. It is perceived as an obligatory duty for mothers to not have their baby with them after birth, and to see a milking machine at their breast instead of their baby. Therefore, the transition to motherhood, the experiences they experience after birth, and the amount of milk the baby receives are affected. Nurses should support the mother who has given birth preterm to start and continue the lactation process, ensuring that the baby is fed with breast milk and has a positive experience with the transition to healthy motherhood. With the introduction of virtual reality applications into our lives in recent years, there are many areas of use in the field of health. Since it is not possible for mothers who give birth preterm to move from the hospital to the home environment with their babies immediately after birth, it is thought that by preparing a virtual baby and baby room, mothers will have good experiences during the lactation process and a healthy transition to motherhood, which will also lead to an increase in the amount of milk.
The study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's milking experience, transition process, and milk amount. In the study, the effectiveness of the VRBaby-Pump application will be evaluated based on evidence using the Breastfeeding Experience and Transition to Motherhood Scale. Stratified and block randomization methods will be used in the study. The study data will be collected from mothers who gave birth preterm at the Perinatology Clinic of Health Sciences University (SBU) Antalya Training and Research Hospital between September and December 2023. This study will be the first nursing study on this subject in both national and international literature. As a result of this study, the milking experience of mothers who gave birth preterm, the transition to motherhood, and the amount of milk will be determined, and a new milk-selling virtual reality program will be offered to mothers who give birth preterm.
- Conditions
- Virtual Reality, Breast Milk Expression
- Being tested
- VR Baby Pump
- Keywords
- Transition to motherhood, Preterm birth, Breast milk expression experience, VR Baby Pump
- Medical subject headings
- Breast Milk Expression, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Baby PumpDevice
VRBaby-Pump application is a video application specially prepared with virtual reality glasses and a milking pump placed inside a toy doll. In the video content, the mother is breastfeeding her baby on an armchair in the baby room prepared for a newborn baby.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Group to which VR Baby Pump will be applied Receives: Device: VR Baby Pump |
| Control | No intervention | An intervention will not be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the transition process to motherhood of mothers who gave birth preterm
transition to positive motherhood, It will use the Transition of Motherhood Scale to do an evaluation
Measured: Postpartum 2nd day
Evaluation of the breast milk expression experience of mothers who gave birth preterm
positive breast milk expression experience, It will use the Breast Milk Expression Experience Scale to do an evaluation
Measured: Postpartum 2nd day
Evaluation of milk quantity of mothers who gave birth preterm
high amount of breast milk, It will use the Daily Breast Milk Form to do an evaluation
Measured: Postpartum 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two Groups with parallel properties. The first group is the experimental group using virtual reality glasses. The second group is the control group without intervention.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Ozkaya, Akdeniz University
- Investigators
- Oznur Korukcu, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164223
- Sponsor's protocol ID
- Akdenizuniversityy
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the "VR Baby-Pump" Application Applied to Mothers Who Gave Birth Preterm on Their Breast Milk Expression Experience, Transition Process, and Milk Quantity: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06164223
- Acronym / sponsor ID
- Akdenizuniversityy
- Conditions
- Virtual Reality, Breast Milk Expression
- Keywords
- Transition to motherhood, Preterm birth, Breast milk expression experience, VR Baby Pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Dec 2023 (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 study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's breast milk expression experience, transition process, and milk amount. In the study, the effectiveness of the VRBaby-Pump application will be evaluated based on evidence using the Breastfeeding Experience and Transition to Motherhood Scale. Stratified and block randomization methods will be used in the study. The study data will be collected from mothers who gave birth preterm at the Perinatology clinic of Health Sciences University (SBU) Antalya Training and Research Hospital between September and December 2023.
Detailed description
Preterm labor is defined as births that occur before the 37th week of pregnancy is completed. While every 15 million babies worldwide are born prematurely, it is stated that 15 out of every 100 babies are premature in our country. Breast milk is the best source of nutrition for all newborn babies to complete their growth and development, and it is recommended that they be fed only with breast milk for the first six months; On the other hand, the rate of premature babies being exclusively breastfed for the first six months is quite low. It is perceived as an obligatory duty for mothers to not have their baby with them after birth, and to see a milking machine at their breast instead of their baby. Therefore, the transition to motherhood, the experiences they experience after birth, and the amount of milk the baby receives are affected. Nurses should support the mother who has given birth preterm to start and continue the lactation process, ensuring that the baby is fed with breast milk and has a positive experience with the transition to healthy motherhood. With the introduction of virtual reality applications into our lives in recent years, there are many areas of use in the field of health. Since it is not possible for mothers who give birth preterm to move from the hospital to the home environment with their babies immediately after birth, it is thought that by preparing a virtual baby and baby room, mothers will have good experiences during the lactation process and a healthy transition to motherhood, which will also lead to an increase in the amount of milk.
The study is a randomized controlled study planned to determine the effect of the VRBaby-Pump application applied to mothers who gave birth preterm, on the mother's milking experience, transition process, and milk amount. In the study, the effectiveness of the VRBaby-Pump application will be evaluated based on evidence using the Breastfeeding Experience and Transition to Motherhood Scale. Stratified and block randomization methods will be used in the study. The study data will be collected from mothers who gave birth preterm at the Perinatology Clinic of Health Sciences University (SBU) Antalya Training and Research Hospital between September and December 2023. This study will be the first nursing study on this subject in both national and international literature. As a result of this study, the milking experience of mothers who gave birth preterm, the transition to motherhood, and the amount of milk will be determined, and a new milk-selling virtual reality program will be offered to mothers who give birth preterm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two Groups with parallel properties. The first group is the experimental group using virtual reality glasses. The second group is the control group without intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: VR Baby PumpGroup to which VR Baby Pump will be applied |
| Control | No intervention | –An intervention will not be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having given birth before the 37th week of pregnancy
- The baby is in the neonatal intensive care unit
- Being on postpartum day 0
- Being milked
- Being a citizen of the Republic of Türkiye,
Key exclusion criteria (8 listed)
- Loss of the newborn
- Leaving the newborn from the intensive care unit before the second postpartum day
- The mother has a condition that prevents breastfeeding
- The mother states that she feels discomfort (nausea, disorientation, etc.) when the application begins.
- Those with vision and hearing problems
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 |
|---|---|---|
| VR Baby PumpVRBaby-Pump application is a video application specially prepared with virtual reality glasses and a milking pump placed inside a toy doll. In the video content, the mother is breastfeeding her baby on an armchair in the baby room prepared for a newborn baby. | Device | Experimental |
Primary outcome
Evaluation of the transition process to motherhood of mothers who gave birth preterm
Time frame: Postpartum 2nd day
transition to positive motherhood, It will use the Transition of Motherhood Scale to do an evaluation
Evaluation of the breast milk expression experience of mothers who gave birth preterm
Time frame: Postpartum 2nd day
positive breast milk expression experience, It will use the Breast Milk Expression Experience Scale to do an evaluation
Evaluation of milk quantity of mothers who gave birth preterm
Time frame: Postpartum 2nd day
high amount of breast milk, It will use the Daily Breast Milk Form to do an evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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.
Oznur Korukcu principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Baby Pump in people with Virtual Reality and Breast Milk Expression, run by Akdeniz 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meltem OZKAYA (+90 539 654 44 46, meltemozkaya66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the transition process to motherhood of mothers who gave birth preterm (time frame: Postpartum 2nd day). 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 11 Dec 2023.