Breast Milk Expression With Virtual Reality

Virtual Reality Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164223
• Other study ID #: Akdenizuniversityy
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Akdeniz University
• Contact: Meltem OZKAYA
• Phone: +90 539 654 44 46
• Email: meltemozkaya66[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Having given birth before the 37th week of pregnancy

2. The baby is in the neonatal intensive care unit

3. Being on postpartum day 0

4. Being milked

5. Being a citizen of the Republic of Türkiye,

Exclusion Criteria:

1. Loss of the newborn

2. Leaving the newborn from the intensive care unit before the second postpartum day

3. The mother has a condition that prevents breastfeeding

4. The mother states that she feels discomfort (nausea, disorientation, etc.) when the application begins.

5. Those with vision and hearing problems

6. Those with a psychiatric diagnosis

7. Those who are not capable of using virtual reality glasses

8. Those who watched the video while only one breast was being pumped (those who watched only 15 minutes)

Related Conditions & MeSH terms

• Breast Milk Expression
• Virtual Reality

Intervention

Device:
• VR Baby Pump
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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postpartum 2nd day
Primary	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	Postpartum 2nd day
Primary	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	Postpartum 2nd day