Breast Milk Expression With Virtual Reality

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Virtual Reality; Breast Milk Expression
• Intervention / Treatment: Device: VR Baby Pump

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 Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem OZKAYA; Phone Number: +90 539 654 44 46; Email: meltemozkaya66@gmail.com
• Study Contact Backup: Name: Oznur KORUKCU; Phone Number: +90 505 385 67 76; Email: oznurkorukcu@akdeniz.edu.tr

Study Locations

• Turkey
  • Muğla, Turkey, 05396544446
    • Akdeniz University
    • Contact: Meltem Ozkaya; Phone Number: +90 5396544446; Email: meltemozkaya66@gmail.com
    • Contact: Oznur Korukcu; Phone Number: +90 5053856; Email: oznurkorukcu@akdeniz.edu.tr
    • Principal Investigator: Oznur KORUKCU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Group to which VR Baby Pump will be applied	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.
No Intervention: Control; An intervention will not be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Oznur KORUKCU, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Preterm birth; Transition to motherhood; Breast milk expression experience; VR Baby Pump
• Other Study ID Numbers: Akdenizuniversityy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No