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Breast Milk Expression With Virtual Reality

NCT ID: NCT06164223

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Virtual Reality Breast Milk Expression

Keywords

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Transition to motherhood Preterm birth Breast milk expression experience VR Baby Pump

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

Group to which VR Baby Pump will be applied

Group Type EXPERIMENTAL

VR Baby Pump

Intervention Type DEVICE

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.

Control

An intervention will not be applied.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Ozkaya

Research asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oznur Korukcu

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Akdeniz University

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Meltem OZKAYA

Role: CONTACT

Phone: +90 539 654 44 46

Email: [email protected]

Oznur KORUKCU

Role: CONTACT

Phone: +90 505 385 67 76

Email: [email protected]

Facility Contacts

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Meltem Ozkaya

Role: primary

Oznur Korukcu

Role: backup

Other Identifiers

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Akdenizuniversityy

Identifier Type: -

Identifier Source: org_study_id