Breast Milk Expression With Virtual Reality

NCT06164223 | Unknown

• 1 other identifier: Akdenizuniversityy
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Virtual Reality; Breast Milk Expression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

Group to which VR Baby Pump will be applied

Device: VR Baby Pump

Control

NO INTERVENTION

An intervention will not be applied.

Interventions

VR Baby Pump 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Muğla, 05396544446, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression; Premature Birth

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Oznur Korukcu

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meltem OZKAYA

CONTACT

+90 539 654 44 46; meltemozkaya66@gmail.com

Oznur KORUKCU

CONTACT

+90 505 385 67 76; oznurkorukcu@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research asistant

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: December 11, 2023
• Study Start: November 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)