The Effect of Virtual Reality-Based Relaxation on Breast Milk Volume and Breastfeeding Self-Efficacy in Mothers of Preterm Infants

NCT ID: NCT07336186

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-10-01

Brief Summary

This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. The study compares their milk volume and self-efficacy scores to a control group receiving standard care.

Detailed Description

The purpose of this study is to evaluate the impact of a virtual reality (VR) relaxation intervention on breast milk production and breastfeeding confidence in mothers of premature infants.

Methodology:

• The study followed a randomized controlled design with two parallel groups.
• A total of 44 mothers whose infants were hospitalized in a Level II Neonatal Intensive Care Unit were enrolled.
• Participants were randomly assigned to either the intervention group or the control group.

Intervention and Procedures:

• Intervention Group: Participants used a VR headset to watch a 10-minute video featuring nature landscapes accompanied by classical music. Following the video, the researcher performed manual milk expression for at least 20 minutes.
• Control Group: Participants sat in the same breastfeeding room but did not use the VR headset. They received the same manual milk expression procedure by the same researcher.
• The procedure was conducted once daily for three consecutive days for both groups.
• To maintain stability in milk fat content, all sessions took place between 12:00 and 14:00.

Data Collection:

• Daily milk volume was measured in milliliters using sterile containers or injectors.
• Breastfeeding self-efficacy was assessed at the end of the third day using the "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants".
• Demographic information was collected at the beginning of the study using a personal information form.

Conditions

Lactation; Breastfeeding; Premature Birth; Maternal Stress; Self-Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

Mothers in this group used a virtual reality (VR) headset before the milk expression process. They watched a 10-minute relaxation video consisting of nature scenes (forests, waterfalls) accompanied by classical music. After the session, the researcher performed manual milk expression for at least 20 minutes. This procedure was repeated once daily for three days.

Group Type: EXPERIMENTAL

Virtual Reality-Based Relaxation

Intervention Type: BEHAVIORAL

A 10-minute immersive VR experience featuring calming nature landscapes and classical music designed to reduce stress and promote let-down reflex before milk expression.

Control Group

Mothers in this group received standard care. They sat in the same breastfeeding room for 10 minutes but did not use the VR headset or any other relaxation intervention. Following this period, the researcher performed manual milk expression for at least 20 minutes using the same technique as the experimental group. This procedure was repeated once daily for three days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality-Based Relaxation

A 10-minute immersive VR experience featuring calming nature landscapes and classical music designed to reduce stress and promote let-down reflex before milk expression.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Mothers who have given birth to a single infant between 32 and 35 weeks of gestation.
• Mothers whose infants are hospitalized in the Neonatal Intensive Care Unit (NICU).
• Mothers who have delivered via Cesarean section.
• First-time mothers (Primiparous).
• Mothers who are willing to provide breast milk and participate in the study.
• Mothers whose infants are not yet able to breastfeed directly and require milk expression.

Exclusion Criteria

• Mothers with any systemic or psychiatric diseases.
• Mothers with obstetric complications.
• Mothers who have a history of using addictive substances.
• Mothers who use medications or herbal products to increase breast milk (galactagogues).
• Mothers with hearing or vision impairments that would prevent the use of a VR headset.
• Mothers whose infants have congenital anomalies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Suzi Özdemir

Assistant Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Kocaeli, İzmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Suzi-04

Identifier Type: -

Identifier Source: org_study_id