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

January 2, 2026 updated by: Suzi Özdemir, Kocaeli University

The Impact of Virtual Reality-Assisted Relaxation on Breastfeeding Self-Efficacy and Breast Milk Production in Mothers of Premature Infants: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41001
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Breast Milk Volume
Time Frame: Daily for 3 consecutive days.
The total amount of breast milk expressed manually during the study session.
Daily for 3 consecutive days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Self-Efficacy Scale Score
Time Frame: At the end of the 3rd day of the intervention.
Maternal confidence in breastfeeding as measured by the "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants" (BSES-SF-PI). The scale consists of 20 items. Total scores range from 20 to 100, where higher scores indicate higher levels of breastfeeding self-efficacy.
At the end of the 3rd day of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Suzi-04

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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