NCT07336186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

Virtual RealityRelaxation techniquesBreast milk volumeBreastfeeding self-efficacy

Outcome Measures

Primary Outcomes (1)

  • Daily Breast Milk Volume

    The total amount of breast milk expressed manually during the study session.

    Daily for 3 consecutive days.

Secondary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale Score

    At the end of the 3rd day of the intervention.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingPremature Birth

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an experimental group receiving VR-based relaxation or a control group receiving standard care. Both groups were followed simultaneously for a period of three days to compare outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations