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Completed

NCT Number: NCT07336186

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-Based Relaxation

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.

Primary outcomes

  1. Daily Breast Milk Volume

    Time frame: Daily for 3 consecutive days.

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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