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临床试验/NCT07336186
NCT07336186已完成不适用

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

Kocaeli University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Daily Breast Milk Volume

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Virtual Reality-Based Relaxation (Behavioral)

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.

结局指标

主要结局

Daily Breast Milk Volume

时间窗: Daily for 3 consecutive days.

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

次要结局

  • Breastfeeding Self-Efficacy Scale Score(At the end of the 3rd day of the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzi Özdemir

Assistant Professor, PhD

Kocaeli University

研究点 (2)

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