Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pain and Anxiety
研究概览
简要总结
The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual Reality (VR) during labor. We will also explore whether VR distraction is helpful for reducing subjective pain during labor, even if this pain is severe or excruciating. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.
详细描述
This study used an over the counter consumer product to create a virtual reality experience so that we could assess whether there was a decrease in perception of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any woman giving birth for the first time at or after 32 weeks
- •Low risk pregnancy without obstetric complications
- •In first stage of labor for vaginal delivery
- •Desires non-pharmacologic alternative for pain control
排除标准
- •Younger than 18 or older than 45 years of age
- •Presence of fetal or placental anomaly
- •High risk pregnancy or anesthetic concerns (BMI>40, difficult airway, hemorrhage, nonreassuring FHR, malpresentation)
- •Current use of pharmacologic analgesia including neuraxial anesthesia
- •Not capable of answering study measures using numeric rating scale
- •Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
- •Any form of contact precautions
- •Severe hearing or vision deficits
- •Susceptibility to motion sickness
- •Seizure history
- •History of psychiatric disorder, chronic pain, migraines, or addiction
- •Delirium, psychosis, any form of developmental delay, or Organic Brain Disorder
- •Requiring an interpreter for communication
研究组 & 干预措施
Standard Care
For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions. Afterwards they will answer pain and anxiety questionnaires.
Virtual Reality
For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions while using immersive Virtual Reality.Afterwards they will answer pain and anxiety questionnaires.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Pain and Anxiety
时间窗: one time for the duration of one minute after 10 minutes of contractions using Virtual Reality
Pain is measured one time after 10 minutes of contractions with Virtual Reality, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale.
Satisfaction
时间窗: one time for the duration of one minute after using Virtual Reality
Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire.
次要结局
未报告次要终点
研究者
Melissa Bauer
Assistant Professor
University of Michigan