Virtual Reality in Labor and Delivery for Reduction in Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction in Pain
研究概览
简要总结
The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.
详细描述
The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural.
The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are < 6 cm or > 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •>18 years old
- •Pregnant with term gestation
- •Pain due to contractions rated from 4-7
- •Contractions at least every 5 minutes x 30 minutes preceding
- •Pain scores obtained at least every 60 minutes
排除标准
- •Use of intravenous medications for pain relief prior to the intervention
- •Use of an epidural
- •Preterm gestation
- •Pain not due to contractions
- •Pain score of 3 or below or 8 or above
结局指标
主要结局
Reduction in Pain
时间窗: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Difference in pain scores pre-post intervention compared to control. The investigators will use the Visual Analog Scale (VAS) for Pain. The minimum pain is 1; the maximum is 10. Higher values represent more pain.
次要结局
- Number of Participants With a Need for Epidural During the Labor(The total duration of the patient's labor (average 24 hours))
- Number of Participants With a Need for Intravenous Pain Medication(The total duration of the intervention (30 minutes))
- Need for Epidural During the Intervention(The total duration of the intervention (30 minutes))
- Childbirth Self-Efficacy Inventory(30 minutes)
研究者
Kimberly Gregory
Professor
Cedars-Sinai Medical Center