Virtual Reality in Labor and Delivery for Reduction in Pain
2021年10月29日 更新者：Kimberly Gregory、Cedars-Sinai Medical Center
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Female
- >18 years old
- Pregnant with term gestation
- Nullipara
- 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
Exclusion Criteria:
- Parous
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Latent-Control
Patients in the latent phase of labor who will receive no intervention.
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实验性的：Latent-Virtual Reality (VR)
Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
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For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes.
Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.).
The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduction in Pain
大体时间：4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
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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.
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4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With a Need for Intravenous Pain Medication
大体时间：The total duration of the intervention (30 minutes)
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IV pain medication during the intervention (yes/no)
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The total duration of the intervention (30 minutes)
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Need for Epidural During the Intervention
大体时间：The total duration of the intervention (30 minutes)
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Number of participants with need for an epidural during the intervention
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The total duration of the intervention (30 minutes)
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Childbirth Self-Efficacy Inventory
大体时间：30 minutes
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The Childbirth Self-Efficacy Inventory (CSEI) is a measure of how well a patient anticipates being able to perform certain tasks in labor such as relaxing their body, keeping calm, or not thinking about the pain.
The investigators will ask to what extend they feel virtual reality would be able to influence their ability to do these things.
A fifteen-question scale reflecting degree of control where 1 is least control and 5 is most control per item.
Minimum score 15 reflecting least total control; maximum score 75 reflecting maximal control.
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30 minutes
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Number of Participants With a Need for Epidural During the Labor
大体时间：The total duration of the patient's labor (average 24 hours)
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Epidural use during labor (yes/no)
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The total duration of the patient's labor (average 24 hours)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
- Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月1日
初级完成 (实际的)
2019年2月19日
研究完成 (实际的)
2019年2月19日
研究注册日期
首次提交
2018年1月16日
首先提交符合 QC 标准的
2018年2月12日
首次发布 (实际的)
2018年2月19日
研究记录更新
最后更新发布 (实际的)
2021年11月26日
上次提交的符合 QC 标准的更新
2021年10月29日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Virtual Reality device的临床试验
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Southern Methodist UniversityKing's College London完全的
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IRCCS Eugenio Medea招聘中
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona招聘中
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Hospital Universitari Vall d'Hebron Research Institute主动，不招人