Use of Virtual Reality in Active Labor
研究概览
详细说明
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely.
For all these reasons, it is not surprising the interest in offering women valid non-invasive and cheaper options to relieve them from pain. As of today many alternative techniques have been proposed, many of which have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas. Recently Frey et al. have experimented in a pilot study the application of this technique to women during labor, obtaining interesting results. The authors of this study point, in the discussion of the scientific paper, to the necessity of developing virtual reality experiences more specific to labor and suggest different implementations, such as specific instructions for women (changes of position, breathing techniques) greater comfort (it is worth noticing the use on our side of exclusively wireless devices) and the implementation of the device with biofeedback.
In addition to learning from these suggestions, we tried to imagine VR in a different way: firstly as complementary, not alternative to the role of the midwife personnel, who will play a central role in our experimental treatment enriching the virtual reality scenario with their instructions, presence and motivational feedback; secondly we tried to imagine VR as a guide through labor, more than a alienation and distraction tool.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Naples、意大利、80100
- Gabriele Saccone
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- singleton gestations;
- term pregnancy
- spontaneous labor
- diagnosis of active phase of labor;
- nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
Exclusion Criteria:
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- hipertensive disorders;
- fetal abnormalities;
- diabetes mellitus;
- intrauterine growth retardation;
- post-term pregnancy;
- multiple vaginal delivery;
- women with an altered state of consciousness, severely ill, mentally disabled;
- women with sight and/or hearing impairment;
- women at risk of epileptic seizures;
- women with predisposition to motion sickness;
- women under the age of 18 years or over the age of 45 years;
- Women who refuse to sign informed informed consent form.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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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实验性的:Virtual Reality (VR) devices
intervention group (VR).
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Virtual Reality (VR) devices.
Subjects receiving the experimental treatment will be given a VR headset, headphones and wristband and the Philips wireless fetal-maternal monitoring system, after the necessary preparation of the abdominal skin.
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无干预:control group
the standard of care (control group, no VR)
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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 |
---|---|---|
Subjective pain during the active phase
大体时间:"during the active phase of labor up to 10 cm"
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women pain using visual analogue scale (VAS)
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"during the active phase of labor up to 10 cm"
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
nausea
大体时间:during the active phase of labor (i.e. after 4-6 cm of dilatation)
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nausea referred by the patient and episodes of vomiting
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during the active phase of labor (i.e. after 4-6 cm of dilatation)
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anxiety
大体时间:during the active phase of labor (i.e. after 4-6 cm of dilatation)
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women axneity using visual analogue scale (VAS)
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during the active phase of labor (i.e. after 4-6 cm of dilatation)
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Incidence of episiotomy
大体时间:at the time of delivery
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Incidence of episiotomy
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at the time of delivery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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 (VR) devices的临床试验
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IRCCS Eugenio Medea招聘中