Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies (NHYP)
2021年10月18日 更新者：University Hospital, Strasbourg, France
Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.
Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.
the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.
The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.
研究概览
研究类型
介入性
注册 (预期的)
108
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。
学习联系方式
- 姓名：Anne Laudamy
- 电话号码：+33 3 88 11 66 88
- 邮箱：anne.laudamy@chru-strasbourg.fr
研究联系人备份
- 姓名：anatta Razafimanantsoa
- 电话号码：+ 33 3 88 11 54 14
- 邮箱：anatta.razafimanantsoa@chru-strasbourg.fr
学习地点
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Strabsourg、法国、67091
- 招聘中
- University Strasbourg Hospital
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接触：
- Raoul HERBRECHT, MD
- 邮箱：raoul.herbrecht@chru-strasbourg.fr
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接触：
- Caroline MAURER, Nurse
- 邮箱：caroline.maurer@chru-strasbourg.fr
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Minimum age :18 years
- Chemiotherapy- induced chronic neuropathies for at least 2 months with a DN4 score >4
- Failure of classic treatment used to relief neuropathic
- Having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability
- Without any planed chemiotherapy during the study
- Having signed a written informed consent.
- French efficient understanding
- With health insurance coverage
- availability during all the study
- With efficient contraception for women of childbearing age
Exclusion Criteria:
- No participation to another study at the same time
- Suffering from neuropathy before having chemotherapy
- Other disease that may cause neuropathy
- deafness
- Any medicine that could cause neuropathy
- Neurological or psychiatrical disease past or present
- Mental retardation
- Allergy to EMG's electrodes
- Unable to consent, under tutelage or curatorship or judiciary safeguard
- Pregnant or nursing woman
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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安慰剂比较：Nurse interview
Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
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Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
其他名称：
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实验性的：Hypnosis session
Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.
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Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the sensitive dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
大体时间：Day 84
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Day 84
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the motor dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
大体时间：Day 84
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Day 84
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the loss of autonomy of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
大体时间：Day 84
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Day 84
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Measure benefits of hypnosis on the neuropathic pain intensity
大体时间：Day 28, day 56 and Day 84.
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Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on a psychotropic treatments
大体时间：Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on analgesic treatments
大体时间：Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
大体时间：Day 84
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Day 84
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Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
大体时间：Day 84
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Day 84
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Measure benefits of hypnosis on self- hypnosis in the experimental group
大体时间：Day 28, Day 56 and D84
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Day 28, Day 56 and D84
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Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason
大体时间：Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
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Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
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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。
调查人员
- 学习椅：Caroline MAURER, Nurse、Strasbourg's University Hospitals
- 首席研究员：Raoul HERBRECHT, MD、Strasbourg's University Hospitals
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)
2017年8月4日
初级完成 (预期的)
2021年11月4日
研究完成 (预期的)
2021年11月4日
研究注册日期
首次提交
2017年3月9日
首先提交符合 QC 标准的
2017年5月15日
首次发布 (实际的)
2017年5月17日
研究记录更新
最后更新发布 (实际的)
2021年10月19日
上次提交的符合 QC 标准的更新
2021年10月18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.
Nurse interview的临床试验
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Norwegian Institute of Public HealthStatistics Norway; Society of Interventional Oncology完全的
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Norwegian Institute of Public HealthNorwegian University of Science and Technology完全的