Impact of Hypnosis During Invasive Procedure in Intensive Care Unit (HYPNOICU)
2021年6月23日 更新者：Assistance Publique - Hôpitaux de Paris
Pain during ICU stay remains one of the major complaints for patients.
Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia.
The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.
研究概览
研究类型
介入性
注册 (预期的)
124
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：Matthieu RESCHE-RIGON
- 电话号码：0142499742 0142499742
- 邮箱：matthieu.resche-rigon@univ-paris-diderot.fr
研究联系人备份
- 姓名：Virginie Lemiale
- 电话号码：+331 42 49 94 19
- 邮箱：virgnie.lemiale@aphp.fr
学习地点
-
-
-
Paris、法国
- 招聘中
- Hopital Saint-Louis
-
接触：
- Virginie Lemiale
- 电话号码：+331 42 49 94 19
-
-
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:
- Adult patients aged 18 years and older
- ICU hospitalisation
- Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)
- Physician experienced in hypnosis available
- written informed consent
- health insurance
Exclusion Criteria:
- sedation and intubation, delirium, end-of-life decision,
- deaf patient,
- patient who does not understand French language,
- pregnancy
- patient under guardianship or curatorship
- lack of health insurance
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Patients who receive hypnosis
Patients who receive hypnosis during procedure by experiment physician
|
Patients who receive hypnosis
|
|
无干预：Control arm
Patient with conventional pain management
|
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 |
|---|---|---|
|
Pain distress
大体时间：within the before and the first hour after the procedure
|
Pain distress change in the hypnosis group measured before and within the first hour after the procedure. Pain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress). |
within the before and the first hour after the procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity
大体时间：within first hour and first 24 hours after procedure
|
Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).
|
within first hour and first 24 hours after procedure
|
|
Number of adverse events
大体时间：during procedure
|
during procedure
|
|
|
Length of each painful procedure
大体时间：up to 3 months
|
up to 3 months
|
|
|
Analgesia dose
大体时间：within first and 24 hours after procedure
|
The dose of each analgesia treatment received by the patient will be collected.
|
within first and 24 hours after procedure
|
|
Type of analgesia
大体时间：within first and 24 hours after procedure
|
The type of each analgesia treatment received by the patient will be collected.
|
within first and 24 hours after procedure
|
|
Anxiety
大体时间：within first and 24 hours after procedure
|
Anxiety within first and 24 hours after procedure will be assessed using Numeric rating scale, which goes from 0 (no anxiety) to 10 (maximum anxiety imaginable).
|
within first and 24 hours after procedure
|
|
Hospital Anxiety and Depression scale
大体时间：at 3 months
|
The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome. |
at 3 months
|
|
Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)
大体时间：at 3 months
|
The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.
Items are rated on a 5-point scale ranging from 0 to 4 .
The IES-R yields a total score (ranging from 0 to 88)
|
at 3 months
|
|
Proportion of patients who had hypnosis transe
大体时间：during procedure
|
during procedure
|
|
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Description of the experience of hypnosis
大体时间：at 3 months
|
Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview
|
at 3 months
|
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。
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)
2020年9月28日
初级完成 (预期的)
2021年9月28日
研究完成 (预期的)
2021年12月18日
研究注册日期
首次提交
2020年4月29日
首先提交符合 QC 标准的
2020年5月19日
首次发布 (实际的)
2020年5月22日
研究记录更新
最后更新发布 (实际的)
2021年6月24日
上次提交的符合 QC 标准的更新
2021年6月23日
最后验证
2021年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- APHP191042
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Hypnosis group的临床试验
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的
-
Northern Illinois UniversityUniversity Autonoma de Santo Domingo终止