此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance (HYPNOC)

2016年8月9日 更新者：Claudia Spies、Charite University, Berlin, Germany

Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.

The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac stratum).

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

72

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

  • 德国
      • Berlin、德国、13353
        • Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin

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:

  • Patients aged 18 years and older
  • Patients scheduled for open heart surgery or spinal column surgery
  • Offered patient information and written informed consent
  • Mini Mental State > 23
  • American Society of Anesthesiologists physical status classification system (ASA) 1-3

Exclusion Criteria:

  • No informed consent
  • Patients aged <18 years
  • Patients living outside Berlin/Potsdam and surrounding area
  • Less than 5 points in Stanford Scale of Hypnotic Susceptibility: Form C; German version (SHSS:C -Weitzenhoffer & Hilgard, 1962; Bongartz, 1999 a)in the screening/recruiting phase
  • Lacking consent capability or accommodation in an institution due to an official or judicial order
  • Emergency patients or ambulant patients
  • Pregnancy and lactation
  • Coworkers at Charité
  • Lacking willingness to save and hand out data within the study
  • Insufficient knowledge of the German language
  • Participation in another trial according to the German Drug Law the week before inclusion (in the study) and the parallel participation in another trial according to the German Drug Law within the first 3 months after surgery
  • Acute, severe psychic disease (acute psychotic disorder, severe drug dependency, withdrawal symptoms)
  • Conditions which make a sufficient information and consequent consent impossible
  • The patient is under juridical supervision
  • acute risk of suicide
  • dementia
  • patients who suffer from insulin dependent Diabetes mellitus and who have been diagnosed with Diabetes mellitus within the last year
  • patients who have suffered allergic shock in the past
  • hardness of hearing, deafness, blindness
  • cardiac function: ejection fraction (EF) < 30%
  • Patients undergoing psychotherapeutic treatment
  • Patients taking awareness-modulating drugs (antipsychotic drugs)
  • Boozed/primed patients or patients under drug influence
  • Patients having had an epileptic seizure within the last four weeks
  • Patients suffering from productive cough
  • Patients having a chronic low blood pressure (systolic <90mmHg)
  • Allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment)

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
实验性的：Hypnotherapy
行为的：Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
无干预：No Hypnotherapy

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
Incidence of postoperative cognitive dysfunction at the time of discharge
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery

次要结果测量

结果测量
措施说明
大体时间
Incidence of postoperative cognitive dysfunction three months after surgery
大体时间：three months after surgery
three months after surgery
Postoperative delirium
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction in pre- and postoperative agitation and anxiety
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction of pain
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction of stress
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction of holding time
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction of hospital stay
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Reduction of Intensive Care Unit stay
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Readmission rate
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Emotional status
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
on day 7 - 30 after surgery
Functional status
大体时间：on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery)
on day 7 - 30 after surgery
Subjective evaluation of sleep quality
大体时间：Before surgery
Insomnia Severity Index (ISI)
Before surgery
Perioperative assessment of sleep stage
大体时间：the night after surgery;the night before discharge; 3 months after surgery
the night after surgery;the night before discharge; 3 months after surgery

其他结果措施

结果测量
措施说明
大体时间
Additional blood and urine tests (concerning cardiac stratum)
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
  • oxidized Parathyroid hormone and real intact, biologically active Parathyroid hormone
  • Urine: Creatinin, ionized Calcium, Phosphate
  • Calprotectin
  • S100A12
  • Arterial blood: Calcium ionized, Phosphate and potential of hydrogen (pH)
  • 3-hydroxy-3-methyl-glutaryl-CoA reductase
  • Mevalonate
  • Procalcitonin
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

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。

赞助

Charite University, Berlin, Germany

调查人员

  • 研究主任：Claudia Spies, MD Prof.、Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

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

2012年3月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2012年1月30日

首先提交符合 QC 标准的

2012年1月30日

首次发布 (估计)

2012年2月1日

研究记录更新

最后更新发布 (估计)

2016年8月10日

上次提交的符合 QC 标准的更新

2016年8月9日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • HYPNOC

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.

订阅