NCT01523938终止不适用
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Incidence of postoperative cognitive dysfunction at the time of discharge
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
结局指标
主要结局
Incidence of postoperative cognitive dysfunction at the time of discharge
时间窗: on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
次要结局
- Reduction of holding time(on day 7 - 30 after surgery)
- Perioperative assessment of sleep stage(the night after surgery;the night before discharge; 3 months after surgery)
- Incidence of postoperative cognitive dysfunction three months after surgery(three months after surgery)
- Postoperative delirium(on day 7 - 30 after surgery)
- Readmission rate(on day 7 - 30 after surgery)
- Subjective evaluation of sleep quality(Before surgery)
- Reduction in pre- and postoperative agitation and anxiety(on day 7 - 30 after surgery)
- Reduction of stress(on day 7 - 30 after surgery)
- Emotional status(on day 7 - 30 after surgery)
- Functional status(on day 7 - 30 after surgery)
- Reduction of pain(on day 7 - 30 after surgery)
- Reduction of hospital stay(on day 7 - 30 after surgery)
- Reduction of Intensive Care Unit stay(on day 7 - 30 after surgery)
研究者
Claudia Spies
Prof., MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM
Charite University, Berlin, Germany
研究点 (2)
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