Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance

Study Overview
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Brief Summary
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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).

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

Conditions
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Hypnotherapy

Intervention / Treatment
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* Behavioral: Hypnotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotherapy<br> | Behavioral: Hypnotherapy<br>* Pre- (one session) and postoperative (two sessions) Hypnotherapy<br>|
| No Intervention: No Hypnotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative cognitive dysfunction at the time of discharge | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). | on day 7 - 30 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative cognitive dysfunction three months after surgery |  | three months after surgery | 
| Postoperative delirium | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Insomnia Severity Index (ISI) | Before surgery | 
| Perioperative assessment of sleep stage |  | the night after surgery;the night before discharge; 3 months after surgery |