Hypnotherapy
Conditions
Brief summary
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).
Interventions
BEHAVIORALHypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative cognitive dysfunction at the time of discharge | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of holding time | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Incidence of postoperative cognitive dysfunction three months after surgery | three months after surgery | — |
| Postoperative delirium | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Reduction in pre- and postoperative agitation and anxiety | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Reduction of pain | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Reduction of stress | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Reduction of Intensive Care Unit stay | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Readmission rate | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Emotional status | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
| Functional status | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery) |
| Subjective evaluation of sleep quality | Before surgery | Insomnia Severity Index (ISI) |
| Perioperative assessment of sleep stage | the night after surgery;the night before discharge; 3 months after surgery | — |
| Reduction of hospital stay | on day 7 - 30 after surgery | Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional blood and urine tests (concerning cardiac stratum) | 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 |
Countries
Germany
Outcome results
None listed