Status:
TERMINATED
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Hypnotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01523938
Start Date
March 1 2012
End Date
July 1 2016
Last Update
August 10 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin
Berlin, State of Berlin, Germany, 13353