Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance
NCT ID: NCT01523938
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
72 participants
INTERVENTIONAL
2012-03-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypnotherapy
Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
No Hypnotherapy
No interventions assigned to this group
Interventions
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Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia Spies
Prof., MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM
Principal Investigators
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Claudia Spies, MD Prof.
Role: STUDY_DIRECTOR
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Locations
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Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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HYPNOC
Identifier Type: -
Identifier Source: org_study_id
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