Clinical trial NCT01523938: Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance
Official title: Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypnotherapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of postoperative cognitive dysfunction at the time of discharge
timeFrame: on day 7 - 30 after surgery
Secondary outcomes:
measure: Incidence of postoperative cognitive dysfunction three months after surgery
timeFrame: three months after surgery
measure: Postoperative delirium
timeFrame: on day 7 - 30 after surgery
measure: Reduction in pre- and postoperative agitation and anxiety
timeFrame: on day 7 - 30 after surgery
measure: Reduction of pain
timeFrame: on day 7 - 30 after surgery
measure: Reduction of stress
timeFrame: on day 7 - 30 after surgery
measure: Reduction of holding time
timeFrame: on day 7 - 30 after surgery
measure: Reduction of hospital stay
timeFrame: on day 7 - 30 after surgery
measure: Reduction of Intensive Care Unit stay
timeFrame: on day 7 - 30 after surgery
measure: Readmission rate
timeFrame: on day 7 - 30 after surgery
measure: Emotional status
timeFrame: on day 7 - 30 after surgery
measure: Functional status
timeFrame: on day 7 - 30 after surgery
measure: Subjective evaluation of sleep quality
timeFrame: Before surgery
measure: Perioperative assessment of sleep stage
timeFrame: the night after surgery;the night before discharge; 3 months after surgery
Other outcomes:
measure: Additional blood and urine tests (concerning cardiac stratum)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: