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

Charite University, Berlin, Germany1 site in 1 country72 target enrollmentMarch 2012

ConditionsHypnotherapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypnotherapy
Sponsor: Charite University, Berlin, Germany
Enrollment: 72
Locations: 1
Primary Endpoint: Incidence of postoperative cognitive dysfunction at the time of discharge
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Claudia Spies

Prof., MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM

Charite University, Berlin, Germany

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

Outcomes

Primary Outcomes

Incidence of postoperative cognitive dysfunction at the time of discharge

Time Frame: on day 7 - 30 after surgery

Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

Secondary Outcomes

Reduction of holding time(on day 7 - 30 after surgery)
Perioperative assessment of sleep stage(the night after surgery;the night before discharge; 3 months after surgery)
Incidence of postoperative cognitive dysfunction three months after surgery(three months after surgery)
Postoperative delirium(on day 7 - 30 after surgery)
Readmission rate(on day 7 - 30 after surgery)
Subjective evaluation of sleep quality(Before surgery)
Reduction in pre- and postoperative agitation and anxiety(on day 7 - 30 after surgery)
Reduction of stress(on day 7 - 30 after surgery)
Emotional status(on day 7 - 30 after surgery)
Functional status(on day 7 - 30 after surgery)
Reduction of pain(on day 7 - 30 after surgery)
Reduction of hospital stay(on day 7 - 30 after surgery)
Reduction of Intensive Care Unit stay(on day 7 - 30 after surgery)