Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance

Not Applicable

Terminated

• Conditions: Hypnotherapy
• Interventions: Behavioral: Hypnotherapy

• Registration Number: NCT01523938
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Study Start: 2012-03
• Primary Completion: 2014-04
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnotherapy	Hypnotherapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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	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).
Subjective evaluation of sleep quality	Before surgery	Insomnia Severity Index (ISI)
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 stress	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)
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 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).
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).

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin; 🇩🇪 Berlin, Germany