Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance

Hypnotherapy Clinical Trial

— HYPNOC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01523938
• Other study ID #: HYPNOC
• Status: Terminated
• Phase: N/A
• First received: January 30, 2012
• Last updated: August 9, 2016
• Start date: March 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: July 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypnotherapy

Intervention

Behavioral:
• Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional blood and urine tests (concerning cardiac stratum)	oxidized Parathyroid hormone and real intact, biologically active Parathyroid hormone; Urine: Creatinin, ionized Calcium, Phosphate; Calprotectin; S100A12; Arterial blood: Calcium ionized, Phosphate and potential of hydrogen (pH); 3-hydroxy-3-methyl-glutaryl-CoA reductase; Mevalonate; Procalcitonin	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Primary	Incidence of postoperative cognitive dysfunction at the time of discharge	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Incidence of postoperative cognitive dysfunction three months after surgery		three months after surgery	No
Secondary	Postoperative delirium	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction in pre- and postoperative agitation and anxiety	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction of pain	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction of stress	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction of holding time	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction of hospital stay	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Reduction of Intensive Care Unit stay	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Readmission rate	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Emotional status	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery).	on day 7 - 30 after surgery	No
Secondary	Functional status	Planned measures on the seventh postoperative day or on day of hospital discharge (= 30 days after surgery)	on day 7 - 30 after surgery	No
Secondary	Subjective evaluation of sleep quality	Insomnia Severity Index (ISI)	Before surgery	No
Secondary	Perioperative assessment of sleep stage		the night after surgery;the night before discharge; 3 months after surgery	No