Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance (HYPNOC)

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

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).

Study Overview

• Status: Terminated
• Conditions: Hypnotherapy
• Intervention / Treatment: Behavioral: Hypnotherapy

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotherapy	Behavioral: Hypnotherapy; Pre- (one session) and postoperative (two sessions) Hypnotherapy
No Intervention: No Hypnotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative cognitive dysfunction three months after surgery		three months after surgery
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
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
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
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
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
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
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
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
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
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
Subjective evaluation of sleep quality	Insomnia Severity Index (ISI)	Before surgery
Perioperative assessment of sleep stage		the night after surgery;the night before discharge; 3 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD Prof., Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HYPNOC