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

This study is currently recruiting participants.
Verified March 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01523938
First received: January 30, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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; in cooperation with "Immundiagnostik AG")


Condition Intervention
Hypnotherapy
 Behavioral: Hypnotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Incidence of postoperative cognitive dysfunction at the time of discharge [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).


Secondary Outcome Measures:
  • Incidence of postoperative cognitive dysfunction three months after surgery [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
  • Postoperative delirium [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction in pre- and postoperative agitation and anxiety [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction of pain [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction of stress [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction of holding time [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction of hospital stay [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Reduction of Intensive Care Unit stay [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Readmission rate [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Emotional status [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).

  • Functional status [ Time Frame: on day 7 - 30 after surgery ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery)

  • Subjective evaluation of sleep quality [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
    Insomnia Severity Index (ISI)

  • Perioperative assessment of sleep stage [ Time Frame: the night after surgery;the night before discharge; 3 months after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Additional blood and urine tests (concerning cardiac stratum; in cooperation with "Immundiagnostik AG") [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypnotherapy Behavioral: Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
No Intervention: No Hypnotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523938

Locations
Germany
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD Prof.     +49 30 531 012     claudia.spies@charite.de    
Sub-Investigator: Giulia Pasciuto, MD            
Sub-Investigator: Alexander Schiemann, MD            
Sub-Investigator: Franziska Gilg, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Claudia Spies, Prof., MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01523938     History of Changes
Other Study ID Numbers: HYPNOC
Study First Received: January 30, 2012
Last Updated: March 11, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on May 19, 2013