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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01523938
First received: January 30, 2012
Last updated: October 24, 2014
Last verified: October 2014

January 30, 2012
October 24, 2014
March 2012
April 2014   (final data collection date for primary outcome measure)
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).
Incidence of postoperative cognitive dysfunction at the time of discharge [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
Complete list of historical versions of study NCT01523938 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction in pre- and postoperative agitation and anxiety [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction of pain [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction of stress [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction of holding time [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction of hospital stay [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Reduction of Intensive Care Unit stay [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Readmission rate [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Emotional status [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation).
  • Functional status [ Time Frame: on day 7 - 30 after operation ] [ Designated as safety issue: No ]
    Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after the operation)
Additional blood and urine tests (concerning cardiac stratum) [ 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
Not Provided
 
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypnotherapy
Behavioral: Hypnotherapy
Pre- (one session) and postoperative (two sessions) Hypnotherapy
  • Experimental: Hypnotherapy
    Intervention: Behavioral: Hypnotherapy
  • No Intervention: No Hypnotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
December 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01523938
HYPNOC
No
Claudia Spies, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
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
Charite University, Berlin, Germany
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP