We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523938
First Posted: February 1, 2012
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
  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).

Condition Intervention
Hypnotherapy Behavioral: Hypnotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Claudia Spies, 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 ]
    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 ]
  • Postoperative delirium [ Time Frame: on day 7 - 30 after surgery ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Insomnia Severity Index (ISI)

  • Perioperative assessment of sleep stage [ Time Frame: the night after surgery;the night before discharge; 3 months after surgery ]

Other Outcome Measures:
  • 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 ]
    • 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


Enrollment: 72
Study Start Date: March 2012
Study Completion Date: July 2016
Primary Completion Date: April 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523938


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

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
First Submitted: January 30, 2012
First Posted: February 1, 2012
Last Update Posted: August 10, 2016
Last Verified: August 2016