Hypnosis for Eye Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176098
First received: September 12, 2005
Last updated: February 6, 2006
Last verified: September 2005

September 12, 2005
February 6, 2006
September 2005
Not Provided
  • Reduction of perioperative stress
  • Improvement of patient comfort and safety
Same as current
Complete list of historical versions of study NCT00176098 on ClinicalTrials.gov Archive Site
Correlation of hypnotic depth with bispectral index (BIS)
Correlation of Hypnotic Depth with BIS
Not Provided
Not Provided
 
Hypnosis for Eye Surgery
Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

Perioperative stress for cataract surgery in the elderly is considerable even in the absence of pain. For these patients with a high comorbidity level, the perioperative situation comprising factors such as uncomfortable positioning, dull ambience, face cover, poor sedation, and anxiety might not only reduce intraoperative compliance but induce cardiac ischemia and hypertensive crises. Hypnosis is supposed to increase patient comfort, to shield the patient from organic stress and to improve intraoperative compliance without side effects even in old and very ill patients. In a controlled study, we, the investigators at the University of Heidelberg, compared phakoemulsification under topical anesthesia as usual (and placebo hypnosis) with either additional hypnosis or hypnoanalgesia without topical anesthesia.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cataract
Procedure: Hypnoanalgesia; Hypnotic shielding
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
Not Provided

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Uncorrected hearing disability
  • Pharmacological beta-blockade
Both
10 Years to 95 Years
No
Contact: Thomas Frietsch, MD, PhD +49 621 383 2903 thomas.frietsch@urz.uni-heidelberg.de
Contact: Michael Schoeler, MD +49 621 383 2415 michael.schoeler@anaes.ma.uni-heidelberg.de
Germany
 
NCT00176098
TF-KliMa-2005-1
Not Provided
Not Provided
Heidelberg University
Not Provided
Study Chair: Thomas Frietsch, MD, PhD Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
Heidelberg University
September 2005

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