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Hypnosis for Eye Surgery

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

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.


Condition Intervention Phase
Cataract
 Procedure: Hypnoanalgesia; Hypnotic shielding
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Correlation of Stress, Patient Comfort and Safety to Bispectral Index in Patients Under Hypnosis for Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Reduction of perioperative stress
  • Improvement of patient comfort and safety

Secondary Outcome Measures:
  • Correlation of hypnotic depth with bispectral index (BIS)

Estimated Enrollment: 70
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   10 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cataract

Exclusion Criteria:

  • Uncorrected hearing disability
  • Pharmacological beta-blockade
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176098

Contacts
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

Locations
Germany
Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg Recruiting
Mannheim, Germany, 68167
Contact: Thomas Frietsch, MD, PhD     +49 621 383 2903     thomas.frietsch@urz.uni-heidelberg.de    
Sub-Investigator: Michael Schoeler, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Study Chair: Thomas Frietsch, MD, PhD Dept. of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176098     History of Changes
Other Study ID Numbers: TF-KliMa-2005-1
Study First Received: September 12, 2005
Last Updated: February 6, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
Cataract surgery
Hypnosis
C11.510.245
F04.754.424.771
Suggestion

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013